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CTRI Number  CTRI/2018/01/011495 [Registered on: 23/01/2018] Trial Registered Retrospectively
Last Modified On: 18/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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) 
Scientific Title of Study   Efficacy of sugar free chewing gum containing casein phosphopeptide amorphous calcium phosphate (CPP-ACP) on demineralization around fixed orthodontic brackets - An in vivo study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailaja R 
Designation  PG student 
Affiliation  TN Government Dental College 
Address  Department of orthodontics and Dentofacial Orthopedics,
TN Government Dental College, Chennai – 600003
Chennai
TAMIL NADU
600078
India 
Phone  9840448313  
Fax    
Email  srinishailu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vimala 
Designation  Professor and HOD 
Affiliation  TN Government Dental College 
Address  Department of orthodontics and Dentofacial Orthopedics,
TN Government Dental College, Chennai
Chennai
TAMIL NADU
600003
India 
Phone  9884417095  
Fax    
Email  vimalaortho@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shailaja R 
Designation  PG student 
Affiliation  TN Government Dental College 
Address  Department of orthodontics and Dentofacial Orthopedics,
TN Government Dental College, Chennai – 600003
Chennai
TAMIL NADU
600078
India 
Phone  9840448313  
Fax    
Email  srinishailu@gmail.com  
 
Source of Monetary or Material Support  
Self funded 
 
Primary Sponsor  
Name  Dr Shailaja R 
Address  PG Student, Department of orthodontics and Dentofacial Orthopedics, TN Government Dental College, Chennai – 600003  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailaja R  Government Dental College, Chennai  Department of orthodontics and Dentofacial Orthopedics, TN Government Dental College, Chennai – 600003
Chennai
TAMIL NADU 
9840448313

srinishailu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, TN Government Dental College and Hospital, Chennai – 600003  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Enamel Demineralization around orthodontic patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No chewing gum.  only routine oral hygeine method. (Brushing twice daily with usually prescribed fluoride tooth paste) 
Intervention  Sugar free chewing gum containing CPP-ACP   Two pellets thrice daily for one month  
Intervention  Sugar free chewing gum without CPP-ACP   Two pellets thrice daily for one month  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Vickers Hardness measurement of demineralized enamel around orthodontic brackets  one month 
 
Secondary Outcome  
Outcome  TimePoints 
Mean VAS pain score due to chewing gum  one week 
to identify the number of appliance breakages  one month. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "9"
Final Enrollment numbers achieved (India)="9" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/02/2017 
Date of Study Completion (India) 03/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   This study has not been published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study is a randomized, double blind, parallel group, active controlled trial to evaluate the efficacy of sugar free chewing gum with and without CPP-ACP in prevention of enamel demineralization around orthodontic brackets. Thprimary outcome measuris Vickers Hardness measurement of demineralized enamel around orthodontic brackets after 1 month use of interventional and control agents. Thsecondary outcome measuris to measure the VAS pain score due to chewing the gum in interventional groups in the first week and to identify the number of appliance breakages in one month. The data were analysed statistically. The results of this study showed that sugar-free gum containing CPP-ACP is superior to an equivalent gum not containing CPP-ACP in prevention and remineralization of enamel demineralization. VAS pain scores between intervention and control groups showed statistically significant difference in the pain perceived during the second day after separator placement and first day of activation of the arch wire. There is no statistical significance in the pain perceived during other days. There were no incidences of appliance breakage (debonding of brackets or displacement of arch wire) in gum chewing groups and control group over the period of 30 days.

 
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