| CTRI Number |
CTRI/2026/01/101565 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
In patients planned for dental implant treatment, we will evaluate the effectiveness of improving gum tissues around dental implants in maintaining implant health and longevity and compare two materials for the same, a laboratory developed tissue substitute vs tissue taken from patients own mouth |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of soft tissue augmentation around implants with tissue-engineered scaffold versus autogenous sub-epithelial connective tissue graft – a randomized controlled 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 Ashutosh Srivastava |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences, King Georges Medical University |
| Address |
Room number 14,
Department of Periodontology,
5th floor, New Dental Building,
Faculty of Dental Sciences,
King Georges Medical University,
Chowk, Lucknow,
Uttar Pradesh.
Room number 14,
Department of Periodontology,
5th floor, New Dental Building,
Faculty of Dental Sciences,
King Georges Medical University,
Chowk, Lucknow,
Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9793964921 |
| Fax |
|
| Email |
sashutosh539@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rameshwari Singhal |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, King Georges Medical University |
| Address |
Department of Periodontology,
5th floor, New Dental Building,
Faculty of Dental Sciences
King Georges Medical University,
Chowk, Lucknow.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9837400562 |
| Fax |
|
| Email |
rameshwarisinghal@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rameshwari Singhal |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, King Georges Medical University |
| Address |
Department of Periodontology,
5th floor, New Dental Building,
Faculty of Dental Sciences
King Georges Medical University,
Chowk, Lucknow.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9837400562 |
| Fax |
|
| Email |
rameshwarisinghal@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashutosh Srivastava |
Room number 14, Department of Periodontology |
Room number 14,
Department of Periodontology,
5th floor, New Dental Building,
Faculty of Dental Sciences,
King Georges Medical University
Lucknow
UTTAR PRADESH |
9793964921
sashutosh539@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University, U.P., Institutional Ethics Committee, Lucknow - 226003 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers requiring dental prosthetic rehabilitation with dental implants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dental implant without any intervention |
Dental implant will be placed at the required site and patient will be under follow up for 3 months for monitoring proper healing and osseointegration of implant. |
| Intervention |
Soft tissue augmentation using sub-epithelial connective tissue graft |
Dental implant will be placed at the required site and deficient soft tissue will be augmented using autologous connective tissue graft harvested from patients own palate. The connective tissue graft will be sutured between the bone and soft tissue flap using resorbable sutures and then the flap will be closed or approximated using non resorbable sutures. Patients will be called after 1 week for non resorbable suture removal and will be under follow up for 3 months for monitoring proper healing of peri implant soft tissues and osseointegration of implant. |
| Intervention |
Soft-tissue augmentation using tissue-engineered scaffold and FGF-2 |
Dental implant will be placed at the required site and deficient soft tissue will be augmented using tissue engineered scaffold made using gel methacrylate along with fibroblast growth factor 2. The tissue engineered scaffold incorporated with FGF2 will be sutured between the bone and soft tissue flap using resorbable sutures and then the flap will be closed or approximated using non resorbable sutures. Patients will be called after 1 week for non resorbable suture removal and will be under follow up for 3 months for monitoring proper healing of peri implant soft tissues and osseointegration of implant. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults between 18-60 years of age.
2. Patients planned for dental implant placement.
3. Full mouth plaque scores (FMPS) and full mouth bleeding scores (FMBS) less than 20 percent after non-surgical periodontal therapy.
4. Non-smokers or former smokers (not smoked within 6 months of study initiation).
5. Ability to comply with the study-related procedures, such as exercising good oral hygiene and attending all follow-up examinations.
6. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients with clinically significant or unstable systemic diseases or compromised healing potential (i.e. connective tissue disorders or bone metabolic diseases).
2. Patients with history of antibiotic, non-steroidal anti-inflammatory medication or on drug affecting periodontal status for greater or equal to two weeks prior to enrolment in the study.
3. Pregnant or lactating women.
4. History of periodontal surgery within the last one year of enrolment. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of soft tissue augmentation in improving and/or maintaining peri-implant health (gain in thickness of peri-implant soft tissue and gain in width of attached gingiva) and esthetics (using Pink Esthetic Score). |
Width of attached gingiva and thickness of peri-implant soft-tissue - baseline (T0), after 1 month (T1), after 3 months (T2).
Esthetics of peri-implant soft-tissue (Pink Esthetic Score) - baseline (T0) and after 3 months (T2). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effects of tissue-engineered scaffold with FGF-2 in improving and/or maintaining peri-implant health (gain in thickness of peri-implant soft tissue and gain in width of attached gingiva) and esthetics (using Pink Esthetic Score) with those of conventional sub-epithelial connective tissue graft. |
Width of attached gingiva and thickness of peri-implant soft-tissue - baseline (T0), after 1 month (T1), after 3 months (T2).
Esthetics of peri-implant soft-tissue (Pink Esthetic Score) - baseline (T0) and after 3 months (T2). |
| Patient perceived satisfaction and cost effectiveness of tissue engineering scaffold with FGF-2 in comparison to sub-epithelial connective tissue graft. |
After 3 months (questionnaire based) |
|
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Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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 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 - NO
|
|
Brief Summary
|
Dental implants are a predictable option for restoring edentulous or partially edentulous patients, but tooth-borne pathology often results in horizontal or vertical bone defects and inadequate soft tissue at implant sites. Mucogingival surgery is frequently used to improve the quality and quantity of peri-implant soft tissue, supporting peri implant health, esthetics, and patient comfort during oral hygiene.
Soft tissue augmentation serves two main objectives 1. Increasing the width of attached keratinized mucosa to facilitate hygiene 2. Increasing soft tissue volume to create a favorable, convex peri-implant mucosal contour. These procedures are associated with improved short and long term biological, functional, and esthetic outcomes. Augmentation may also help maintain marginal bone levels by improving the soft tissue seal around implants.
Autogenous subepithelial connective tissue grafts remain the gold standard for augmenting soft tissue volume, but they present disadvantages such as anatomical limitations in graft size and donor site morbidity, including postoperative pain and numbness. To reduce these issues, alternative soft tissue substitutes have been developed. One such emerging option is a tissue-engineered scaffold incorporating fibroblast growth factor (FGF2).
This study aims to evaluate the benefits of soft tissue augmentation at implant sites and to compare the effectiveness of an FGF2 enhanced tissue engineered scaffold with that of autogenous grafts for peri implant soft tissue augmentation.
Primary outcome To determine the efficacy of soft tissue augmentation in improving and or maintaining peri implant health (thickness of peri implant soft tissue and width of attached gingiva on baseline T0, after 1 month T1, and after 3 months T2) and esthetics (Pink Esthetic Score at baseline T0 and after 3 months T2).
Secondary outcomes 1. To evaluate and compare the effects of tissue engineered scaffold with FGF2 on peri implant health (thickness of peri implant soft tissue and width of attached gingiva on baseline T0, after 1 month T1, and after 3 months T2) and esthetics (Pink Esthetic Score at baseline T0 and after 3 months T2) with those of conventional subepithelial connective tissue graft 2. To determine the patient perceived satisfaction and cost effectiveness of tissue engineering scaffold with FGF2 in comparison to sub epithelial connective tissue graft (questionnaire based).
Control group Dental implant placement without any soft tissue augmentation procedure
Test group 1 Dental implant placement with soft tissue augmentation using autogenous subepithelial connective tissue graft.
Test group 2 Dental implant placement with soft tissue augmentation using tissue engineered scaffold incorporated with FGF2.
The patients will then be asked to report for regular follow ups to monitor proper healing of the surgical sites(s) and for recording of clinical parameters. |