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CTRI Number  CTRI/2026/02/104032 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 14/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different surgical procedures to treat reduced mouth opening in oral submucous fibrosis patients.  
Scientific Title of Study   Surgical management of oral submucous fibrosis with seagull flap (modified nasolabial flap) and standard nasolabial flap: A clinical comparative 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  Dr Het Dave 
Designation  Resident Doctor 
Affiliation  Faculty Of Dental Science, Dharmsinh Desai University. 
Address  Department Of Oral and Maxillofacial Surgery, Faculty Of Dental Science, Dharmsinh Desai University, College Road, Nadiad

Kheda
GUJARAT
387001
India 
Phone  7405552000  
Fax  2682520501  
Email  davehet000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hiren Patel 
Designation  Dean, Professor and Head Of Department. 
Affiliation  Faculty Of Dental Science, Dharmsinh Desai University. 
Address  Department Of Oral and Maxillofacial Surgery, Faculty Of Dental Science, Dharmsinh Desai University, College Road, Nadiad

Kheda
GUJARAT
387001
India 
Phone  9824727077  
Fax  2682520501  
Email  deandental@ddu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Hiren Patel 
Designation  Dean, Professor and Head Of Department. 
Affiliation  Faculty Of Dental Science, Dharmsinh Desai University. 
Address  Department Of Oral and Maxillofacial Surgery, Faculty Of Dental Science, Dharmsinh Desai University, College Road, Nadiad

Kheda
GUJARAT
387001
India 
Phone  9824727077  
Fax  2682520501  
Email  deandental@ddu.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Faculty Of Dental Science Dharmsinh Desai University 
Address  Faculty Of Dental Science, Dharmsinh Desai University, College Road, Nadiad, 387001. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Het Dave  Faculty of Dental Science, Dharmsinh Desai University.  Department Of Oral and Maxillofacial Surgery, Faculty Of Dental Science, Dharmsinh Desai University, College Road, Nadiad, 387001.
Kheda
GUJARAT 		 7405552000

Davehet000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE OF FACULTY OF DENTAL SCIENCE DHARMSINH DESAI UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K135||Oral submucous fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Seagull flap (modified nasolabial flap)  Seagull flap (modified nasolabial flap) will be used for surgical treatment in patients with grade III and grade IVa of oral submucous fibrosis. 
Comparator Agent  Standard nasolabial flap  Standard nasolabial flap will be used for surgical treatment in patients with grade III and grade IVa of oral submucous fibrosis. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Diagnosis of grade III and grade IVa stages of oral submucous fibrosis
2. Willingness to provide written informed consent to Participate in study
3. Good general health
 
 
ExclusionCriteria 
Details  1. Diagnosis of grade 0, grade I and grade II of oral submucous fibrosis
2. Patients with late and malignant form of oral submucous fibrosis grade IVb
3. Pregnant or lactating patient
4. Presence of active oral infection
5. Patients unable or unwilling to comply with postoperative care instructions 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mouth opening  Mouth opening of patients will be measured preoperatively, intraoperatively, 1 week after surgery, 1 month after surgery, 3 months after surgery and 6 months after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Flap acceptance  Flap acceptance will be evaluated 1 week after surgery. 
Donor site morbidity  Donor site morbidity will be evaluated 3 months after surgery. 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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)   25/02/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 study will assess the effectiveness of seagull flap (modified nasolabial flap) in comparision with standard nasolabial flap in surgical management of oral submucous fibrosis.  This study will evaluate and compare mouth opening, functional mobility and complications of seagull flap (modified nasolabial flap) and standard nasolabial flap while treating patients of oral submucous fibrosis. 

 
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