| CTRI Number |
CTRI/2025/04/084503 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enhancing Peri-Implant Soft Tissue: A Study on Porcine-Derived Acellular Dermal Matrix |
|
Scientific Title of Study
|
“Comparative evaluation of the peri-implant soft tissue phenotype with and without the use of porcine-derived acellular dermal matrix” – A randomised control trial. |
| 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 CHANDAN TM |
| Designation |
Postgraduate student |
| Affiliation |
A.J Institute of Dental Sciences. |
| Address |
Department of periodontics and implantology, room number 3 , AJ institute of dental sciences NH66 kuntikan manglore karnataka
AJ institute of dental sciences NH66 kuntikan manglore karnataka
Dakshina Kannada
KARNATAKA
575013
India |
| Phone |
9663514067 |
| Fax |
|
| Email |
chandantm31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NANDINI MANJUNATH |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
A.J Institute of Dental Sciences. |
| Address |
Department of periodontics and implantology, room number 3, AJ institute of dental sciences NH66 kuntikan manglore karnataka
AJ institute of dental sciences NH66 kuntikan manglore karnataka
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9845314069 |
| Fax |
|
| Email |
nandinimanjunath747@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NANDINI MANJUNATH |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
A.J Institute of Dental Sciences. |
| Address |
Department of periodontics and implantology, room number 3, AJ institute of dental sciences NH66 kuntikan manglore karnataka
AJ institute of dental sciences NH66 kuntikan manglore karnataka
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9845314069 |
| Fax |
|
| Email |
nandinimanjunath747@gmail.com |
|
|
Source of Monetary or Material Support
|
| A.J INSTITUTE OF DENTAL SCIENCES MANGLORE, karnataka India. 575004. |
|
|
Primary Sponsor
|
| Name |
chandan |
| Address |
deadend vivekananda nagara kodikal main road manglore, karnataka - 575013 |
| 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 NANDINI MANJUNATH |
Department of periodontics and implantology, AJ institute of dental scienses. |
Department of periodontics and implantology, room number 3, AJ institute of dental sciences NH66 kuntikan manglore 575004
Dakshina Kannada
KARNATAKA |
9845314069
nandinimanjunath747@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 |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACELLULAR DERMAL MATRIX |
Following local anesthesia, a mid-crestal incision is made, and full-thickness mucoperiosteal flaps are reflected to expose the bone. After osteotomy, the implant and healing abutment are placed, followed by the application of acellular dermal matrix. The flaps are then closed and secured with sutures. Frequency of application of acellular dermal matrix in once during the surgery. |
| Comparator Agent |
conventional |
Following local anesthesia, a mid-crestal incision is made, and full-thickness mucoperiosteal flaps are reflected to expose the bone. After osteotomy, the implant and healing abutment are placed, The flaps are then closed and secured with sutures. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.periodontaly healthy or with stable treated periodontitis and good oral hygiene(full mouth plaque score and full mouth bleeding score less than or equal to 10%)
2. need for one or two implants in the posterior region (maximum of three missing teeth).
3. enough bone avilability to place an implant with a minimum diameter of 3.8 to 4.2 mm and atleast 10mm length.
4. non-smoker.
5. ability to understand the study procedures and to comply with them to the entire length of the study. |
|
| ExclusionCriteria |
| Details |
1.subjectes taking medications with immunosuppressors, bisphosphonates or high doses of corticosteroids; current drug or alcohol use or dependence that could interfere with adherence to study requirements.
2.pregnant or lactating women.
3.history of cancer requiring radiotherapy or chemotherapy during the last 5 years.
4.local inflammation (including untreated periodontitis)
5.severe bruxism or clenching habits.
6.any kind of bone augmentation performed on the implant site, with a healing period less than 6 months.
7.lack of primary implant stability assessed intra surgically. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increased peri-implant soft tissue thickness and width of keratinized mucosa |
baseline, 1month, 3months, 6months, 9months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved peri-implant soft tissue health and aesthetics. also longevity of implant |
baseline, 1month, 3months, 6months, 9months. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
01/05/2025 |
| 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
|
Dental implants are a reliable long-term solution for tooth replacement, with survival rates exceeding 95% over ten years (1). Beyond function, implants play a crucial role in preserving bone and soft tissue integrity. Achieving aesthetic and functional success requires proper implant positioning and meticulous soft tissue management, as emphasized by Dr. Dennis Tarnow: “The best implant is the one that looks like it was never placed.” While peri-implant bone stability is well-documented, Emerging evidence highlights the importance of soft tissue thickness in implant longevity (2). Berglundh and Lindhe demonstrated that adequate soft tissue thickness is necessary for forming biological structures akin to natural teeth. Linkevicius et. al found that an alveolar mucosa thickness >2 mm significantly reduces peri-implant bone loss within the first year (3-4). Insufficient keratinized mucosa (<2 mm) is associated with increased probing depth, bleeding, and plaque accumulation, whereas adequate keratinized mucosa enhances plaque control and peri-implant health. (5-10) | Traditional augmentation techniques like subepithelial connective tissue grafts (SCTG) and free gingival grafts (FGG) are effective but pose challenges such as patient morbidity and donor site limitations (11-14). As an alternative to SCTG, the porcine acellular dermal matrix, composed of collagen types I and III, has been proposed. Studies have demonstrated its excellent biodegradation properties within the surrounding tissues. | Acellular Dermal Matrix (ADM), is a widely used xenograft material that supports revascularization, cell repopulation, and tissue remodelling. Its advantages include an unlimited supply, the elimination of the need for a secondary palatal surgical site and decreased intraoperative time. ADM facilitates soft tissue augmentation by providing an extracellular matrix that promotes cellular migration and revascularization. Studies suggest ADM can mimic the native tissue microenvironment and provide structural stability. Clinical trials have shown that ADM achieves comparable outcomes to Connective Tissue Grafts (CTG) in root coverage and reducing recession depth and width. It has been successfully applied to enhance natural soft tissue around teeth. (15-18). The present study will be comparing peri-implant soft tissue phenotype with and without ADM. Patients will be randomly assigned to a control group (Group I- implant with healing abutment) and a test group (Group II-Implant with ADM and healing abutment). · Expected outcomes- includes improved peri-implant health and longevity in the ADM group. This study addresses a critical gap in peri-implant tissue management and has the potential to redefine soft tissue augmentation protocols, improving clinical outcomes while minimizing patient morbidity. |