Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial

Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions....
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Gespeichert in:

Autor*in:	Signori, Cácia [verfasserIn] Moro, Bruna Lorena Pereira [verfasserIn] Uehara, Juliana Lays Stolfo [verfasserIn] Romero, Vitor Henrique Digmayer [verfasserIn] de Oliveira, Elenara Ferreira [verfasserIn] Braga, Mariana Minatel [verfasserIn] Mendes, Fausto Medeiros [verfasserIn] Cenci, Maximiliano Sérgio [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Schlagwörter:	Caries detection Dental caries Restorations Secondary caries Caries around restorations Diagnosis Visual inspection Dental treatment Randomized clinical trial

Übergeordnetes Werk:	Enthalten in: BMC oral health - London : BioMed Central, 2001, 20(2020), 1 vom: 10. Nov.
Übergeordnetes Werk:	volume:20 ; year:2020 ; number:1 ; day:10 ; month:11

Links:	Volltext

DOI / URN:	10.1186/s12903-020-01307-z

Katalog-ID:	SPR041908422

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520			\|a Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017).
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allfields	10.1186/s12903-020-01307-z doi (DE-627)SPR041908422 (SPR)s12903-020-01307-z-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Signori, Cácia verfasserin aut Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017). Caries detection (dpeaa)DE-He213 Dental caries (dpeaa)DE-He213 Restorations (dpeaa)DE-He213 Secondary caries (dpeaa)DE-He213 Caries around restorations (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Visual inspection (dpeaa)DE-He213 Dental treatment (dpeaa)DE-He213 Randomized clinical trial (dpeaa)DE-He213 Moro, Bruna Lorena Pereira verfasserin aut Uehara, Juliana Lays Stolfo verfasserin aut Romero, Vitor Henrique Digmayer verfasserin aut de Oliveira, Elenara Ferreira verfasserin aut Braga, Mariana Minatel verfasserin aut Mendes, Fausto Medeiros verfasserin aut Cenci, Maximiliano Sérgio verfasserin aut Enthalten in BMC oral health London : BioMed Central, 2001 20(2020), 1 vom: 10. Nov. (DE-627)355500108 (DE-600)2091511-1 1472-6831 nnns volume:20 year:2020 number:1 day:10 month:11 https://dx.doi.org/10.1186/s12903-020-01307-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 10 11
spelling	10.1186/s12903-020-01307-z doi (DE-627)SPR041908422 (SPR)s12903-020-01307-z-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Signori, Cácia verfasserin aut Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017). Caries detection (dpeaa)DE-He213 Dental caries (dpeaa)DE-He213 Restorations (dpeaa)DE-He213 Secondary caries (dpeaa)DE-He213 Caries around restorations (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Visual inspection (dpeaa)DE-He213 Dental treatment (dpeaa)DE-He213 Randomized clinical trial (dpeaa)DE-He213 Moro, Bruna Lorena Pereira verfasserin aut Uehara, Juliana Lays Stolfo verfasserin aut Romero, Vitor Henrique Digmayer verfasserin aut de Oliveira, Elenara Ferreira verfasserin aut Braga, Mariana Minatel verfasserin aut Mendes, Fausto Medeiros verfasserin aut Cenci, Maximiliano Sérgio verfasserin aut Enthalten in BMC oral health London : BioMed Central, 2001 20(2020), 1 vom: 10. Nov. (DE-627)355500108 (DE-600)2091511-1 1472-6831 nnns volume:20 year:2020 number:1 day:10 month:11 https://dx.doi.org/10.1186/s12903-020-01307-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 10 11
allfields_unstemmed	10.1186/s12903-020-01307-z doi (DE-627)SPR041908422 (SPR)s12903-020-01307-z-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Signori, Cácia verfasserin aut Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017). Caries detection (dpeaa)DE-He213 Dental caries (dpeaa)DE-He213 Restorations (dpeaa)DE-He213 Secondary caries (dpeaa)DE-He213 Caries around restorations (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Visual inspection (dpeaa)DE-He213 Dental treatment (dpeaa)DE-He213 Randomized clinical trial (dpeaa)DE-He213 Moro, Bruna Lorena Pereira verfasserin aut Uehara, Juliana Lays Stolfo verfasserin aut Romero, Vitor Henrique Digmayer verfasserin aut de Oliveira, Elenara Ferreira verfasserin aut Braga, Mariana Minatel verfasserin aut Mendes, Fausto Medeiros verfasserin aut Cenci, Maximiliano Sérgio verfasserin aut Enthalten in BMC oral health London : BioMed Central, 2001 20(2020), 1 vom: 10. Nov. (DE-627)355500108 (DE-600)2091511-1 1472-6831 nnns volume:20 year:2020 number:1 day:10 month:11 https://dx.doi.org/10.1186/s12903-020-01307-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 10 11
allfieldsGer	10.1186/s12903-020-01307-z doi (DE-627)SPR041908422 (SPR)s12903-020-01307-z-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Signori, Cácia verfasserin aut Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017). Caries detection (dpeaa)DE-He213 Dental caries (dpeaa)DE-He213 Restorations (dpeaa)DE-He213 Secondary caries (dpeaa)DE-He213 Caries around restorations (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Visual inspection (dpeaa)DE-He213 Dental treatment (dpeaa)DE-He213 Randomized clinical trial (dpeaa)DE-He213 Moro, Bruna Lorena Pereira verfasserin aut Uehara, Juliana Lays Stolfo verfasserin aut Romero, Vitor Henrique Digmayer verfasserin aut de Oliveira, Elenara Ferreira verfasserin aut Braga, Mariana Minatel verfasserin aut Mendes, Fausto Medeiros verfasserin aut Cenci, Maximiliano Sérgio verfasserin aut Enthalten in BMC oral health London : BioMed Central, 2001 20(2020), 1 vom: 10. Nov. (DE-627)355500108 (DE-600)2091511-1 1472-6831 nnns volume:20 year:2020 number:1 day:10 month:11 https://dx.doi.org/10.1186/s12903-020-01307-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 10 11
allfieldsSound	10.1186/s12903-020-01307-z doi (DE-627)SPR041908422 (SPR)s12903-020-01307-z-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Signori, Cácia verfasserin aut Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017). Caries detection (dpeaa)DE-He213 Dental caries (dpeaa)DE-He213 Restorations (dpeaa)DE-He213 Secondary caries (dpeaa)DE-He213 Caries around restorations (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Visual inspection (dpeaa)DE-He213 Dental treatment (dpeaa)DE-He213 Randomized clinical trial (dpeaa)DE-He213 Moro, Bruna Lorena Pereira verfasserin aut Uehara, Juliana Lays Stolfo verfasserin aut Romero, Vitor Henrique Digmayer verfasserin aut de Oliveira, Elenara Ferreira verfasserin aut Braga, Mariana Minatel verfasserin aut Mendes, Fausto Medeiros verfasserin aut Cenci, Maximiliano Sérgio verfasserin aut Enthalten in BMC oral health London : BioMed Central, 2001 20(2020), 1 vom: 10. Nov. (DE-627)355500108 (DE-600)2091511-1 1472-6831 nnns volume:20 year:2020 number:1 day:10 month:11 https://dx.doi.org/10.1186/s12903-020-01307-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 20 2020 1 10 11
language	English
source	Enthalten in BMC oral health 20(2020), 1 vom: 10. Nov. volume:20 year:2020 number:1 day:10 month:11
sourceStr	Enthalten in BMC oral health 20(2020), 1 vom: 10. Nov. volume:20 year:2020 number:1 day:10 month:11
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Caries detection Dental caries Restorations Secondary caries Caries around restorations Diagnosis Visual inspection Dental treatment Randomized clinical trial
dewey-raw	610
isfreeaccess_bool	true
container_title	BMC oral health
authorswithroles_txt_mv	Signori, Cácia @@aut@@ Moro, Bruna Lorena Pereira @@aut@@ Uehara, Juliana Lays Stolfo @@aut@@ Romero, Vitor Henrique Digmayer @@aut@@ de Oliveira, Elenara Ferreira @@aut@@ Braga, Mariana Minatel @@aut@@ Mendes, Fausto Medeiros @@aut@@ Cenci, Maximiliano Sérgio @@aut@@
publishDateDaySort_date	2020-11-10T00:00:00Z
hierarchy_top_id	355500108
dewey-sort	3610
id	SPR041908422
language_de	englisch
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The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. 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author	Signori, Cácia
spellingShingle	Signori, Cácia ddc 610 bkl 44.00 misc Caries detection misc Dental caries misc Restorations misc Secondary caries misc Caries around restorations misc Diagnosis misc Visual inspection misc Dental treatment misc Randomized clinical trial Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial
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topic_title	610 ASE 44.00 bkl Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial Caries detection (dpeaa)DE-He213 Dental caries (dpeaa)DE-He213 Restorations (dpeaa)DE-He213 Secondary caries (dpeaa)DE-He213 Caries around restorations (dpeaa)DE-He213 Diagnosis (dpeaa)DE-He213 Visual inspection (dpeaa)DE-He213 Dental treatment (dpeaa)DE-He213 Randomized clinical trial (dpeaa)DE-He213
topic	ddc 610 bkl 44.00 misc Caries detection misc Dental caries misc Restorations misc Secondary caries misc Caries around restorations misc Diagnosis misc Visual inspection misc Dental treatment misc Randomized clinical trial
topic_unstemmed	ddc 610 bkl 44.00 misc Caries detection misc Dental caries misc Restorations misc Secondary caries misc Caries around restorations misc Diagnosis misc Visual inspection misc Dental treatment misc Randomized clinical trial
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title	Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial
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title_full	Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial
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author_browse	Signori, Cácia Moro, Bruna Lorena Pereira Uehara, Juliana Lays Stolfo Romero, Vitor Henrique Digmayer de Oliveira, Elenara Ferreira Braga, Mariana Minatel Mendes, Fausto Medeiros Cenci, Maximiliano Sérgio
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title_sort	study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the caries cognition and identification in adults (cacia) trial
title_auth	Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial
abstract	Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017).
abstractGer	Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017).
abstract_unstemmed	Background The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults. Methods The design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%. Discussion This is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth. Trial registration NCT03108586 (registered 11 April 2017).
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title_short	Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial
url	https://dx.doi.org/10.1186/s12903-020-01307-z
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Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial

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