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
Abstract
:1. Introduction
2. Methods
2.1. Study Design
2.2. Study Settings
2.3. Trial Registration
2.4. Study Population
2.5. Eligibility Criteria
2.5.1. Inclusion Criteria
- Male or female individuals, between the age of 18 to 65 years, with either one of the following: Class 1 caries (only occlusal surface involved in posterior teeth) or Class 2 caries (occlusal and proximal surface of posterior teeth), without involving the pulp.
- Patients understand the significance of SDF and ART for the treatment and prevention of tooth decay.
- Patients are willing to attend the follow-up visits as required for the trial.
- Patients will be enrolled irrespective of special needs if they are willing and able to comply with all the trial requirements.
- Patients with the absence of periodontal disease.
2.5.2. Exclusion Criteria
- Patient with stomatitis or ulcerative gingivitis.
- Developmental abnormalities of enamel and dentin.
- Serious non-communicable medical conditions include cardiac failure and poor glycaemic control.
- Cavitated teeth missing greater than a third of the coronal tooth structure or having pulpal involvement. Pulp-exposed tooth, obvious discoloration, premature hypermobility, or presence of a periapical abscess or a sinus will be regarded as a tooth with pulpal involvement.
- Known silver allergy.
- During the intervention, if there is inadvertent pulp exposure, the patient will be excluded from the study.
2.6. Definition of Study Condition (Dental Caries)
2.7. Interventions
2.8. Primary Outcomes
2.8.1. Assessment of Survival of the Restoration
2.8.2. Radiographic Evaluation of Caries Arrest of the Lesion
2.9. Secondary Outcome
2.10. Participation Timeline
2.11. Sample Size
2.12. Study Implementation
2.13. Compliance with Trial Treatment
2.14. Adverse Events
3. Close-Out Procedures
4. Statistical Methods
- The intention-to-treat analysis (including all randomized patients irrespective of whether they have or have not received the prescribed treatment).
- The per-protocol analysis.
5. Analysis of Population and Missing Data
6. Patient and Public Involvement
7. Ethics and Dissemination
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
References
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Enrolment | Allocation | Post Allocation | Close Out | |||
---|---|---|---|---|---|---|
Time Point | t-1 | t0 | t1 (7 days) | t2 (30 days) | t3 (6 months) | tx |
Enrolment | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Allocation | X | |||||
Caries excavation | X | |||||
Interventions | ||||||
38% SDF + ART | ||||||
ART | ||||||
Assessments | ||||||
Baseline variables cavitated carious lesion | X | X | X | X | ||
Caries arrest | X | X | X | X | ||
Survival of restoration | X | X | X | X |
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Varughese, A.; Janakiram, C.; Varma, B.; Mathew, A.; Venugopalan, S.R.; Ramanarayanan, V.; Singh, P. 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 Protoc. 2022, 5, 87. https://doi.org/10.3390/mps5060087
Varughese A, Janakiram C, Varma B, Mathew A, Venugopalan SR, Ramanarayanan V, Singh P. 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. 2022; 5(6):87. https://doi.org/10.3390/mps5060087
Chicago/Turabian StyleVarughese, Anju, Chandrashekar Janakiram, Balagopal Varma, Anil Mathew, Shankar Rengasamy Venugopalan, Venkitachalam Ramanarayanan, and Prabath Singh. 2022. "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 5, no. 6: 87. https://doi.org/10.3390/mps5060087
APA StyleVarughese, A., Janakiram, C., Varma, B., Mathew, A., Venugopalan, S. R., Ramanarayanan, V., & Singh, P. (2022). 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, 5(6), 87. https://doi.org/10.3390/mps5060087