| CTRI Number |
CTRI/2025/02/081314 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare the vertical soft tissue gain following augmentation using subepithelial connective tissue graft vs volume stable collagen matrix with simultaneous dental implant placement |
|
Scientific Title of Study
|
Evaluation of the crestal soft tissue thickness and crestal bone level changes following vertical soft tissue augmentation with dental implant using subepithelial connective tissue graft and volume stable collagen matrix – a randomized 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. Neha Patle |
| Designation |
PG student |
| Affiliation |
Government College of Dentistry Indore |
| Address |
Room no 10 2nd floor Government College of Dentistry Indore Madhya Pradesh 452001
Department of Periodontology Government College of Dentistry Indore Madhya Pradesh 452001
Indore
MADHYA PRADESH
452001
India |
| Phone |
9284250216 |
| Fax |
|
| Email |
nehapatle43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Madhu S. Ratre |
| Designation |
Professor and Head Department of Periodontology Government College of Dentistry Indore |
| Affiliation |
Government College of Dentistry Indore |
| Address |
Room no 10 second floor Government College of Dentistry Indore
Department of Periodontology Government College of Dentistry Indore Opposite to MY hospital Indore Madhya Pradesh
Indore
MADHYA PRADESH
452001
India |
| Phone |
9406928976 |
| Fax |
|
| Email |
smadhu16feb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Patle |
| Designation |
PG Student |
| Affiliation |
Government College of Dentistry Indore |
| Address |
Room no 10 Government College of Dentistry opposite to MY hospital Indore Madhya Pradesh
Department of Periodontology Government College of Dentistry Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9284250216 |
| Fax |
|
| Email |
nehapatle43@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology Government College of Dentistry Indore opposite MY hospital Indore Madhya Pradesh 452001 India |
|
|
Primary Sponsor
|
| Name |
Government College of Dentistry Indore |
| Address |
Government College of Dentistry Indore Opposite to MY hospital sardar patel marg Indore Madhya Pradesh India 452001 |
| Type of Sponsor |
Government 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 Neha Patle |
Government College of Dentistry Indore |
Department of Periodontology Room no 10 opposite to MY hospital Indore Madhya Pradesh
Indore
MADHYA PRADESH |
9284250216
nehapatle43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government College of Dentistry, Indore |
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, (2) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Augmentation of vertical soft tissue thickness simultaneous with dental implant placement |
To evaluate and compare the efficacy of autogenous subepithelial connective tissue graft to volume stable collagen matrix in increasing vertical soft tissue thickness around dental implants clinically and radiographically at baseline (VT0) and after 4 months (VT1) and to evaluate the crestal bone level changes radiographically at baseline (T0) and after 4 months (T1) |
| Comparator Agent |
Group 1 subepithelial connective tissue graft
Group 2 xenogenic volume stable collagen matrix |
To compare the efficacy of autogenous subepithelial connective tissue graft to volume stable collagen matrix in increasing vertical soft tissue thickness around dental implants clinically and crestal bone level changes radiographically |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)systemically healthy patients aged from 20 years to 50 years
2)Localised edentulous site with adjacent healthy teeth to be present
3)Patients with thin crestal mucosal thickness i.e. less than 3mm covering edentulous alveolar ridge
4)Minimum 6mm of edentulous osseous ridge dimension so no hard tissue augmentation is required
5)Patient willing to paticipate in the study ready to give written consent and regular follow up |
|
| ExclusionCriteria |
| Details |
1)No bone augmentation procedures before and during implant placement.
2)Any complications during implant placement which require advanced bone regenerative procedures.
3)Patients with history of any allergy.
4)Systemic diseases such as diabetes mellitus, hypertension or conditions that alters the outcome of periodontal therapy (e.g. HIV, Hepatitis).
5)Patient showing active infection in mouth.
6)Pregnant and lactating women.
7)Psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the crestal soft tissue thickness following vertical soft tissue augmentation with dental implant using subepithelial connective tissue graft and volume stable collagen matrix |
1)VT0 at baseline
2)VT1 after 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the crestal bone level changes following vertical soft tissue augmentation with dental implant using subepithelial connective tissue graft & volume stable collagen matrix |
1)T0 at baseline
2)after 4 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - 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 - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 07-03-2025 and end date provided 10-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Comparison of vertical soft tissue gain and crestal bone level changes following crestal soft tissue augmentation using autogenous subepithelial connective tissue graft and xenogenic volume stable collagen matrix |