| CTRI Number |
CTRI/2024/11/076897 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing the Effect of Virgin Coconut Oil and Miconazole in Treating Denture Stomatitis |
|
Scientific Title of Study
|
Evaluation of the efficacy of virgin coconut oil as compared to Miconazole in the treatment of denture stomatitis; an in vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandakumar Subramanian |
| Designation |
PG Student |
| Affiliation |
|
| Address |
Department of Prosthodontics,Room No: 5, Kannur Dental College, Anjarakandy (p.o.), Kannur
Kannur
KERALA
670612
India |
| Phone |
09605606373 |
| Fax |
|
| Email |
nandunnn007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nishna Pradeep |
| Designation |
Professor and Head |
| Affiliation |
Kannur Dental College |
| Address |
Department of Prosthodontics, Room No:5, Kannur Dental College, Anjarakandy (p.o.), Kannur
Kannur
KERALA
670612
India |
| Phone |
09605606373 |
| Fax |
|
| Email |
drnishnapradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nandakumar Subramanian |
| Designation |
PG Student |
| Affiliation |
|
| Address |
Department of Prosthodontics, Room No: 5, Kannur Dental College, Anjarakandy (p.o.), Kannur
Kannur
KERALA
670612
India |
| Phone |
09605606373 |
| Fax |
|
| Email |
nandunnn007@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. Nandakumar, Post Graduate Student, Department of Prosthodontics, Room No:5, Anjarakandy (p.o.), Kannnur, Kerala, India
PIN: 670612 |
|
|
Primary Sponsor
|
| Name |
S Nandakumar |
| Address |
Department of Prosthodontics, Room No: 5, Kannur Dental College, Anjarakandy (p.o.), Kannur
PIN: 670612 |
| 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 S Nandakumar |
Kannur Dental College |
Department of Prosthodontics, Room No: 5, Kannur Dental College, Anjarakandy (p.o.), Kannur
PIN: 670612
Kannur
KERALA |
8547157100
nandunnn007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kannur Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients wearing Dentures that cover the palate; Complete or Partial Removeable Dentures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Miconazole Cream |
Treatment of denture stomatitis using miconazole antifungal cream
The patient is asked to apply 2% Miconazole cream on the palate 2 times a day, after meals, for 6 months. |
| Intervention |
Virgin coconut oil |
Treatment of Denture stomatitis using Virgin coconut oil:
The patient is asked to apply 5 ml Virgin coconut oil on the palate 2 times a day, after meals, for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients wearing dentures that cover the entire palate, i.e., complete dentures or partial dentures of the maxillary arch.
2. Patients who present with Type I, Type II or Type III denture stomatitis (According to Newton’s classification).
|
|
| ExclusionCriteria |
| Details |
1. Patients who are medically immunocompromised and thus more susceptible to repeated candida infection
2. Patients with uncontrolled diabetes (HbA1c% above 8%)
3. Patients undergoing chemo or radiotherapy
4. Patients with renal insufficiency
5. Patients with AIDS
6. Patients who have undergone organ transplant
7. Patients who have undergone recent or multiple surgeries
8. Patients who are pregnant or nursing
9. Patients with xerostomia
10. Patients who had taken antibiotics or antifungal agents in the past 4 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution of denture stomatitis |
1-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No resolution of denture stomatitis |
1-6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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)
|
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
|
A 6 month study aimed to compare the effects of virgin coconut oil and miconazole cream on denture stomatitis. The evaluation is done via visual observation as well as microbiological culture study to detect the presence or absence of candida albicans, which is the major cause for denture stomatitis. |