| CTRI Number |
CTRI/2026/02/103463 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring the thickness of the soft tissue on the roof of the mouth and the finding safest area to take tissue using 3D X-ray (CBCT) |
|
Scientific Title of Study
|
Determination of palatal soft
tissue thickness and safe zone
for soft tissue harvest using
CBCT |
| 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 Vaishnavi Dilip Tarpe |
| Designation |
Post graduate student, Department of Oral medicine and Radiology |
| Affiliation |
Datta Meghe Institute Higher Education and Research |
| Address |
Department of Oral Medicine and Radiology, Room no. 001, Ground floor, SPDC Building, Sawangi Meghe.
Wardha
MAHARASHTRA
442001
India |
| Phone |
07758840081 |
| Fax |
|
| Email |
vaishnavitarpe97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suwarna Dangore Khasbage |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute Higher Education and Research |
| Address |
Department of Oral Medicine and Radiology, Room no. 001, Ground floor, SPDC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923024036 |
| Fax |
|
| Email |
hodomr.721@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suwarna Dangore Khasbage |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute Higher Education and Research |
| Address |
Department of Oral Medicine and Radiology, Room no. 001, Ground floor, SPDC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923024036 |
| Fax |
|
| Email |
hodomr.721@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and research, Sawangi Meghe, Wardha, Maharashtra, India
442001
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Vaishnavi Dilip Tarpe |
Sharad Pawar Dental College and Hospital |
Department of Oral Medicine and Radiology, Room no. 001, Ground floor, SPDC Building, Sawangi Meghe
Wardha
MAHARASHTRA |
07758840081
vaishnavitarpe97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K13||Other diseases of lip and oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Bilateral presence of teeth from the canine to second molar.
2. Images taken for either implant surgery or orthodontic treatment purposes
|
|
| ExclusionCriteria |
| Details |
1. Radiographic evidence of surgery, fracture, congenital anomalies of palate.
2. Radiographic evidence of missing teeth, metallic restoration, severe crowding, local pathology, rotation of tooth, spacing in the maxilla
3. Radiographs with tongue interference or soft tissue occlusion in the region of interest
4.Radiographs with any other developmental tooth anomalies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CBCT can be useful method for assessment of palatal soft tissue thickness and safe zone for palatal soft tissue harvest |
Assessment will be done at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/02/2026 |
| 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="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
|
Palatal soft tissue harvesting procedures
are routinely performed in periodontal and peri-implant plastic procedures. Different soft tissue graft harvesting approaches have been proposed. The soft
tissue graft is considered the material of choice in treating gingival or
mucosal recessions around teeth and implants because it provides an increased
marginal soft tissue thickness, protects postsurgical healing by the first
intention and maintains the innate tissue texture as of adjacent teeth or
implants. Nonetheless, the location of the donor site can affect the graft
shape and its composition. This will be a retrospective study to determine
palatal soft tissue thickness and safe zone for palatal soft tissue harvest
using CBCT.
|