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CTRI Number  CTRI/2024/05/067607 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Tissue Changes Around Dental Implants with a collagen membrane versus Connective Tissue Grafts in patients with thin gingival conditions. 
Scientific Title of Study   Comparison of Soft and Hard Tissue Changes Around Dental Implants with Xenogenic Collagen and Connective Tissue Grafts Using Intraoral Scanner and Radiographs: Randomized Controlled 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 Sejal Satish Mali 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department no.202,Second floor, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur, 440003.

Nagpur
MAHARASHTRA
440003
India 
Phone  9518795547  
Fax    
Email  sejalmali1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vaibhav Karemore 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department no.202,Second floor, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur, 440003.

Nagpur
MAHARASHTRA
440003
India 
Phone  9011098882  
Fax    
Email  drperiodon@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaibhav Karemore 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department no.202,Second floor, Government Dental College and Hospital, Medical Square, Hanuman Nagar, Nagpur, 440003.


MAHARASHTRA
440003
India 
Phone  9011098882  
Fax    
Email  drperiodon@gmail.com  
 
Source of Monetary or Material Support  
Government dental college and hospital, Hanuman Nagar, Medical square, Nagpur-440003 
 
Primary Sponsor  
Name  Dr. Sejal Satish Mali 
Address  Department no. 202, department of periodontology, second floor, Government dental college and hospital , Medical square, Hanuman Nagar, Nagpur-440003  
Type of Sponsor  Other [Self sponsor] 
 
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 Sejal Satish Mali  Government dental college and hospital, Nagpur  Department no.202, department of periodontology, Government dental college and hospital, Medical square, Hanuman Nagar, Nagpur
Nagpur
MAHARASHTRA 
9518795547

sejalmali1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Government Dental College and hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Connective tissue graft  A connective tissue graft will be placed around dental implants at the time of stage II implant surgery. Soft tissue thickness, surface area around implants and crestal bone loss will be assessed after 90 days. 
Intervention  Xenogenic collagen scaffold  A Xenogenic collagen scaffold will be placed around dental implants at the time of stage II implant surgery. Soft tissue thickness, surface area around implants and crestal bone loss will be assessed after 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients with age of 18-60 years.
2)Patient who had undergone dental implant stage I surgery.
3)Patient with thin gingival phenotype.
4)Adequate oral hygiene.
 
 
ExclusionCriteria 
Details  1)Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
2)Patients with thick gingival phenotype around implants.
3)Patients with implant sites that presented complications.
4)Patients who are not willing for the xenogenic graft which is
of porcine origin.
5)Pregnant or lactating females.
6)Patients not willing to participate in the study.
 
 
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 
Evaluation of soft tissue thickness and surface area around implants.  Evaluation of soft tissue thickness will be done at baseline and after 90 days and surface area around implants will be evaluated after 90 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Crestal bone loss  Crestal bone loss will be evaluated at baseline & 90 days after stage II implant surgery.
 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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 2/ Phase 3 
Date of First Enrollment (India)   31/05/2024 
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="1"
Months="6"
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  

  

  Implant dentistry has become an integral part of modern dentistry and its success is no longer determined merely by osseointegration.There is a paradigm shift in dental implantology with an increased importance placed on the quality and quantity of soft tissues around dental implants to improve the surgical, esthetic and prosthetic outcomes of the implant therapy. 

Albrektsson recently coined this as a new concept called ‘mucointegration’ which means dense soft tissue contact with an abutment that can act as a barrier to protect the underlying bone and is the basis for long term tissue health and stability. Long term peri-implant soft tissue stability is affected by the peri-implant tissue phenotype. The term encompasses the three-dimensional gingival volume and thickness. Thin phenotype predisposes the tissues to attachment loss. They are at a higher risk of esthetic complications in the long term like mid-facial peri-implant mucosal recession, incomplete papilla fill and decreased soft tissue stability which may lead to implant failure. Crestal bone loss has been linked to thinner gingival phenotypes as the thick gingival phenotypes are less prone to buccal changes. Adequate amount of soft tissue is needed to curb the crestal bone loss & achieve biologic width of the peri-implant mucosa. Various methods have been proposed for obtaining adequate amounts of gingival soft tissue thickness depending on the technique and patients need. These can be performed before implant placement, at the time of implant placement or at the time of second stage implant surgery. Apically positioned flaps, laterally positioned flaps, free gingival grafts or connective tissue grafts are some of the most commonly used methods for increasing the zone of soft tissue thickness around implants. Current scientific data recommends the use of autogenous  connective tissue grafts (CTG) as the grafting material of choice for increasing the soft tissue thickness and improving the esthetics around dental implant sites. But the CTG is inevitably accompanied by increased morbidity as it requires an additional harvesting procedure. To overcome the drawbacks of the autogenous grafts many alternative materials such as xenogenic collagen scaffold have been developed. The fundamental issue is to choose the material which will assure the maximum therapeutic effect while minimizing the negative influence on the patient’s health. The collagen matrix offers mechanical stability associated with good biological behaviour, promotes tissue formmation, angiogenesis & similar outvomes compared to gold standard in terms of volume increase. Periodontal probes and endodontic files are commonly used to evaluate soft tissue changes. But these evaluate the changes only in one-dimension. At present, digital methods for evaluating peri-implant soft tissue changes have gradually become an outcome of interest in different literatures possibly because of its noninvasiveness, accuracy, and the digital information could be saved in computer permanently. A recent study summarized the available evidence regarding traditional and digital methods for the evaluation of peri-implant soft tissue changes and concluded that traditional methods can’t show the entire changes while digital methods can. The digital scanned files obtained by an intraoral scanner can be converted into Standard Tessellation Language (STL) file formats. These files are transferred to a three dimensional analysis software where they are superimposed and evaluation of the change in thickness can be done.  There are limited studies involving the use of digital methods for the evaluation of peri-implant soft tissue changes. Thus the aim of the study is to compare the soft and hard tissue changes around dental implants at stage II implant surgery with xenogenic collagen scaffold and connective tissue graft using intraoral digital scanner and radiographs.



 
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