| 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
|
|
|
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
|
|
|
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. |