Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial

Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Zeng, Qian [verfasserIn] Chen, Mingchang [verfasserIn] Zheng, Siyi [verfasserIn] Wei, Xi [verfasserIn] Liu, Hongyan [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Schlagwörter:	Vital pulp therapy Root canal treatment Carious pulp injury Mature permanent teeth

Anmerkung:	© The Author(s) 2024

Übergeordnetes Werk:	Enthalten in: Trials - BioMed Central, 2000, 25(2024), 1 vom: 21. Okt.
Übergeordnetes Werk:	volume:25 ; year:2024 ; number:1 ; day:21 ; month:10

Links:	Volltext

DOI / URN:	10.1186/s13063-024-08559-y

Katalog-ID:	SPR05793827X

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allfields	10.1186/s13063-024-08559-y doi (DE-627)SPR05793827X (SPR)s13063-024-08559-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Zeng, Qian verfasserin aut Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 Vital pulp therapy (dpeaa)DE-He213 Root canal treatment (dpeaa)DE-He213 Carious pulp injury (dpeaa)DE-He213 Mature permanent teeth (dpeaa)DE-He213 Chen, Mingchang verfasserin aut Zheng, Siyi verfasserin aut Wei, Xi verfasserin aut Liu, Hongyan verfasserin (orcid)0000-0003-2008-1787 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 21. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:21 month:10 https://dx.doi.org/10.1186/s13063-024-08559-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA 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_72 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4029 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4318 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 21 10
spelling	10.1186/s13063-024-08559-y doi (DE-627)SPR05793827X (SPR)s13063-024-08559-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Zeng, Qian verfasserin aut Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 Vital pulp therapy (dpeaa)DE-He213 Root canal treatment (dpeaa)DE-He213 Carious pulp injury (dpeaa)DE-He213 Mature permanent teeth (dpeaa)DE-He213 Chen, Mingchang verfasserin aut Zheng, Siyi verfasserin aut Wei, Xi verfasserin aut Liu, Hongyan verfasserin (orcid)0000-0003-2008-1787 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 21. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:21 month:10 https://dx.doi.org/10.1186/s13063-024-08559-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA 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_72 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4029 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4318 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 21 10
allfields_unstemmed	10.1186/s13063-024-08559-y doi (DE-627)SPR05793827X (SPR)s13063-024-08559-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Zeng, Qian verfasserin aut Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 Vital pulp therapy (dpeaa)DE-He213 Root canal treatment (dpeaa)DE-He213 Carious pulp injury (dpeaa)DE-He213 Mature permanent teeth (dpeaa)DE-He213 Chen, Mingchang verfasserin aut Zheng, Siyi verfasserin aut Wei, Xi verfasserin aut Liu, Hongyan verfasserin (orcid)0000-0003-2008-1787 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 21. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:21 month:10 https://dx.doi.org/10.1186/s13063-024-08559-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA 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_72 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4029 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4318 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 21 10
allfieldsGer	10.1186/s13063-024-08559-y doi (DE-627)SPR05793827X (SPR)s13063-024-08559-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Zeng, Qian verfasserin aut Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 Vital pulp therapy (dpeaa)DE-He213 Root canal treatment (dpeaa)DE-He213 Carious pulp injury (dpeaa)DE-He213 Mature permanent teeth (dpeaa)DE-He213 Chen, Mingchang verfasserin aut Zheng, Siyi verfasserin aut Wei, Xi verfasserin aut Liu, Hongyan verfasserin (orcid)0000-0003-2008-1787 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 21. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:21 month:10 https://dx.doi.org/10.1186/s13063-024-08559-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA 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_72 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4029 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4318 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 21 10
allfieldsSound	10.1186/s13063-024-08559-y doi (DE-627)SPR05793827X (SPR)s13063-024-08559-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Zeng, Qian verfasserin aut Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 Vital pulp therapy (dpeaa)DE-He213 Root canal treatment (dpeaa)DE-He213 Carious pulp injury (dpeaa)DE-He213 Mature permanent teeth (dpeaa)DE-He213 Chen, Mingchang verfasserin aut Zheng, Siyi verfasserin aut Wei, Xi verfasserin aut Liu, Hongyan verfasserin (orcid)0000-0003-2008-1787 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 21. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:21 month:10 https://dx.doi.org/10.1186/s13063-024-08559-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA 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_72 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_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4029 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4116 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4155 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4318 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 21 10
language	English
source	Enthalten in Trials 25(2024), 1 vom: 21. Okt. volume:25 year:2024 number:1 day:21 month:10
sourceStr	Enthalten in Trials 25(2024), 1 vom: 21. Okt. volume:25 year:2024 number:1 day:21 month:10
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Vital pulp therapy Root canal treatment Carious pulp injury Mature permanent teeth
dewey-raw	610
isfreeaccess_bool	true
container_title	Trials
authorswithroles_txt_mv	Zeng, Qian @@aut@@ Chen, Mingchang @@aut@@ Zheng, Siyi @@aut@@ Wei, Xi @@aut@@ Liu, Hongyan @@aut@@
publishDateDaySort_date	2024-10-21T00:00:00Z
hierarchy_top_id	326173552
dewey-sort	3610
id	SPR05793827X
language_de	englisch
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Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. 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spellingShingle	Zeng, Qian ddc 610 bkl 44.00 misc Vital pulp therapy misc Root canal treatment misc Carious pulp injury misc Mature permanent teeth Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial
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topic_title	610 VZ 44.00 bkl Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial Vital pulp therapy (dpeaa)DE-He213 Root canal treatment (dpeaa)DE-He213 Carious pulp injury (dpeaa)DE-He213 Mature permanent teeth (dpeaa)DE-He213
topic	ddc 610 bkl 44.00 misc Vital pulp therapy misc Root canal treatment misc Carious pulp injury misc Mature permanent teeth
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title	Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial
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title_full	Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial
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title_sort	efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial
title_auth	Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial
abstract	Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 © The Author(s) 2024
abstractGer	Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 © The Author(s) 2024
abstract_unstemmed	Background Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. Methods The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18–50 years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24 months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher’s exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. Discussion The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. Trial registration ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) (www.chictr.org.cn). Registered on 21 September 2021 © The Author(s) 2024
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title_short	Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial
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Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial

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