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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MDPI AG
2022-10-01
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| author | Anju Varughese Chandrashekar Janakiram Balagopal Varma Anil Mathew Shankar Rengasamy Venugopalan Venkitachalam Ramanarayanan Prabath Singh |
| author_facet | Anju Varughese Chandrashekar Janakiram Balagopal Varma Anil Mathew Shankar Rengasamy Venugopalan Venkitachalam Ramanarayanan Prabath Singh |
| author_sort | Anju Varughese |
| collection | DOAJ |
| 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 | doaj.art-da2d974e70ef4fe2bf3cd903c863b5442023-11-24T17:02:19ZengMDPI AGMethods and Protocols2409-92792022-10-01568710.3390/mps5060087Effectiveness 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 TrialAnju Varughese0Chandrashekar Janakiram1Balagopal Varma2Anil Mathew3Shankar Rengasamy Venugopalan4Venkitachalam Ramanarayanan5Prabath Singh6Department of Conservative Dentistry and Endodontics, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Cochin 682041, IndiaDepartment of Public Health Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Cochin 682041, IndiaDepartment of Pedodontics and Preventive Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Cochin 682041, IndiaDepartment of Prosthodontics, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Cochin 682041, IndiaCollege of Dentistry and Dental Clinics, Department of Orthodontics, The University of Iowa, 801 Newton Road, Iowa City, IA 52242, USADepartment of Public Health Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Cochin 682041, IndiaDepartment of Conservative Dentistry and Endodontics, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Cochin 682041, IndiaIntroduction: 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).https://www.mdpi.com/2409-9279/5/6/87atraumatic restorative treatmentcaries arrestdental cariessilver diamine fluoridesurvival of the restoration |
| spellingShingle | Anju Varughese Chandrashekar Janakiram Balagopal Varma Anil Mathew Shankar Rengasamy Venugopalan Venkitachalam Ramanarayanan Prabath Singh 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 Methods and Protocols atraumatic restorative treatment caries arrest dental caries silver diamine fluoride survival of the restoration |
| 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 | atraumatic restorative treatment caries arrest dental caries silver diamine fluoride survival of the restoration |
| url | https://www.mdpi.com/2409-9279/5/6/87 |
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