| CTRI Number |
CTRI/2024/11/077176 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Use of a gum graft from palate or a dressing processed from animal skin for improving gum tissue height around dental implants |
|
Scientific Title of Study
|
Comparison of clinical outcomes, histomorphometric and gene expression analysis of connective tissue graft with two types of xenogeneic matrices for peri-implant vertical soft tissue augmentation |
| 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 Vikender Singh |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 510
5th Floor
Division of Periodontics
Centre for Dental Education and Research
All India Institute of Medical Sciences
Ansari Nagar, New Delhi - 110029
South West DELHI 110029 India |
| Phone |
8800798248 |
| Fax |
|
| Email |
vikenderyadav@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vikender Singh |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 510
5th Floor
Division of Periodontics
Centre for Dental Education and Research
All India Institute of Medical Sciences
Ansari Nagar, New Delhi - 110029
South West DELHI 110029 India |
| Phone |
8800798248 |
| Fax |
|
| Email |
vikenderyadav@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vikender Singh |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 510
5th Floor
Division of Periodontics
Centre for Dental Education and Research
All India Institute of Medical Sciences
Ansari Nagar, New Delhi - 110029
South West DELHI 110029 India |
| Phone |
8800798248 |
| Fax |
|
| Email |
vikenderyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
All India Institute of Medical Sciences
Ansari Nagar
New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vikender Singh |
AIIMS, New Delhi |
Division of Periodontics
Centre for Dental Education and Research
All India Institute of Medical Sciences
Ansari Nagar, New Delhi - 110029
South West DELHI |
8800798248
vikenderyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Room No. 102, 1st floor, old O.T. Block, Ansari Nagar, New Delhi-110029 |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Commercially available acellular dermal matrix (NovoMatrixTM) |
It is also porcine in origin. It will be sutured at the surgical site and not be removed again being resorbable in nature. Duration of the study will be 4 months. |
| Intervention |
Commercially available bioresorbable volume stable collagen matrix (Fibrogide®) |
It is made of 60-90% (w/w) porcine collagen type I and III and 4-40% (w/w) elastin. It will be sutured at the surgical site and not be removed again being resorbable in nature. Duration of the study will be 4 months. |
| Comparator Agent |
Connective Tissue Graft |
Connective tissue graft will be harvested from patients palate and sutured at the surgical site for peri-implant vertical soft tissue augmentation. It will be covered with an overlying flap. The graft will be placed once only at the time of surgery and will not be removed again being autogenous in nature. Duration of the study will be 4 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(j) Systemically healthy individuals over 18 years of age
(k) Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy.
(l) Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of less than 15 percent
(m) Presence of single missing posterior tooth indicated for implant-supported prosthesis
(n) Thin mucosal tissues , less than or equal 2 mm in vertical dimension i.e. covering the edentulous alveolar ridge
(o) Minimum of 6 mm width and 8 mm height of available bone.
(p) Presence of minimum 4 mm of keratinized tissue buccolingually
(q) No need of bone augmentation procedure before and during implant placement
(r) Provide consent for the use of soft tissue matrix of porcine origin
|
|
| ExclusionCriteria |
| Details |
(a) Insufficient inter-arch space for implant-supported crown
(b) Inability or anticipated failure to maintain adequate oral hygiene
(c) Pregnancy or lactating moth¬ers
(d) Patients with other systemic conditions (uncontrolled diabetes, unstable bleeding disorders, active infectious diseases; hepatitis, tuberculosis, HIV etc.) that could affect the healing ability of wound.
(e) Mental disabilities that may hinder participation.
(f) History of active immunosuppressive therapy, cancer therapy and/or radiation to the oral cavity.
(g) Patients taking medications that affect the healing of soft tissues (e.g. NSAIDs, steroids, etc.).
(h) Smokers or tobacco usage in any form
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Vertical soft tissue thickness gain
2. Histological assessment of grafted tissue
3. Gene expression profile of grafted tissue |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of Surgery
Post-operative Pain
|
Immediate and 2 weeks respectively |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
09/12/2024 |
| 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="2" 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
|
Peri-implant soft tissues are key to maintaining peri-implant health. An adequate soft tissue seal prevents microbial ingress, provides aesthetic results and harmonious integration of the prosthesis with the remaining dentition. The connective tissue graft (CTG) harvested from the palate is the gold standard for soft tissue augmentation. However, it is associated with a need for a second surgical site, increased patient morbidity, longer surgical duration and a possibility of postsurgical complications. To address these challenges, several new biomaterials have been developed. These include newly developed porcine acellular dermal matrix (PADM) and volume stable collagen matrix (VCMX). However, it remains unclear whether they can achieve similar clinical outcomes as CTG in terms of vertical soft tissue thickness gain following submerged implant placement. The present study is aimed at comparing the clinical performance of PADM, VCMX and CTG for vertical soft tissue augmentation at implant sites presenting with baseline soft tissue thickness ≤ 2 mm. Further, histologic and histomorphometric assessment would be carried out to evaluate the inflammatory response, collagen content and micro-vessel density in the grafted tissue after 3 months of healing. Also, there is lack of data on the gene expression of biological importance during healing at molecular level in the grafted sites. Therefore, we will also characterize acute changes in gene expression by performing RNAseq analysis of the biopsied soft tissue to identify cellular pathways that become altered upon successful grafting in VCMX or PADM groups compared to CTG control. |