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Effectiveness of 38% Silver Diamine Fluoride Application along with Atraumatic Restorative Treatment for Arresting Caries in Permanent Teeth When Compared to Atraumatic Restorative Treatment in Adults—Study Protocol for a Randomized Controlled Trial

Introduction: Dental caries in the adult population that require preventive and therapeutic treatment are generally neglected in rural communities. The determination of the effectiveness of the application of 38% silver diamine fluoride (SDF) in arresting caries lesions when combined with atraumatic...

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Autores principales: Varughese, Anju, Janakiram, Chandrashekar, Varma, Balagopal, Mathew, Anil, Venugopalan, Shankar Rengasamy, Ramanarayanan, Venkitachalam, Singh, Prabath
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9680478/
https://www.ncbi.nlm.nih.gov/pubmed/36412809
http://dx.doi.org/10.3390/mps5060087
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author Varughese, Anju
Janakiram, Chandrashekar
Varma, Balagopal
Mathew, Anil
Venugopalan, Shankar Rengasamy
Ramanarayanan, Venkitachalam
Singh, Prabath
author_facet Varughese, Anju
Janakiram, Chandrashekar
Varma, Balagopal
Mathew, Anil
Venugopalan, Shankar Rengasamy
Ramanarayanan, Venkitachalam
Singh, Prabath
author_sort Varughese, Anju
collection PubMed
description Introduction: Dental caries in the adult population that require preventive and therapeutic treatment are generally neglected in rural communities. The determination of the effectiveness of the application of 38% silver diamine fluoride (SDF) in arresting caries lesions when combined with atraumatic restorative treatment (ART) is very important, as it serves as a preventive and restorative procedure to regain the function of the permanent dentition. The assessment of optimal SDF application with ART, in comparison with ART alone, in managing cavitated carious lesions in a pragmatic setting, is the need of the hour to recommend optimal dental care, especially in rural settings which have minimal access to comprehensive dental care. Methods and Analysis: The clinical trial will enrol 220 adults (18–65 years) with cavitated carious lesions attending the Amrita School of Dentistry in the Ernakulam district, India. This study is a randomized, controlled trial with a 1:1 allocation ratio in two parallel groups. Study arm 1 will receive 38% SDF application and ART, and study arm 2 will receive ART only. A digital radiograph will be taken immediately after restoration (baseline) as well as at the end of the 6th month for evaluation of caries arrest. The assessment of the survival of the restoration will be done on the 7th day, 30th day, and at the end of the 6th month. The final analysis would include both the tooth and person levels. Ethics and Dissemination: This trial adheres to the principles of the Declaration of Helsinki and the guidelines of the Indian Council of Medical Research (ICMR). This study protocol has been approved by the Institutional Review Board. This trial has been registered prospectively with the Clinical Trial Registry of India (Registration No: CTRI/2021/12/038816).
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spelling pubmed-96804782022-11-23 Effectiveness of 38% Silver Diamine Fluoride Application along with Atraumatic Restorative Treatment for Arresting Caries in Permanent Teeth When Compared to Atraumatic Restorative Treatment in Adults—Study Protocol for a Randomized Controlled Trial Varughese, Anju Janakiram, Chandrashekar Varma, Balagopal Mathew, Anil Venugopalan, Shankar Rengasamy Ramanarayanan, Venkitachalam Singh, Prabath Methods Protoc Study Protocol Introduction: Dental caries in the adult population that require preventive and therapeutic treatment are generally neglected in rural communities. The determination of the effectiveness of the application of 38% silver diamine fluoride (SDF) in arresting caries lesions when combined with atraumatic restorative treatment (ART) is very important, as it serves as a preventive and restorative procedure to regain the function of the permanent dentition. The assessment of optimal SDF application with ART, in comparison with ART alone, in managing cavitated carious lesions in a pragmatic setting, is the need of the hour to recommend optimal dental care, especially in rural settings which have minimal access to comprehensive dental care. Methods and Analysis: The clinical trial will enrol 220 adults (18–65 years) with cavitated carious lesions attending the Amrita School of Dentistry in the Ernakulam district, India. This study is a randomized, controlled trial with a 1:1 allocation ratio in two parallel groups. Study arm 1 will receive 38% SDF application and ART, and study arm 2 will receive ART only. A digital radiograph will be taken immediately after restoration (baseline) as well as at the end of the 6th month for evaluation of caries arrest. The assessment of the survival of the restoration will be done on the 7th day, 30th day, and at the end of the 6th month. The final analysis would include both the tooth and person levels. Ethics and Dissemination: This trial adheres to the principles of the Declaration of Helsinki and the guidelines of the Indian Council of Medical Research (ICMR). This study protocol has been approved by the Institutional Review Board. This trial has been registered prospectively with the Clinical Trial Registry of India (Registration No: CTRI/2021/12/038816). MDPI 2022-10-26 /pmc/articles/PMC9680478/ /pubmed/36412809 http://dx.doi.org/10.3390/mps5060087 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Varughese, Anju
Janakiram, Chandrashekar
Varma, Balagopal
Mathew, Anil
Venugopalan, Shankar Rengasamy
Ramanarayanan, Venkitachalam
Singh, Prabath
Effectiveness of 38% Silver Diamine Fluoride Application along with Atraumatic Restorative Treatment for Arresting Caries in Permanent Teeth When Compared to Atraumatic Restorative Treatment in Adults—Study Protocol for a Randomized Controlled Trial
title Effectiveness of 38% Silver Diamine Fluoride Application along with Atraumatic Restorative Treatment for Arresting Caries in Permanent Teeth When Compared to Atraumatic Restorative Treatment in Adults—Study Protocol for a Randomized Controlled Trial
title_full Effectiveness of 38% Silver Diamine Fluoride Application along with Atraumatic Restorative Treatment for Arresting Caries in Permanent Teeth When Compared to Atraumatic Restorative Treatment in Adults—Study Protocol for a Randomized Controlled Trial
title_fullStr Effectiveness of 38% Silver Diamine Fluoride Application along with Atraumatic Restorative Treatment for Arresting Caries in Permanent Teeth When Compared to Atraumatic Restorative Treatment in Adults—Study Protocol for a Randomized Controlled Trial
title_full_unstemmed Effectiveness of 38% Silver Diamine Fluoride Application along with Atraumatic Restorative Treatment for Arresting Caries in Permanent Teeth When Compared to Atraumatic Restorative Treatment in Adults—Study Protocol for a Randomized Controlled Trial
title_short Effectiveness of 38% Silver Diamine Fluoride Application along with Atraumatic Restorative Treatment for Arresting Caries in Permanent Teeth When Compared to Atraumatic Restorative Treatment in Adults—Study Protocol for a Randomized Controlled Trial
title_sort effectiveness of 38% silver diamine fluoride application along with atraumatic restorative treatment for arresting caries in permanent teeth when compared to atraumatic restorative treatment in adults—study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9680478/
https://www.ncbi.nlm.nih.gov/pubmed/36412809
http://dx.doi.org/10.3390/mps5060087
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