Efficiency of remineralising agents on white spots lesions during braces treatment- a controlled clinical trial

Phase 2/3

Completed

Conditions: Posteruptive color changes of dental hard tissues,

Registration Number: CTRI/2020/03/024391

Lead Sponsor: Priyanka choudhary

Brief Summary: The study was conducted to determine the efficacy of three different re-mineralising agents on white spots lesions during fixed orthodontic treatment as evaluated using Digital and Visual examination method. In the study, WSLs adjacent to the orthodontic bracket were treated and monitored for a period of 6 months in adolescents who were undergoing orthodontic treatment. Young adults were selected for the study as they can follow the given instructions for using the re-mineralising agents. The total sample included in this study was 86 based on 2 methods i.e. visual examination (ICDAS II Criteria) and digital method (DIAGNODent pen). Teeth without any sign of active white spot lesions i.e. score 5 and 6 on the ICDAS scale, were excluded from the study. Teeth with a score of 2 to 4 on the labial surface as per ICDAS II criteria were selected and further assesed using DIAGNODent pen (Kavo, Germany). Teeth with a score of 0-10 when assesed using a DIAGNODent pen in the labial surface were finally selected.

The selected samples were further randomly into 4 groups- Group 1- Control group, Group 2- MI Varnish, Group 3- Clinpro creme and Group 4- Toothmin toothpaste. all the selected patients were educated and motivate to use the fluoride toothpaste (Colgate Total; 1000 ppm F) two times a day during the study period of 6 months. for patients in MI Varnish group, in-office application of varnish was done at T0. Group 3 and 4 patients were informed to use the respective re-mineralising agents two times a day during the study period of 6 months. Every patients was monitored every month and patients were asked to submit empty tubes of remineralising agents.

Patients were assesed using standard loupes for visual examination and using Diagnodent for digital examination at two intervals i.e. at T0 (at baseline) and T1( after 6 months).

In all the groups, the mean ICDAS II and DIAGNODent scores decreased from baseline (T0) to after 6 months reevaluation (T1) which confirms the efficacy of remineralization agents on the WSLs.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

no previous fixed orthodontic treatment.
permanent dentition.
fully erupted anterior teeth.
first two month of fixed appliance therapy.
no smoking habits.

Exclusion Criteria

patients with systemic problems.
enamel hypoplasia.
dental fluorosis.
intrinsic and extrinsic pigmentation.
periodontal problems.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to determine the effects of remineralising agents on white spots lesions.	at 5 month and 8 month after bonding

Secondary Outcome Measures

Name	Time	Method
to compare the effect of various remileralising agents on reduction of white spot lesions.	at 5 month and 8 month after bonding

Trial Locations

Locations (1): ITS CDSR DENTALCOLLEGE
🇮🇳
Ghaziabad, UTTAR PRADESH, India
ITS CDSR DENTALCOLLEGE
🇮🇳Ghaziabad, UTTAR PRADESH, India
DR PRIYANKA CHOUDHARY
Principal investigator
09716402593
cpriyanka864@gmail.com