FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
AIIMS 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
Close