| CTRI Number |
CTRI/2025/07/090547 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of virgin coconut and chlorhexidine oil on oral ulcers in children |
|
Scientific Title of Study
|
Therapeutic Effectiveness of Virgin Coconut Oil versus Chlorhexidine in the Management of Recurrent Aphthous Ulcer in Children: 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 |
Aysha Lubna Salim |
| Designation |
Post Graduate Student |
| Affiliation |
Kannur Dental College |
| Address |
Department Of Pediatric And Preventive Dentistry, Room no. 2, Ground floor, Anjarakkandy, Kannur
Kannur
KERALA
670612
India |
| Phone |
9495782333 |
| Fax |
|
| Email |
ayshalubnasalim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faizal CP |
| Designation |
Professor and HOD, Department of Pediatric and Preventive Dentistry |
| Affiliation |
Professor and HOD, Department of Pediatric and Preventive Dentistry, Kannur Dental College, Kerala University of Health Sciences, Kerala |
| Address |
Department of Pediatric and Preventive Dentistry, Room no. 2, Ground Floor, Anajarakkandy, Kannur
Kannur
KERALA
670612
India |
| Phone |
9746975730 |
| Fax |
|
| Email |
drfaizalcp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aysha Lubna Salim |
| Designation |
Post Graduate Student |
| Affiliation |
Kannur Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, Room no.2, Ground Floor, Kannur Dental College, Anjarakkandy, Kannur
Kannur
KERALA
670612
India |
| Phone |
9495782333 |
| Fax |
|
| Email |
ayshalubnasalim@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Room no.2, Ground Floor, Kannur Dental College, Anjarakkandy, Kannur, Kerala, India, 670612 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatric and Preventive Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Kannur Dental College, Ground floor room no. 2, Anjarakkandy, Kannur, Kerala, India, 670612 |
| 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 Aysha Lubna Salim |
Kannur Dental College |
Department of Peditaric and Preventive Dentistry, Room no. 2, Ground Floor, Kannur Dental College, Anjarakkandy, Kannur, Kerala, India, 670612
Kannur
KERALA |
9495782333
ayshalubnasalim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE KANNUR DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K120||Recurrent oral aphthae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A: 0.12% Chlorhexidine gel |
Group A: Applied topically to the ulcer using a cotton swab, twice daily for 7 days. Duration: 7 days |
| Intervention |
Group B: Virgin Coconut Oil |
Group B: 5 mL of virgin coconut oil used for swishing twice daily for 2 minutes, for 7 days. Participants instructed to avoid eating, drinking, or rinsing for 30 minutes post-use. Duration: 7 days. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children with recurrent minor oral aphthous ulcers (up to 6mm). |
|
| ExclusionCriteria |
| Details |
1.Patients with a history of any systemic disease
2.Traumatic ulcers
3.Patients on any recent topical or systemic antibiotics or analgesics
4.History of dental surgery within one month
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain Reduction
2.Ulcer size reduction
3.Erythema level |
Day 0 (Baseline)
Day 1
Day 3
Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete Healing Achieved |
Day 7 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
25/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 a randomized single-blinded interventional trial, comparing the effectiveness of Virgin Coconut Oil and Chlorhexidine gel in managing Recurrent aphthous ulcers in children aged 11-14 years. A total of 48 participants will be equally divided into two groups. Outcomes like Pain, ulcer size and erythema will be measured on day 0,1,3 and 7. The study uses block randomization with sealed envelope allocation. The study is expected to be completed by one year. |