| CTRI Number |
CTRI/2024/02/062636 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [NEEM AND DEXAMETHASONE MOUTHWASH] |
| Study Design |
Other |
|
Public Title of Study
|
Comparative evaluation of efficiency of Neem mouthwash versus Dexamethasone mouthwash in management of oral submucous fibrosis: A Randomized clinical trial |
|
Scientific Title of Study
|
"Comparative evaluation of efficacy of neem mouthwash versus dexamethasone mouthwash as an adjuvant in the symptomatic management of oral submucous fibrosis: 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 |
POKURU APARNA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
NARAYANA DENTAL COLLEGE & HOSPITAL |
| Address |
NARAYANA DENTAL COLLEGE AND HOSPITAL
Dept of Oral Medicine & Radiology Room no 1 Ground floor
CHINTHAREDDYPALEM
NELLORE
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8179805938 |
| Fax |
|
| Email |
aparnapokuru21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rakesh kumar manne |
| Designation |
Professor |
| Affiliation |
NARAYANA DENTAL COLLEGE & HOSPITAL |
| Address |
NARAYANA DENTAL COLLEGE AND HOSPITAL
Dept of Oral Medicine and Radiology room no 1 ground floor
CHINTHAREDDYPALEM
NELLORE
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8179805938 |
| Fax |
|
| Email |
rmannae@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
POKURU APARNA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
NARAYANA DENTAL COLLEGE & HOSPITAL |
| Address |
NARAYANA DENTAL COLLEGE AND HOSPITAL
Dept of Oral medicine and Radiology Room no 1 Ground floor
CHINTHAREDDYPALEM
NELLORE
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8179805938 |
| Fax |
|
| Email |
aparnapokuru21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College & Hospital
Dept of Oral Medicine & radiology
room no 1 ground floor
chinthareddypalem Nellore
524003 |
| self funding |
|
|
Primary Sponsor
|
| Name |
POKURU APARNA |
| Address |
NARAYANA DENTAL COLLEGE AND HOSPITAL, CHINTHAREDDYPALEM, NELLORE |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| POKURU APARNA |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
NARAYANA DENTAL COLLEGE AND HOSPITAL
Dept of Oral Medicine and Radiology
Room no 1
Ground floor
Nellore
ANDHRA PRADESH |
8179805938
aparnapokuru21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC, NDCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NEEM MOUTH WASH |
10ML DILUTED WITH 10ML OF WATER
2 times daily for 1 week |
| Comparator Agent |
DEXAMETHASONE MOUTH WASH |
0.5MG DEXAMETHASONE TABLET IN 20ML OF WATER
2 times daily for 1 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 PATIENTS ABOVE THE AGE OF 18 YEARS CLINICALLY DIAGNOSED WITH ORAL SUBMUCOUS FIBROSIS.
2 PATIENTS WILLING TO PATICIPATE IN THE STUDY.
3 PATIENTS WILLING TO QUIT THE HABIT AS INSTRUCTED.
|
|
| ExclusionCriteria |
| Details |
1 PATIENTS WHO ARE ALREADY UNDERGOING TREATMENT FOR ORAL SUBMUCOUS FIBROSIS.
2 PATIENTS WITH TMJ PROBLEMS, PERICORONITIS OF LOWER THIRD MOLARS ETC,WHICH MAY CAUSE REDUCED MOUTH OPENING.
3 PATIENTS WITH PAST HISTORY OF TB. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| THERE WILL BE REDUCTION IN BURNING SENSATION OF MOUTH. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| THERE WILL BE INCREASE IN INTERINCISAL MOUTH OPENING |
1 WEEK |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
23/02/2024 |
| Date of Study Completion (Global) |
20/12/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The article is yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A total number of 60 patients diagnosed to be having Oral submucous fibrosis were randomly categorized into two groups i.e. Group A and Group B. Each Group consisted of 30 patients. Group A patients were given Neem mouthwash and Group B patients were given Dexamethasone mouthwash 2 times daily for 1 week. Patients in both the groups were advised to hold the mixture of mouthwash in mouth for 4-5 min and advised to spit out after using it in the mouth as a rinse. Patients were advised for cessation of habits prior to start of treatment regime and was instructed to use the mouthwash for one week and recalled for follow up after 1 week. The recordings of interincisal mouth opening and burning sensation were recorded pre and post treatment. Intensity of Burning sensation was recorded using Visual analogue scale (VAS) and Inter incisal mouth opening were measured using scale and divider. And the data was recorded and sent to statistical analysis. |