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CTRI Number  CTRI/2024/10/074763 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECT OF RESORBABLE AND NON- RESORBABLE MENBRANE ON BONE GAIN OF RESORBED RIDGE -RCT 
Scientific Title of Study   A RANDOMIZED CONTROL TRIAL TO DETERMINE THE BONE GAIN AFTER THE ALVEOLAR BONE REGENERATION USING RESORBABLE AND NON- RESORBABLE MEMBRANE AT EDENTULOUS SITE FOR IMPLANT PLACEMENT. 
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 PRONOB SANYAL 
Designation  Professor and Head 
Affiliation  Krishna Vishwa Vidhyapeet Deemed to be University. Karad 
Address  Department of Prosthodontics, School of Dental Sciences, Krishna Vishwa Vidhyapeet Deemed to be University. Karad

Satara
MAHARASHTRA
415110
India 
Phone  9822046109  
Fax    
Email  sanyalpronob@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shubha Joshi 
Designation  Associate Professor 
Affiliation  Krishna Vishwa Vidhyapeet Deemed to be University. Karad 
Address  Department of Prosthodontics, School of Dental Sciences, Krishna Vishwa Vidhyapeet Deemed to be University. Karad

Satara
MAHARASHTRA
415110
India 
Phone  9900154295  
Fax    
Email  drkamnoorshubha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubha Joshi 
Designation  Associate Professor 
Affiliation  Krishna Vishwa Vidhyapeet Deemed to be University. Karad 
Address  Department of Prosthodontics, School of Dental Sciences, Krishna Vishwa Vidhyapeet Deemed to be University. Karad


MAHARASHTRA
415110
India 
Phone  9900154295  
Fax    
Email  drkamnoorshubha@gmail.com  
 
Source of Monetary or Material Support  
Krishna Vishwa Vidhyapeet Deemed to be University. Karad, Maharastra, India 
 
Primary Sponsor  
Name  Krishna Vishwa Vidhyapeet Deemed to be University. Karad 
Address  Krishna Vishwa Vidhyapeet Deemed to be University. Malkapur, Karad. 4152110 
Type of Sponsor  Other [Deemed University] 
 
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 Shubha Joshi  School of Dental Sciences  Krishna Vishwa Vidhyapeet Deemed to be University. Karad
Satara
MAHARASHTRA 
9900154295

drkamnoorshubha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Krishna Vishwa Vidhyapeet Deemed to be University.Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K063||Horizontal alveolar bone loss,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  autogenous and anorganic bovine bone mineral with Non-Resorbable membrane  autogenous and anorganic bovine bone mineral mixed in 1:1 ratio and Non-Resorbable membrane used to cover the horizontal defect that is observed at baseline, 6 months/ at implant placement and 6 months after implant placement 
Comparator Agent  autogenous and anorganic bovine bone mineral Resorbable membrane  autogenous and anorganic bovine bone mineral mixed in 1:1 ratio and Resorbable membrane used to cover the horizontal defect that is observed at baseline, 6 months/ at implant placement and 6 months after implant placement 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Partial edentulism of maxilla or mandible with vertical and horizontal bone resorption of the alveolar ridge requiring three-dimensional bone regeneration for prosthetically guided implant placement.

 
 
ExclusionCriteria 
Details  person smoking more than 10 cigarettes per day, pregmant women, person on daily medication,  
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate the horizontal bone gain using native collagen membrane with 1:1 mixture of autogenous particulate and anorganic bovine bone mineral (ABBM) vs using titanium mesh with the same mixture of bone particulate for GBR of horizontally deficient maxillary ridges with residual alveolar width ranging from 2 to 4 mm.   Baseline, 6 months after surgery and 6 months after implant placement. 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate the histomophometric analysis of bone area percent using native collagen membrane with 1:1 mixture of autogenous particulate and anorganic bovine bone mineral (ABBM) vs using titanium mesh with the same mixture of bone particulate for GBR of horizontally deficient maxillary ridges with residual alveolar width ranging from 2 to 4 mm.   Baseline, 6 months after surgery and 6 months after implant placement 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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   N/A 
Date of First Enrollment (India)   24/10/2024 
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 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  

Dental implants have become one of the most sought procedures to restore missing teeth. Among the challenges that may hinder successful implant placement is the inadequate ridge volume. Many techniques have been discussed in literature to manage horizontal ridge deficiency including onlay block grafting, ridge splitting, and guided bone regeneration. Guided bone regeneration (GBR) has been successfully established in restoring horizontal bone deficiency in maxilla, which rely on preventing the soft tissue cells incorporation into the bone graft or the space created by the defect and allow only the osteogenic cells to be present, thus resulting in bone formation into this space. This is achieved by different barriers which can be resorbable or nonresorbable. Among resorbable barriers are collagen membranes, crosslinked or non-crosslinked, polyglygolic acid membranes and other types as reported in literature. Nonresorbable membranes include d-PTFE, e-PTFE, titanium foils, and titanium meshes. Different mixtures of particulate bone graft have been proposed in literature. These include an equal mixture of autogenous and anorganic bovine bone mineral which showed successful horizontal augmentation for guided bone regeneration with a non-crosslinked collagen membrane. The factors that enable successful guided bone regeneration with native collagen membrane include its biocompatibility, the rapid vascularization for the particulate graft necessary for its maturation and its elasticity allows for a higher volume of particulate graft. However, it cannot maintain the shape of the augmented defect without collapsing. On the other hand, titanium mesh can provide volumetric stability without being affected by the overlying muscle action despite the reported risk of wound dehiscence associated with titanium meshes.

Hence, the aim of the present study was to evaluate the horizontal bone gain as a primary outcome and histomophometric analysis of bone area percent as a secondary outcome using native collagen membrane with 1:1 mixture of autogenous particulate and anorganic bovine bone mineral (ABBM) vs using titanium mesh with the same mixture of bone particulate for GBR of horizontally deficient maxillary ridges with residual alveolar width ranging from 2 to 4 mm.

 
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