| CTRI Number |
CTRI/2017/03/008108 [Registered on: 15/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of oral health on oral leukoplakia - a clinical trial |
|
Scientific Title of Study
|
Assessment of effect of oral health status on clinical progression of oral leukoplakia - a randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar Manne MDS |
| Designation |
Professor in Department of Oral Medicine and Radiology |
| Affiliation |
Narayana Dental College |
| Address |
Narayana Dental College
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9704014747 |
| Fax |
|
| Email |
rmannae@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothirmai Bandela |
| Designation |
Post graduate in Department of Oral Medicine and Radiology |
| Affiliation |
Narayana Dental College |
| Address |
Narayana Dental College
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9494830526 |
| Fax |
|
| Email |
drjyothirmaimandala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar Manne MDS |
| Designation |
Professor and Guide in Department of Oral Medicine and Radiology |
| Affiliation |
Narayana Dental College |
| Address |
Narayana Dental College
Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9704014747 |
| Fax |
|
| Email |
rmannae@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| The patients of outpatient department are recruited for the study. |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Rakesh Kumar Manne |
Department of Oral Medicine and Radiology, room number 1, Narayana Dental College |
Chintareddy palem, Nellore
Nellore
ANDHRA PRADESH |
9704014747
rmannae@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Oral Leukoplakia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
The control group patients will not undergo oral prophylaxis |
| Intervention |
Oral prophylaxis |
All the study group patients will undergo oral prophylaxis for one time and recalled after 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Any form of Oral Leukoplakia, homogenous/non-homogenous diagnosed
by clinical inspection and palpation.
2. Patients with Oral Leukoplakia willing to quit their tobacco habit after habit
cessation counselling. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in the study.
2. Patients not willing to quit the tobacco habit.
3. Patients who have undergone procedures required for oral health
improvement (e.g., periodontic/endodontic treatment) within last 6
months.
4. Patients who were on medication/ underwent any treatment for Oral
Leukoplakia.
5. Patients with Oral Leukoplakia along with malignant and other
premalignant conditions. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 50% regression of Oral leukoplakia size after improving oral hygiene |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Up to 100% regression of Oral leukoplakia size after improving oral hygiene |
3- 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/02/2015 |
| 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="2"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, single-centre clinical trail, assessing the effect of improving oral health on clinical regression of oral leukoplakia. The primary outcome measures will be 50% regression of oral leukoplakia size within 6 weeks. The secondary outcome will be up to 100% regression of oral leukoplakia size at 3 - 6 months. |