| CTRI Number |
CTRI/2020/12/029661 [Registered on: 09/12/2020] Trial Registered Prospectively |
| Last Modified On: |
20/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Remineralization efficacy of CPP-ACP with Fluoride versus Sodium Fluoride mouthrinse on white spot lesions among orthodontic patients |
|
Scientific Title of Study
|
Remineralization efficacy of CPP-ACP with Fluoride versus Sodium Fluoride mouthwash on white spot lesions among orthodontic patients-
A Randomized Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Mahapatra |
| Designation |
Post graduate student |
| Affiliation |
Sudha Rustagi College of Dental Science and Research |
| Address |
Room no 3, ground floor, Department of Public Health Dentistry, Sudha Rustagi College of Dental Science and Research, Kheri More,Bhopani, Sector 89
Faridabad
HARYANA
121001
India |
| Phone |
7381026618 |
| Fax |
|
| Email |
soumyasam9218@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Nagpal |
| Designation |
Professor |
| Affiliation |
Sudha Rustagi College of Dental Science and Research |
| Address |
Department of Public Health Dentistry,Department No-3,Sudha Rustagi College of Dental Science and Research, Kheri More,Bhopani, Sector 89, Near Piyush heights, Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9811415169 |
| Fax |
|
| Email |
drruchinagpal1975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CM Marya |
| Designation |
Professor and Head |
| Affiliation |
Sudha Rustagi College of Dental Science and Research |
| Address |
Department of Public Health Dentistry,Department No-3,Sudha Rustagi College of Dental Science and Research, Kheri More,Bhopani, Sector 89, Near Piyush heights, Faridabad
Faridabad
HARYANA
121001
India |
| Phone |
9811144408 |
| Fax |
|
| Email |
maryacm@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Self funded (Dr Soumya)Department of Public Health Dentistry,Department No-3,Sudha Rustagi College of Dental Science and Research, Kheri More,Bhopani, Sector 89, Near Piyush heights, Faridabad |
|
|
Primary Sponsor
|
| Name |
Self funded Dr Soumya |
| Address |
Department of Public Health Dentistry,Department No-3,Sudha Rustagi College of Dental Science and Research, Kheri More,Bhopani, Sector 89, Near Piyush heights, Faridabad |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Soumya Mahapatra |
Sudha Rustagi College of Dental Science and Research, Kheri More,Bhopani, Sector 89, |
Room no 3, ground floor, Department of Public Health Dentistry, Sudha Rustagi College of Dental Science and Research, Kheri More,Bhopani, Sector 89
Faridabad
HARYANA |
7381026618
soumyasam9218@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GC TOOTH MOUSSE PLUS |
GROUP A will be given GC Tooth Mousse Plus and will be instructed to brush with a fluoride toothpaste in the morning and night and then
1.Apply a pea size amount of GC Tooth Mousse Plus to the upper and lower teeth using a clean dry finger or cotton tip.
2.Leave GC Tooth Mousse Plus on the teeth undisturbed for a minimum of 3 minutes.
3.Then use your tongue to spread the remaining GC Tooth Mousse Plus throughout the mouth and hold it in the mouth for as long as possible (a further 1-2 minutes) avoiding expectoration.
4.Expectorate thoroughly and if possible avoid rinsing.
5.Do not eat or drink for 30 minutes following application.
GC tooth mousse to use twice daily for 3 months
|
| Comparator Agent |
Sodium fluoride mouth rinse |
Group B will be given Sodium Fluoride Mouthrinse and are instructed to
1.Take the indicated amount of mouthrinse on the label.
2.Swish the rinse vigorously in the mouth for 2-3 minutes.
3.Expectorate thoroughly and if possible avoid rinsing.
4.Do not eat or drink for 30 minutes following application.
Use the fluoride mouthrinse twice daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Orthodontic patients with fixed orthodontic appliances on the facial surface of the maxillary and mandibular incisors, and canines.
2.Subjects of 12 years age or above.
3.Subjects with atleast two active white spot lesions (Nyvad criteria) on the facial surface of the maxillary, mandibular incisors and canine at the time of recruitment of study subjects.
4.Subjects with verifiable records of bonding with non-sealing and non-fluoride releasing bonding agents/cements.
5.Subjects with at least 12 months of fixed appliance therapy remaining from the time of recruitment.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with milk protein allergy,
2.Subjects with untreated cavitated lesions or extensive restorations on the facial surfaces of the study teeth,
3.Subjects with intrinsic or extremely heavy extrinsic staining on facial surface of the maxillary, mandibular incisors and canine.
4.Subjects with moderate to severe fluorosis,
5.Subjects with dental morphologic/ anatomical/developmental anomalies
6.Subjects with any medical illness/or on any medications for dental or systemic disease.
7.Planned to relocate or move within 6 months of enrolment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Remineralization efficacy of CPP-ACP with Fluoride in terms of EDI and ICDAS scores |
Baseline, 1st week , 2nd week , 3rd week , 1 month , 2nd month and 3rd month |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A
new product, GC Tooth Mousse Plus, is currently available and has been shown in
some initial reports to be useful in the reduction of white spot lesions.
Although GC Tooth Mousse Plus does not remove the need for compliance, it is
hoped that it provides a new way to prevent and resolve decalcifications that
develop during orthodontic treatment. GC Tooth Mousse Plus reportedly restores
minerals to the teeth and helps to stimulate saliva production. This product
contains 900 p.p.m. fluoride with added calcium and phosphate, in a composition
ideal for depositing fluorapatite into enamel. A crucial component of the
product is the milk-derived protein casein phosphopeptide (CPP), which
stabilizes amorphous calcium phosphate (ACP). This is converted to fluorapatite
deposited in enamel by the available fluoride.11
There
are few studies regarding the effect of calcium phosphate and hydroxyapatite
based agents on remineralization and optical appearance of WSLs following
orthodontic therapy. The results of a recent systematic review suggest that
there is a tendency toward a benefit for the use of GC Tooth Mousse Plus over
brushing with a fluoride toothpastemouthrinse for regression of WSLs in
orthodontic patients but the quality of evidence is limited. With this
background this study will be conducted to evaluate the remineralization
efficacy of CPP-ACP with fluoride (GC Tooth Mousse Plus) and Sodium Fluoride mouthrinse
on white spot lesions during orthodontic treatment. |