| CTRI Number |
CTRI/2024/08/072174 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of oil pulling on pH for the prevention of white spot lesion in fixed orthodontic patients |
|
Scientific Title of Study
|
Effect of oil pulling on pH for the prevention of white spot lesion in fixed orthodontic patients - A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandiya R |
| Designation |
MDS 2nd Year Post Graduate |
| Affiliation |
karpaga vinayaga insititute of dental sciences |
| Address |
Department of orthodontics, Fourth floor, Karpaga Vinayaga institute of dental sciences, Chengalpattu
GST road, Chinna kolambakkam, Chengalpattu.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9600009054 |
| Fax |
|
| Email |
sandiyarajvel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Thirunavukkarasu R |
| Designation |
Head of the department |
| Affiliation |
karpaga vinayaga insititute of dental sciences |
| Address |
Department of orthodontics, Fourth floor, Karpaga Vinayaga institute of dental sciences, Chinna kolambakkam
GST road, Chinna kolambakkam, chengalpattu
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
|
| Fax |
|
| Email |
kidsorthodont09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddarthini |
| Designation |
|
| Affiliation |
karpaga vinayaga insititute of dental sciences |
| Address |
Department of orthodontics, Karpaga Vinayaga institute of dental sciences, Chinna kolambakkam.
GST road, Chinna kolambakkam, Chengalpattu.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
|
| Fax |
|
| Email |
siddusingh5998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthodontics, Department of microbiology, Karpaga Vinayaga institute of medical and dental sciences |
|
|
Primary Sponsor
|
| Name |
Karpaga Vinayaga institute of dental sciences |
| Address |
GST road, Chinna Kolambakkam,
Palayanoor,
Chengalpattu. |
| Type of Sponsor |
Private medical college |
|
|
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 sandiya rajvelu |
Karpaga Vinayaga institute of dental sciences |
Fourth floor, Department of orthodontics,Karpaga Vinayaga institute of dental sciences,GST road, Chinna kolambakkam, Chengalpattu
Kancheepuram
TAMIL NADU |
9789023336
sandiyarajvel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committee-Karpaga Vinayaga institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with no systemic diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal water |
normal water gargling after every meals along with modified bass brushing technique, 6 months |
| Intervention |
sesame oil |
pure sesame oil pulling 10ml, every morning, Oil pulling through mouth, 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
patients willling to participate |
|
| ExclusionCriteria |
| Details |
History of antimicrobial mouth wash and any antibiotic coverage for past 2 weeks
presence of periodontal disease
poor oral hygiene and multiple caries
history of systemic disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ph of plaque and saliva |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate colony forming unit of streptococcus unit and rate of demineralisation |
6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
23/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is randomised, single blinded study and aim of this study is to evaluate the effect of oil pulling on Ph for the prevention of white spot lesion in the fixed orthodontic patients that will be conducted in Karpaga Vinayaga institute of dental sciences, Chengalpattu. The primary outcome is to evaluate the effect of oil pulling on plaque and salivary pH and secondary outcome is to evaluate the colony forming units of streptococcus mutans and rate of teeth demineralization at baseline, 1st month, 2nd month, 4th month. |