A clinical research to evaluate the effect of sugar free chewing gum containing CPP-ACP (a milk protein with calcium and phosphate) in prevention of white spots (initial stage of dental caries) in patients wearing braces (clip)

Phase 2/3

Completed

Brief Summary: This study is a randomized, double blind, parallel group,active controlled trial to evaluate the efficacy of sugarfree chewing gum with and without CPP-ACP in prevention of enameldemineralization around orthodontic brackets. The primary outcome measure is Vickers Hardness measurementof demineralized enamel around orthodontic brackets after 1 month use ofinterventional and control agents. The secondary outcome measure isto measure the VAS pain score due tochewing the gum in interventional groups in the first week and toidentify the number of appliance breakages in one month. The data were analysedstatistically. The results of this study showed that sugar-free gum containing CPP-ACP issuperior to an equivalent gum not containing CPP-ACP in prevention andremineralization of enamel demineralization. VAS pain scores betweenintervention and control groups showed statistically significant difference inthe pain perceived during the second day after separator placement andfirst day of activation of the arch wire. There is no statistical significancein the pain perceived during other days. There were no incidences of appliance breakage (debonding of brackets ordisplacement of arch wire) in gum chewing groups and control group over theperiod of 30 days.

Recruitment & Eligibility

Inclusion Criteria

The criteria for including participants were no active caries lesions, normal salivary flow rate (approximately 1.0 mL/min), and buffer capacity (6.7-7.7).
Sound Premolars.

Exclusion Criteria

active carious lesions, periodontal or any other oral pathology Subjects under antibiotics or any medications that could alter the salivary flow, pH & buffering capacity Dental anomaly- eg.
enamel hypoplasia , fluorosis.
Premolars- Carious/ Restored / Non vital / Fractured.
Patient with known milk protein allergy.

Primary Outcome Measures

Name	Time	Method
Vickers Hardness measurement of demineralized enamel around orthodontic brackets	one month

Secondary Outcome Measures

Name	Time	Method
Mean VAS pain score due to chewing gum	one week
to identify the number of appliance breakages	one month.

Locations (1): Government Dental College, Chennai
🇮🇳
Chennai, TAMIL NADU, India
Government Dental College, Chennai
🇮🇳Chennai, TAMIL NADU, India
Dr Shailaja R
Principal investigator
9840448313
srinishailu@gmail.com