| CTRI Number |
CTRI/2025/04/084568 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Peri-implant Mucosal Enhancement Using Concentrated Growth Factor Membrane at Different Stages of Implant Placement: An Interventional Study |
|
Scientific Title of Study
|
Comparative evaluation of peri-implant mucosal enhancement with and without concentrated growth factor membrane at different stages of implant placement – an interventional 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 Shyamesh Pareekh |
| Designation |
|
| Affiliation |
A.J. Institute of dental sciences |
| Address |
Department of periodontology, A.J. Institute of dental sciences, Kuntikana, Mangalore.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9110415501 |
| Fax |
|
| Email |
shyampareekh12345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARIMALA KUMAR |
| Designation |
READER |
| Affiliation |
A.J. Institute of dental sciences |
| Address |
Department of periodontology, A.J. Institute of dental sciences, Kuntikana, Mangalore.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9448915650 |
| Fax |
|
| Email |
parikodgi76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parimala Kumar |
| Designation |
Reader |
| Affiliation |
A.J. Institute of dental sciences |
| Address |
Department of periodontology, A.J. Institute of dental sciences, Kuntikana, Mangalore.
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9448915650 |
| Fax |
|
| Email |
parikodgi76@gmail.com |
|
|
Source of Monetary or Material Support
|
| A.J. Institute of dental sciences, Department of periodontology, A.J. Institute of dental sciences, Kuntikana, Mangalore, 575004 |
|
|
Primary Sponsor
|
| Name |
Dr Shyamesh Pareekh |
| Address |
A.J. Institute of dental sciences, Department of periodontology, A.J. Institute of dental sciences, Kuntikana, Mangalore, 575004 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Parimala Laxmish Kumar |
A.J. INSTITUTE OF DENTAL SCIENCES |
Department of periodontology, Room no. 03, A.J. Institute of dental sciences, Kuntikana, Mangalore, 575004
Dakshina Kannada
KARNATAKA |
9448915650
parikodgi76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AJIDS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers with missing teeth in lower posterior tooth region |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 - Control Group |
1. Stage 1 Surgery (Implant Placement):
Standard surgical protocol is followed for implant placement.
A mid-crestal incision is made, and a full-thickness flap is elevated to expose the
alveolar bone.
The implant site is prepared using sequential drills according to BioHorizons implant system guidelines.
The implant is placed in the prepared osteotomy.
The flap is repositioned and sutured to achieve primary closure.
No use of CGF or additional biomaterials.
2. Stage 2 Surgery (Abutment Connection):
After an appropriate healing period (usually 3–4 months), a minor incision is made to expose the implant.
The healing abutment is connected.
No CGF application during this stage. |
| Intervention |
GROUP 2 |
CGF Placed On The Day Of Implant Placement
1.Stage 1 Surgery:
Same surgical protocol as the control group is followed up to implant placement.
After implant is placed, CGF membranes were prepared and placed over the implant site.
The flap is repositioned and sutured to achieve primary closure.
2. Stage 2 Surgery - Abutment Connection:
After an appropriate healing period (usually 3–4 months), a minor incision is made to expose the implant.
The healing abutment is connected.
No CGF application during this stage.
|
| Intervention |
GROUP 3 |
CGF At Stage 2 With Gingival Former Placement (Sohn’s Poncho Technique)
1. Stage 1 Surgery:
The same surgical protocol as the control group is followed.
Implant placement is completed, and the flap is repositioned and sutured to achieve primary closure.
No CGF is applied during Stage 1 surgery.
2.Stage 2 Surgery:
After the healing period (usually 3–4 months), a minor incision is made to expose the implant.
A gingival former is connected to the implant.
CGF membrane is prepared and shaped into a "poncho" to fit around the gingival former.
The CGF poncho is draped around the gingival former and surrounding mucosa.
Flap is sutured around the gingival former, securing the CGF in place.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Systemically healthy patients with no history of uncontrolled medical conditions (e.g., uncontrolled diabetes, cardiovascular disease).
2) Participants aged 18-65 years.
3) Need for one or more dental implants in the mandibular posterior region.
4) Participants with peri-implant mucosal thickness of 1.5mm – 2.5mm.
5) Participants with NO ongoing periodontal disease.
6) Presence of stable occlusion(bite).
7) Sufficient bone volume and quality to support the implant based on radiographs.
8) Ability to understand and comply with study procedures, including follow-up visits
|
|
| ExclusionCriteria |
| Details |
1) Participants with uncontrolled systemic conditions, such as uncontrolled diabetes, cardiovascular diseases, autoimmune disorders, or bleeding disorders.
2) Severe bone loss - Insufficient bone width or height for implant placement or presence of advanced bone atrophy.
3) Use of medications like systemic corticosteroids, immunosuppressants, or bisphosphonates that could impair healing or affect CGF efficacy.
4) History of radiotherapy in the head/neck area or chemotherapy within the last 12 months.
5) Participants who are unable to follow post-operative care instructions or attend follow-up visits.
6) Any ongoing periodontal infection.
7) Pregnant or breastfeeding women.
8) Known allergies to materials used in implant dentistry.
9) Previous implant failures or complications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Thickness of Peri-Implant Mucosa |
Baseline, 4 Weeks and 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Width of Keratinized Tissue
2. Healing Progression
|
Baseline, 4 Weeks & 3 Months |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
14/05/2025 |
| 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="11"
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
|
SUMMARY:Rationale/gaps in existing knowledge: The long-term success of dental implants is significantly influenced by the thickness of the peri-implant mucosa. Inadequate mucosal thickness can predispose the implant site to complications such as peri-implantitis and compromise aesthetic outcomes. While Concentrated Growth Factors (CGF) have demonstrated regenerative properties in various dental procedures, their specific role in enhancing peri-implant mucosal thickness at different stages of implant placement has not been thoroughly investigated, indicating a gap in current clinical knowledge. Novelty: This study introduces a novel approach by evaluating the effectiveness of a CGF membrane in improving both peri-implant mucosal thickness and the width of keratinized mucosa. It also uniquely compares the impact of CGF application when administered at different stages of implant placement, thereby aiming to identify the most beneficial timing for CGF use. Objectives: The study aims to assess and compare clinical parameters, specifically mucosal thickness and the width of keratinized mucosa, among three distinct groups at baseline, four weeks, and three months. The objective is to evaluate the changes and improvements in these parameters over time following CGF application. Methods: This is an interventional clinical study involving three groups. The first group serves as the control, receiving no CGF application. The second group receives CGF at the time of Stage 1 implant placement, while the third group receives CGF during Stage 2 implant placement. Measurements of peri-implant mucosal thickness and width of keratinized mucosa will be recorded at baseline, four weeks, and three months to monitor the progression and effects of the intervention. Expected outcome: It is anticipated that the application of CGF will lead to a measurable enhancement in peri-implant mucosal thickness, with one particular stage of application showing superior outcomes. The findings are expected to offer valuable insights into the optimal timing of CGF application for improving peri-implant soft tissue outcomes. |