Comparison of effectiveness of Fluoride containing paint and glue used during braces treatment in reducing and treating initial caries on teeth

Completed

• Conditions: Dental caries on smooth surface, (2) ICD-10 Condition: R52||Pain, unspecified,

• Registration Number: CTRI/2021/11/037918
• Lead Sponsor: ICMR

Brief Summary

Dental Caries is the most common chronic disease worldwide. WSLs(White Spot Lesion) represent the first clinical observation of the progression of dental caries.4,5,6It has been found that the prevalence of WSL can rise from 32% before treatment to74% after treatment with fixed Orthodontic braces.Fluoride which is an important agent in preventing dental caries,14 has been used in various forms to prevent and treat WSLs.

However, according to the Cochrane review in 2013, only one study has been judged to be at low risk of bias and no study has evaluated patient related outcomes with the use of flourides. The flaws in the previous studies were: qualitative methods of diagnosis of WSls, inappropriate long term follow-up, non standardization of control group and limited number of patients enrolled.Also, focus should be in developing strategies that are independent of patient compliance. Hence further adequately powered double blind RCTS are required to find the best means of preventing WSLs.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-29
• Study Completion: 2024-11-25
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

class I malocclusion with arch length tooth material discrepancy more than 6 mm.

Exclusion Criteria

patients with hypocalified teeth or dental flourosis endocrine disorders,congenital anomalies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effectiveness of 2 modes of fluoride delivery agents (fluoride varnish and fluoride containing bonding agent) in preventing and reducing the size of lesions, if they developed during the fixed orthodontic treatment.	Time in months | 1-4 months | Training of research associate and enrollment of patients | 5-30 months:Implementation of project | :rendering treatment to patients | 31-36 months | Data Analysis and compilation of result
2. To compare the results of the 2 above mentioned fluoride delivery modes, with that of the control group.	Time in months | 1-4 months | Training of research associate and enrollment of patients | 5-30 months:Implementation of project | :rendering treatment to patients | 31-36 months | Data Analysis and compilation of result
3. To assess participant related outcomes, such as perception of WSLs and adverse effects due to the 2 agents.	Time in months | 1-4 months | Training of research associate and enrollment of patients | 5-30 months:Implementation of project | :rendering treatment to patients | 31-36 months | Data Analysis and compilation of result

Secondary Outcome Measures

Name	Time	Method
To assess participant related outcomes, such as perception of WSLs and adverse effects due to the 2 agents.	Time in months1-4 5-30 months 31-36 months

Trial Locations

Locations (1)

faculty of dentistry, jamia millia islamia; 🇮🇳 South, DELHI, India

faculty of dentistry, jamia millia islamia

🇮🇳South, DELHI, India

drsanjay miglani

Principal investigator

9999208880

smiglani@jmi.ac.in