| CTRI Number |
CTRI/2010/091/001334 [Registered on: 30/09/2010] |
| Last Modified On: |
28/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Prevention of Dental caries through use of fluoridated mouthrinse with sugar substitutes. |
|
Scientific Title of Study
|
A comparison of anticaries efficacy of 0.2% sodium fluoride mouthrinse with and without xylitol and tirclosan : a residential school based clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
B Nandlal |
| Designation |
Professor |
| Affiliation |
JSS University |
| Address |
Dept. of Pedodontic and Preventive Dentistry JSS Dental College and Hospital, JSS University,Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
|
| Fax |
|
| Email |
dr_nandlal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B Nandlal |
| Designation |
|
| Affiliation |
Principal,JSS University |
| Address |
Professor
Dept. of Paediatric and Preventive Dentistry J S S Dental college and Hospital
Mysore
KARNATAKA
570015
India |
| Phone |
910821 2548346 |
| Fax |
910821 2548352 |
| Email |
dr_nandlal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
B Nandlal |
| Designation |
|
| Affiliation |
|
| Address |
Professor
Dept. of Paediatric and Preventive Dentistry J S S Dental college and Hospital,
Mysore
KARNATAKA
570015
India |
| Phone |
910821 2548346 |
| Fax |
910821 2548352 |
| Email |
dr_nandlal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Research fund from JSS Dental college and Hospital,Mysore |
|
Primary Sponsor
Modification(s)
|
| Name |
JSS University |
| Address |
JSS Medical Institutions campus
Mysore |
| Type of Sponsor |
Other [University] |
|
|
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 |
| Prof B Nandlal, |
JSS Free Residential school,Suttur |
J S S Dental College and Hospital,,JSS University-570015
Mysore
KARNATAKA |
910821 2548346
910821 2548352
dr_nandlal@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College and Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dental caries Prevention Through Xylitol containing Fluoridated+triclosan mouthrinse., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Fluoridated mouthrinse in addition to fluoridated Dentifrice |
10 ml weekly once, 2 minutes ,12 months |
| Intervention |
Xylitol containing fluoridated+triclosan mouthrinse in addition to fluoridated dentifrice |
10 ml weekly once, 2 minutes ,12 months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
12.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between 12 to 13 years of age.
2.All teeth should be present for that age group and fully erupted.
3.At baseline, children having plaque index ≥ 2.
4.Informed consent from the concerned person.
|
|
| ExclusionCriteria |
| Details |
1.Children who have undergone recent antibiotic therapy, suffering from chronic medical conditions ,on long term medication
2.History of early onset periodontitis, ANUG, gross oral pathology.
3. Patients on orthodontic treatment.. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque will be disclosed with a disclosing agent and the surfaces of the index tooth will be assessed using the Turskey et.al. modification (1970) of the Quigley & Hein plaque index (1962).
Gingival index (Loe & Silness) will be used to evaluate gingivitis.
Dental caries recording
|
The Comparison of results at 0 and 21 days for plaque and gingivitis and at 0 and 12 months for dental caries status. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque will be disclosed with a disclosing agent and the surfaces of the index tooth will be assessed using the Turskey et.al. modification (1970) of the Quigley & Hein plaque index (1962).
Gingival index (Loe & Silness) will be used to evaluate gingivitis.
Dental caries recording.
|
The Comparison of results at 0,7 and 21 days for plaque and gingivitis and at 0, 6 and 12 months for dental caries status. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The clinical trial will be conducted and completed in 2011 at JSS Free residential school, Suttur,Mysore Dist.India
A total of 100 children (50 girls & 50 boys) aged between 8 and 10 years studyng at the JSS Free Residential school in Suttur will be selected and divided into Xylitol containing fluoridated+triclosan mouthrinse (0.2% ,904 ppm F) test (50 children) and conventional fluoridated mouthrinse (0.2% ,904 ppm F) control (50children) groups. Rinsing will be with
10 ml mouthrinse solution for 2 minutes in both groups .
Both the groups shall be on 1000 ppm fluoridated dentifrice and toothbrushing with roll stroke method during the study period.
They will further be stratified according to age, gender, and dental caries status. After the washout period of three days, the selected children will be examined initially for plaque ,gingivitis and caries before the start of the study and later on the examination shall be carried out at 7 and 21 days for plaque and gingivitis and at 6 months and 12 months for assessment of plaque gingivitis and dental caries.
The mean plaque ,gingival scores and caries recording of the subjects who complete the study in these groups shall be done in both the groups.
Comparison between the two groups will reveal whether the Xylitol containing sodium fluoride+triclosan mouthrinse is more effective in inhibiting the progression of plaque and gingivitis and dental caries compared to the conventional fluoridated mouthrinse at a residential school mouthrinsing programme. |