Caries inhibition with $ CO_{2} $-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial
Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess th...
Ausführliche Beschreibung
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| Autor*in: |
Belcheva, Ani Bozhidarova [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Anmerkung: |
© The Author(s) 2022 |
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| Übergeordnetes Werk: |
Enthalten in: Trials - London : BioMed Central, 2000, 23(2022), 1 vom: 12. März |
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| Übergeordnetes Werk: |
volume:23 ; year:2022 ; number:1 ; day:12 ; month:03 |
| Links: |
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| DOI / URN: |
10.1186/s13063-022-06117-y |
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| 520 | |a Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. | ||
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10.1186/s13063-022-06117-y doi (DE-627)SPR050550098 (SPR)s13063-022-06117-y-e DE-627 ger DE-627 rakwb eng Belcheva, Ani Bozhidarova verfasserin (orcid)0000-0002-9625-8684 aut Caries inhibition with $ CO_{2} $-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. Carbon dioxide laser (dpeaa)DE-He213 Fluoride (dpeaa)DE-He213 Orthodontic treatment (dpeaa)DE-He213 Caries inhibition (dpeaa)DE-He213 Shindova, Maria Petrova (orcid)0000-0003-2996-3700 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 12. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:12 month:03 https://dx.doi.org/10.1186/s13063-022-06117-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 AR 23 2022 1 12 03 |
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10.1186/s13063-022-06117-y doi (DE-627)SPR050550098 (SPR)s13063-022-06117-y-e DE-627 ger DE-627 rakwb eng Belcheva, Ani Bozhidarova verfasserin (orcid)0000-0002-9625-8684 aut Caries inhibition with $ CO_{2} $-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. Carbon dioxide laser (dpeaa)DE-He213 Fluoride (dpeaa)DE-He213 Orthodontic treatment (dpeaa)DE-He213 Caries inhibition (dpeaa)DE-He213 Shindova, Maria Petrova (orcid)0000-0003-2996-3700 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 12. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:12 month:03 https://dx.doi.org/10.1186/s13063-022-06117-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 AR 23 2022 1 12 03 |
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10.1186/s13063-022-06117-y doi (DE-627)SPR050550098 (SPR)s13063-022-06117-y-e DE-627 ger DE-627 rakwb eng Belcheva, Ani Bozhidarova verfasserin (orcid)0000-0002-9625-8684 aut Caries inhibition with $ CO_{2} $-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. Carbon dioxide laser (dpeaa)DE-He213 Fluoride (dpeaa)DE-He213 Orthodontic treatment (dpeaa)DE-He213 Caries inhibition (dpeaa)DE-He213 Shindova, Maria Petrova (orcid)0000-0003-2996-3700 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 12. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:12 month:03 https://dx.doi.org/10.1186/s13063-022-06117-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 AR 23 2022 1 12 03 |
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10.1186/s13063-022-06117-y doi (DE-627)SPR050550098 (SPR)s13063-022-06117-y-e DE-627 ger DE-627 rakwb eng Belcheva, Ani Bozhidarova verfasserin (orcid)0000-0002-9625-8684 aut Caries inhibition with $ CO_{2} $-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. Carbon dioxide laser (dpeaa)DE-He213 Fluoride (dpeaa)DE-He213 Orthodontic treatment (dpeaa)DE-He213 Caries inhibition (dpeaa)DE-He213 Shindova, Maria Petrova (orcid)0000-0003-2996-3700 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 12. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:12 month:03 https://dx.doi.org/10.1186/s13063-022-06117-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 AR 23 2022 1 12 03 |
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10.1186/s13063-022-06117-y doi (DE-627)SPR050550098 (SPR)s13063-022-06117-y-e DE-627 ger DE-627 rakwb eng Belcheva, Ani Bozhidarova verfasserin (orcid)0000-0002-9625-8684 aut Caries inhibition with $ CO_{2} $-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. Carbon dioxide laser (dpeaa)DE-He213 Fluoride (dpeaa)DE-He213 Orthodontic treatment (dpeaa)DE-He213 Caries inhibition (dpeaa)DE-He213 Shindova, Maria Petrova (orcid)0000-0003-2996-3700 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 12. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:12 month:03 https://dx.doi.org/10.1186/s13063-022-06117-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 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 AR 23 2022 1 12 03 |
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Caries inhibition with $ CO_{2} $-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial Carbon dioxide laser (dpeaa)DE-He213 Fluoride (dpeaa)DE-He213 Orthodontic treatment (dpeaa)DE-He213 Caries inhibition (dpeaa)DE-He213 |
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Caries inhibition with $ CO_{2} $-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial |
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Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. © The Author(s) 2022 |
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Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. © The Author(s) 2022 |
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Introduction White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative $ CO_{2} $-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of $ CO_{2} $-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. Methods and analysis This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12–18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to $ CO_{2} $-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. Registered on June 2021. © The Author(s) 2022 |
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Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student’s t test for paired samples and proportional odds logistic regression model, p<0.05. Ethics and dissemination The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University–Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov NCT04903275. 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| score |
7.4000187 |