| CTRI Number |
CTRI/2024/12/078512 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study designed to compare if conventional vestibuloplasty is better to be done alone or in combination with PRF membrane to increase the ridge height and assess wound healing. |
|
Scientific Title of Study
|
Residual alveolar ridge height and wound healing after conventional vestibuloplasty
versus PRF membrane as an adjunct to conventional vestibuloplasty : A pilot
comparative clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25/2023 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muskan Gupta |
| Designation |
Post Graduate |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no. 9, Department of Periodontology, JSS Dental college and hospital, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
8930877425 |
| Fax |
|
| Email |
Aashigarg1204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash BS |
| Designation |
Reader |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no. 9, Department of Periodontology, JSS Dental college and hospital, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9945047223 |
| Fax |
|
| Email |
Dr.avinashbs@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avinash BS |
| Designation |
Reader |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no. 9, Department of Periodontology, JSS Dental college and hospital, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9945047223 |
| Fax |
|
| Email |
Dr.avinashbs@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| JSS Dental College and Hospital, Sri, Shivarathreeshwara Nagar, Bannimantap, Mysuru, Karnataka-570015 |
|
|
Primary Sponsor
|
| Name |
Dr. Muskan Gupta |
| Address |
Room no.9, Department of Periodontology, JSS Dental College and Hospital, Bannimantap, Mysuru, Karnataka-570015 |
| Type of Sponsor |
Other [Self] |
|
|
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 Muskan Gupta |
JSS Dental College and Hospital/ JSS Academy of Higher Education and Research |
Department of Periodontology, Room no.9, Mysuru, Karnataka
Mysore
KARNATAKA |
8930877425
Aashigarg1204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental college and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy, presenting with shallow depth of lower vestibule |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional vestibuloplasty |
A labial‑based mucosal supraperiosteal flap will be released from the underlying
periosteum through a horizontal incision at the mucogingival border, extending from the right to the left canine area. The flap will be then apically positioned and
resorbable periosteal sutures will be placed to the periosteum at the depth of newly created labial vestibule. |
| Intervention |
Conventional vestibuloplasty with PRF |
A labial‑based mucosal supraperiosteal flap was released from the underlying
periosteum through a horizontal incision of the mucogingival border, extending from the right to the left canine area. The flap was then apically positioned and resorbable periosteal sutures will be placed to the periosteum at the depth of newly created labial vestibule.
• Skin is cleaned with alcohol swabs and blood will be drawn with blood collector
needle 21 gauge.
• Blood will be collected in a 10 ml test- tube and will be subjected to centrifugation
at 2,700 rpm for 12 minutes.
• After which the tubes will be carefully taken out from the centrifuge and PRF
clots will be dehydrated in PRF box to obtain membranes.
• These membranes with the help of tissue forceps will be carefully sutured to the
wound site using resorbable sutures. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous mandibular arch.
Class III and class IV residual alveolar ridge height. |
|
| ExclusionCriteria |
| Details |
Systemic diseases, pregnancy and lactation.
Smoking, use of tobacco in any form and recreational drug users. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of PRF membrane as an adjunct to conventional vestibuloplasty in increasing the residual alveolar ridge height. |
Baseline, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate wound healing after conventional vestibuloplasty versus PRF
membrane as an adjunct to conventional vestibuloplasty. |
Baseline, 1 week |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| Date of Study Completion (India) |
28/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
- Removable dentures are a common treatment for optimal improvement in
function and esthetics in patients with edentulism. In subjects with high frenal
attachment or shallow depth of vestibule , pre-prosthetic surgeries like vestibuloplasty
and frenectomy play an imperative role in preparing the oral environment for a better
denture stability.
- Vestibuloplasty surgeries are usually performed to provide adequate depth in labial or
lingual vestibular area for denture flange.
- Several techniques for vestibuloplasty have been proposed such as conventional
vestibuloplasty, Kazanjian technique and lip-switch technique, grafting vestibuloplasty
with each one has its own advantages and disadvantages but the major disadvantage
being relapse of the vestibular depth to the original position.
- In 2000, platelet-rich fibrin (PRF) as the second generation of autologous platelet
concentrates (APCs) caught extreme attention for various oral application.
- PRF has no anti-coagulant agents and has excellent anti-bacterial , antiinflammatory , and regenerative potentials.
- To reduce the shortcomings of conventional vestibuloplasty procedures, PRF
membrane can be employed for covering the exposed area. Therefore, there would be
no need for further skin or mucosal graft harvesting; besides, the epithelialization rate
of the wound can be accelerated.
- The ease-of-applicability of this natural biomaterial can ultimately increase its
acceptance among surgeons and patients, while it leaves patients with less
complications after surgery.
The present study aims at comparing the residual rodge height and wound healing after conventional vestibuloplasty versus PRF membrane as an adjunct to conventional vestibuloplasty. |