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
|
|
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
|
|
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
|
|
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. The primary outcome measure is Vickers Hardness measurement
of demineralized enamel around orthodontic brackets after 1 month use of
interventional and control agents. The secondary outcome measure is
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. |