| CTRI Number |
CTRI/2025/01/079228 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Changes in soft tissue around dental implant with two techniques autogenous graft and xenogenic membrane |
|
Scientific Title of Study
|
Evaluation of the soft tissue outcomes following keratinized tissue augmentation around dental implant using two different techniques free gingival graft and Xenogenic 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 Deepali Engla |
| Designation |
Pg student |
| Affiliation |
Government College of Dentistry Indore |
| Address |
Room No.10, Department of Periodontology Government College of Dentistry, Indore Opposite M Y Hospital, Sardar Patel Marg Indore, Madhya Pradesh
Indore
MADHYA PRADESH
452001
India |
| Phone |
9926801969 |
| Fax |
|
| Email |
deepaliengla1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu S Ratre |
| Designation |
Professor and Head |
| Affiliation |
Government College of Dentistry Indore |
| Address |
Room No.10, Department of Periodontology Government College of Dentistry, Indore Opposite M Y Hospital, Sardar Patel Marg Indore, Madhya Pradesh
Indore
MADHYA PRADESH
452001
India |
| Phone |
9406928976 |
| Fax |
|
| Email |
smadhu16feb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Engla |
| Designation |
Pg student |
| Affiliation |
Government College of Dentistry ,Indore |
| Address |
Room No.10, Department of Periodontology Government College of Dentistry, Indore Opposite M Y Hospital, Sardar Patel Marg Indore, Madhya Pradesh
Indore
MADHYA PRADESH
452001
India |
| Phone |
99268010969 |
| Fax |
|
| Email |
deepaliengla1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government College of Dentistry Indore Room Number 10 Department Oof Periodonlogy Government College of Dentistry ,Indore Opposote M Y Hospital Sardar Patel Marg Indore |
|
|
Primary Sponsor
|
| Name |
Government College of Dentistry Indore |
| Address |
Room No 10 Department of Periodontology Government COllege of Dentistry Indore Opposite M Y Hospital Sardar Patel Marg Indore 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 Deepali Engla |
Government College of Dentistry Indore |
Room No 10 Department of Periodontology Government College of Dentistry Indore Opposite MY Hospital Sardar Patel Marg, Indore
Indore
MADHYA PRADESH |
9926801969
deepaliengla1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. College of Dentistry,Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, (3) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Free gingival graft and xenogenic collagen matrix
|
To evaluate the effectiveness of collagen matrix (CM) grafts in increasing the zone of keratinized tissue (KT) around dental implants and to evaluate and compare the outcome in soft tissue thickness of augmented tissue (AT) around dental implants using FGG and CM at baseline, (T1)02 month and (T2)04 month.
|
| Intervention |
Keratinized tissue augmentation
around dental implant |
To evaluate the effectiveness of collagen matrix (CM) grafts in increasing the zone of keratinized tissue (KT) around dental implant and and to evaluate and compare the outcome in soft tissue thickness of augmented tissue (AT) around dental implant using FGG AND CM at baseline, (T1)02 month and(T2)04 month.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with systemic diseases such as diabetes mellitus, hypertension or conditions that alters the outcome of periodontal therapy (e.g. HIV, Hepatitis).
Patient showing active infection in mouth.
Pregnant and lactating women.
Psychiatric illness.
Implants will be excluded if they present with complications during the course of study that required additional treatments.
|
|
| ExclusionCriteria |
| Details |
Patients With Systemic Disease Such as Diabetes Mellitus, Hypertion or conditions that alters the outcome of Periodontal Therapy (E.G. HIV, Hepatitis).
Patients Showing active infection in mouth.
Pregnant and Lactating women.
Psychiatric Illness.
Implants will be excluded if they present with complication during the course of study that required additional treatments.
|
|
|
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 effectiveness of Collagen Matrix (CM) grafts in increasing the zone of keratinized tissue (KT) around dental implants |
BASELINE,02MONTHS, 04MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the outcome in soft tissue thickness of augmented tissue (at) around dental implants using FGG and CM. |
BASELINE,02MONTHS, 04MONTHS |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| 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="4"
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-identiļ¬cation.
- 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) - PUBLICATION
- For how long will this data be available start date provided 12-02-2025 and end date provided 02-12-2026?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background
An adequate zone of keratinized tissue (KT) and soft tissue thickness (STT) around dental implants is vital for peri-implant health and aesthetics. Collagen matrix (CM) grafts offer a less invasive alternative to free gingival grafts (FGG). Purpose
To evaluate the effectiveness of CM grafts in increasing KT and compare their outcomes with FGG in improving soft tissue thickness around dental implants. |