CTRI

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CTRI Number

CTRI/2026/01/101156 [Registered on: 14/01/2026] Trial Registered Prospectively

Last Modified On:

24/04/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparative Study Between Radial Forearm Free Flap[RAFF] And Pectoralis Major Myocutaneous Pedicle Flap[PMMF] In Maxillofacial Oncologic Surgical Defects A RANDOMISED CONTROL TRIAL

Scientific Title of Study

Comparision of Radial Forearm Free Flap and Pectoralis Major Myocutaneous Pedicle Flap in maxillofacial oncologiacl defect in view of esthetics, functional outcome,feeding tube dependency ,mouth opening and quality of life post surgery A randomised control

Trial Acronym

NILL

Secondary IDs if Any

Secondary ID	Identifier
NILL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Upasa Sarma Medhi
Designation	Post Graduate Trainee
Affiliation	INSTITUTE OF DENTAL SCIENCES, SIKSHA O ANUSANDHAN
Address	Institute of dental sciences, bhubaneswar K8, KALINGA NAGAR, BHUBANESWAR, ORISSA Khordha ORISSA 751003 India
Phone	7086046827
Fax
Email	upasa1234@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Subrat Padhiary
Designation	Professor
Affiliation	INSTITUTE OF DENTAL SCIENCES, SIKSHA O ANUSANDHAN
Address	Institute of dental sciences, bhubaneswar K8, KALINGA NAGAR, BHUBANESWAR, ORISSA Khordha ORISSA 751003 India
Phone	7086046827
Fax
Email	subratpadhiary@soa.ac.in

Details of Contact Person
Public Query

Name	Dr Upasa Sarma Medhi
Designation	Post Graduate Trainee
Affiliation	INSTITUTE OF DENTAL SCIENCES, SIKSHA O ANUSANDHAN
Address	Institute of dental sciences, bhubaneswar K8, KALINGA NAGAR, BHUBANESWAR, ORISSA Khordha ORISSA 751003 India
Phone	7086046827
Fax
Email	upasa1234@gmail.com

Source of Monetary or Material Support

department of oral and maxillofacial surgery,Institute of dental sciences, bhubaneswar

Primary Sponsor

Name	SIKSHA O ANUSANDHAN
Address	K8, KALINGA NAGAR, BHUBANESWAR,751003,Odisha,India
Type of Sponsor	Private medical college

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 Upasa Sarma Medhi	INSTITUTE OF DENTAL SCIENCES	department of oral and maxillofacial surgery, room number 3, institute of dental sciences, K8 , KALINGA NAGAR,BHBANESWAR,751003 Khordha ORISSA	7086046827 upasa1234@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTE OF DENTAL SCIENCES	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C148\|\|Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Pectoralis Major Myocutaneous Flap (PMMF)-GROUP B	Participants allocated to this group will undergo reconstruction of the maxillofacial defect using a pectoralis major myocutaneous flap following oncologic resection. The flap will be raised as a pedicled flap based on the thoracoacromial vascular pedicle and inset into the defect according to standard surgical technique. Donor site closure will be performed as per standard institutional protocol.
Intervention	RADIAL FORE-ARM FREE FLAP RECONSTRUCTION.-GROUP A	Participants allocated to this group will undergo reconstruction of the maxillofacial defect using a radial forearm free flap following oncologic resection. The flap will be harvested from the forearm with its vascular pedicle and microvascular anastomosis will be performed to suitable recipient vessels in the neck. Donor site closure will be done as per standard institutional protocol

Inclusion Criteria

Age From	20.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	patient with oral squamous cell carcinoma proven by biopsy, planned for single stage resection and soft tissue flap reconstruction

ExclusionCriteria

Details

-Patients not available for complete follow-up during the postoperative assessment period.
-Patients with collagen disorders and haematological disorders.
-Negative Allens test (for case of RFAFF cases only)
-Patients with history of previous surgery, radiation or chemotherapy in head and neck region.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
to examine donor site complications ,esthetics and functional outcome and quality of life	1 month,3 month and 6 month post operatively

Secondary Outcome

Outcome	TimePoints
Functional outcomes -Speech (using an assessment scale) -Swallowing (Mann Assessment of Swallowing Ability–Oral Cancer [MASA-C]) -Feeding tube dependence Esthetic outcome (measured by POSAS Patient Scale) Donor site complications (POSAS Observer Scale)	30 days,60days,90 days

Target Sample Size

Total Sample Size="36"
Sample Size from India="36"
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)

13/02/2026

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="1"
Months="3"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

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 - YES

What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiﬁcation.

What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiﬁed for this purpose.

For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.

By what mechanism will data be made available?
Response - Proposals should be directed to [upasa1234@gmail.com].

For how long will this data be available start date provided 30-01-2026 and end date provided 07-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

this is a prospective, randomized, parallel-group, active-controlled clinical trial conducted to compare the outcomes of Radial Forearm Free Flap and Pectoralis Major Myocutaneous Flap for reconstruction of maxillofacial oncologic defects. A total of 36 patients will be randomly allocated in a 1:1 ratio to either reconstruction technique using computer-generated randomization with sealed opaque envelope allocation. Blinding will be applied to the outcome assessor and investigator. The primary outcome will be flap survival, defined as complete viability of the reconstructive flap without total flap loss within 30 days, 60 days and 90days postoperatively. Secondary outcomes include postoperative complications, feeding tube dependency, swallowing assessment ,speech, mouth opening, esthetic outcome, and donor site morbidity. Outcome assessment will be performed intraoperatively, during the immediate postoperative period, at 30 days,60 days,90 days interval postoperatively.