| CTRI Number |
CTRI/2024/05/068095 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| 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
|
Comparison of Rate of Healing of Skin of Mouth With Use of Buccal Fat Pad in Cleft Palate Patients |
|
Scientific Title of Study
|
Comparative Evaluation of Rate of Mucosalization of Residual Raw Areas Post Palatoplasty With Use of Buccal Fat Pad in Cleft Palate – A Randomised Controlled 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 |
Ritesh Chhatwani |
| Designation |
1st year MDS resident |
| Affiliation |
MGM Dental College and Hospital Kamothe NAVI MUMBAI |
| Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and
19 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
7972750268 |
| Fax |
|
| Email |
dr.riteshchhatwani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Adil Gandevivala |
| Designation |
Reader |
| Affiliation |
MGM Dental College and Hospital Kamothe |
| Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and
19 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9096815606 |
| Fax |
|
| Email |
dr.adilg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adil Gandevivala |
| Designation |
Reader |
| Affiliation |
MGM Dental College and Hospital Kamothe |
| Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and
19 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9096815606 |
| Fax |
|
| Email |
dr.adilg@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital
|
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hospital Kamothe navi mumbai |
| Address |
MGM Dental College and Hospital Kamothe 4th Floor Department of
Oral and Maxillofacial Surgery Plot No 1 and 2 Sector 01 Old 18 and
19 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ritesh Chhatwani |
MGM Dental Collage and Hospital |
MGM Dental College &
Hospital Kamothe 4th
Floor, Department of
Oral & Maxillofacial
Surgery, Plot No. 1 & 2,
Sector - 01(Old 18 &
19), Kamothe, Navi
Mumbai, 410209.
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA |
7972750268
dr.riteshchhatwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGM Dental College and Hospita |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q355||Cleft hard palate with cleft softpalate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1 GEL FOAM (ABgel) |
ABSORBABLE GELATIN SPONGE will be used to cover residual raw areas of palate and and follow up photographs will be taken on post operation day 7,day 14,day 16,day 18,day 20,day 22,day 24,day 26,day 28 to check for mucosalization and after 6 months to check for fistula formation |
| Intervention |
use of buccal fat pad to cover residual raw areas of palate post palatoplasty |
buccal fat pad will be used to cover residual raw areas of palate post palatoplasty and follow up photographs will be taken on post operation day 7,day 14,day 16,day 18,day 20,day 22,day 24,day 26,day 28 to check for mucosalization and after 6 months to check for fistula formation |
|
|
Inclusion Criteria
|
| Age From |
12.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants with cleft palate veau’s type I,II,III,IV
2) Participants under age group 12 months to 18 years of age requiring cleft palate surgery
3) Participants with parenteral consent upto 7 years of age, parenteral consent and assent from 7 years to 18 years of age willing to be part of study |
|
| ExclusionCriteria |
| Details |
1) Participants in which buccal fat pad has been previously used.
2) Participants having systemic bleeding disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| rate of mucosalization |
7th day, 14th day,16th day,18th day,20th day,22nd day,24th day,26th day,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of fistula formation |
6 months |
| incidence of bleeding |
0hr,3hrs,6hrs,12hrs,24hrs |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Palatoplasty
is surgery of cleft palate patients to reconstruct the altered intraoral
anatomy and achieve normal functions. Several surgical techniques have been
described for cleft palate, including von Langenbeck, Bardach’s and Furlow’s
techniques. The goal of the surgery is to restore normal anatomy, which helps
in feeding to prevent nasal regurgitation and prevention of articulation issues
secondary to the removal of air through the nose. The techniques used to close
the defect may result in bare bony areas on the hard palate after the elevation
of mucoperiosteal flaps and their subsequent medial mobilization. The defect
lateral to mucoperiosteal flaps closure is sometimes covered with sterile gauze
soaked with soft paraffin or tincture of benzoin or are left open for mucosalization
by means of secondary intention, which leads to discomfort to the patient. The defect usually heals by secondary
intention and scarring.
Buccal fat
pad is one of several encapsulated fat masses in cheek which is highly
vascularised and easy to harvest and may be used as flap.
Aim of this study is to evaluate the advantages
of using BFP as adjuvant to palatoplasty to cover residual raw area defects
created during palatoplasty. |