| CTRI Number |
CTRI/2022/12/048322 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
18/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of the efficacy of various treatment modalities in the management of mouth opening, burning sensation in oral submucous fibrosis |
|
Scientific Title of Study
|
Efficacy of treatment modalities of oral submucous fibrosis at clinical and histopathological level-Comparing intralesional corticosteroids in combination with hyaluronidases therapy, soft LASER (ErCr:YSGG)fibrotomy and intralesional autologous platelet-rich-plasma - A Prospective 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 |
Mekala Mary Sujatha |
| Designation |
Assistant professor |
| Affiliation |
Government dental college and hospital vijayawada |
| Address |
Room no:1 Department of oral medicine and radiology
Government Dental College and Hospital, Gunadala, Vijayawada Room no 1,Department of oral medicine and radiology
Vishnu dental college, Vishnupur, Bhimavaram
West Godavari ANDHRA PRADESH 520004 India |
| Phone |
8179351022 |
| Fax |
|
| Email |
mmsujatha1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr T Ramesh |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College and Hospital |
| Address |
Room no:1,
Department of Oral medicine and radiology, Vishnu Dental College,Vishnupur,Bhimavaram-
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9440847997 |
| Fax |
|
| Email |
drramesht@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr T Ramesh |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College and Hospital |
| Address |
Room no:1,
Department of Oral medicine and radiology, Vishnu Dental College,Vishnupur,Bhimavaram-
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9440847997 |
| Fax |
|
| Email |
drramesht@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital, Vijayawada Krishna District, Andhra Pradesh |
| Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr M Mary Sujatha |
| Address |
Room no:1,
Department of Oral medicine and radiology, Government Dental College and Hospital, Vijayawada, Andhra Pradesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Mary Sujatha |
Government Dental College and Hopsital |
Room no:1, Department of Oral Medicine and Radiology, Government Dental College and Hopsital, Vijayawada Krishna ANDHRA PRADESH |
8179351022
mmsujatha1@gmail.com |
| Dr M Mary Sujatha |
Vishnu Dental College and Hospital |
Room no:1,
Department of Oral Medicine and Radiology, Vishnu Dental College and Hospital Vishnupur Bhimavaram West Godavari ANDHRA PRADESH |
8179351022
mmsujatha1@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
| Institutional Ethics Committee |
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 |
Erbium Chromium Yttrium Scandium Gallium Garnet (ErCr: YSGG) soft LASER fibrotomy |
Erbium Chromium Yttrium Scandium Gallium Garnet (ErCr: YSGG) soft LASER fibrotomy once will be done |
| Comparator Agent |
Intralesional Corticosteroids in combination with hyaluronidases therapy |
Corticosteroids (Inj. Dexamethasone 4mg) and Hyaluronidases
(Inj Hyaluronidase 1500iu) will be given intralesionally once in a week in submucosal plane at multiple sites of palpable fibrous bands for 6 weeks. |
| Intervention |
Platelet rich plasma therapy |
Autologous PRP 5ml will be given intralesionally in submucosal plane at multiple sites of palpable fibrous bands at about 0.5ml per 1cm2 using 25-gauge needle for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. The individuals who gave a positive history of Areca nut/ Ghutka / Betel Quid chewing.
2. The criteria for the presence of the disease according to clinical staging and clinical inspection:Burning sensation, the presence of fibrous bands, Restricted mouth opening.
3. Histologically proven oral submucous fibrosis.
|
|
| ExclusionCriteria |
| Details |
1 Patient with blood-borne diseases
2 Medically compromised patients
3 Anti-coagulant therapy
4 Immunosuppressive therapy
5 Critical thrombocytopenia (low platelet count)
6 Hypofibrinogenemia.
7 Hemodynamic instability
8 Individuals with history of any systemic disease and undergoing treatment.
9 Individuals not willing to be a part of study |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know efficacy of the each treatment modality Intralesional Injections, PRP injections, Laser therapy in Oral submucous fibrosis clinically in reduction of fibrous bands, burning sensation of mouth increase in mouth opening. |
1. Reduction of fibrous bands: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months.
2. Reduction in burning sensation of mouth: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months.
3. Increase in mouth opening: 1, 2, 3, 4, 5, 6 weeks and 3, 6, 9 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
01/06/2023 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral submucous fibrosis is the most common potentially malignant disorder of Indian subcontinent resulting in severe morbidity of trismus. In the present study four treatment modalities like intralesional Corticosteroids, Intralesional Hyaluronidase, Intralesional autologous Platelet-rich-plasma and LASER(Er-Cr-YSGG) fibrotomy have been selected to treat each group of patients randomly. This study is a Prospective Randomized Clinical four-arm Trail of the sample size 84 subjects. Each group has 21 subjects are intended to know the efficacy of the four treatment modalities clinically and histologically. Each subject of the three intralesional groups are treated weekly once for 6 weeks respectively. The LASER fibrotomy is undertaken in fourth group. Each subject of all the groups is followed at an interval of 3months, 6months,9months for the prognostic changes of clinical symptoms. The outcomes are subjected to statistical analysis using G*power. One way analysis of variance. Type1 - error of 5%, Effect size :0.8. Anticipated dropout rate 10%. Each variant of clinical symptoms is compared among the groups anticipating the hypothesis of intralesional autologous Platelet-rich-plasma is novel less invasive regenerative, remodeling treatment modalities and patient compliance in reducing morbid conditions like trismus. |