| CTRI Number |
CTRI/2025/02/080254 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Surgical correction of Alveolar ridge defects: A Clinical study |
|
Scientific Title of Study
|
Augmentation of Localized Alveolar ridge defects using the Roll flap Technique: A Clinical 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 Mirali Daxini |
| Designation |
Resident Doctor |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Periodontics and Oral Implantology, Faculty of Dental Science, Dharmsinh Desai University, College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7046164001 |
| Fax |
|
| Email |
miralidaxini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasumati Patel |
| Designation |
Professor and Head of the Deparment |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Periodontics and Oral Implantology, Faculty of Dental Science, Dharmsinh Desai University, College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8200210769 |
| Fax |
|
| Email |
pateldrvasu@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mirali Daxini |
| Designation |
Resident Doctor |
| Affiliation |
Faculty of Dental Science, Dharmsinh Desai University |
| Address |
Department of Periodontics and Oral Implantology, Faculty of Dental Science Dharmsinh Desai University, College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7046164001 |
| Fax |
|
| Email |
miralidaxini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dharmsinh Desai University, Faculty of Dental Science, Nadiad, Gujarat |
|
|
Primary Sponsor
|
| Name |
Dharmsinh Desai University, Faculty of Dental Science, |
| Address |
Dharmsinh Desai University, Faculty of Dental Science, College road, Nadiad 387001, Gujarat |
| Type of Sponsor |
Research institution |
|
|
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 Mirali Daxini |
Faculty of Dental Science, Dharmsinh Desai University |
Department of Periodontics and Oral Implantology, Faculty of Dental Science, Dharmsinh Desai University, College road, Nadiad 387001
Kheda
GUJARAT |
7046164001
miralidaxini@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Roll Flap Technique |
Roll flap technique will be performed at baseline using horizontal or vertical partial-thickness incision at the alveolar ridge. This procedure will take 30-35 mins. The connective tissue beneath the flap is mobilized and rolled inward to the defect site. The flap is then repositioned and secured with sutures to enhance soft tissue volume and improve ridge contour. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with seibert ridge defects class 1,2 and 3
2.Patients with good oral hygiene with missing one or two tooth in the esthetic region
3.Patients with sufficient palatal connective tissue graft to accommodate ridge augmentation
4.Healing period following tooth extraction had to be at least 3 months prior to the surgical procedure |
|
| ExclusionCriteria |
| Details |
1.Patients with uncontrolled systemic diseases where surgery is contraindicated
2.Pregnant and lactating women
3.Smokers and tobacco users
4.Occlusal trauma at the site of the graft
5.Thin palatal donor site or scarring present |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in ridge contour and width after surgical procedure, measured through clinical assessment |
At baseline, Immediate,10 days,1 month,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aesthetically pleasing & patients acceptance |
At 6 months, 12 months, 18 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/02/2025 |
| 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="0"
Months="0"
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
|
This clinical study aims to evaluate the effectiveness of the roll flap technique for augmenting localized alveolar ridge defects. The procedure involves mobilizing a partial thickness flap of connective tissue, which is rolled inward to improve ridge contour and soft tissue volume. The primary outcome will be the improvement in ridge width and contour, assessed through clinical measurement and imaging. The study will also assess the safety and healing of the surgical site post procedure. This intervention is intended to provide better aesthetic and functional outcomes for individuals requiring ridge augmentation for dental prosthetics. |