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CTRI Number  CTRI/2025/10/096578 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two membranes in the treatment of bone loss in the teeth. 
Scientific Title of Study   Volumetric Assessment of Regenerative Efficacy of Demineralized Freeze Dried Bone Allograft with Placental membranes (Amnion membrane and Chorion membrane) in Open Flap Debridement in the Management of Mandibular Degree II Furcation Defects using Cone Beam Computed Tomography with 6 months follow up A Randomized Clinical 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  Vimarsha R Achar 
Designation  Postgraduate 
Affiliation  Manipal College Of Dental Sciences, Mangalore 
Address  Department of Periodontology,Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7022020172  
Fax    
Email  vimarsharamesh12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeeta U Nayak 
Designation  Associate proffesor 
Affiliation  Manipal College Of Dental Sciences, Mangalore 
Address  Department of Periodontology, 4th Floor, Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7022020172  
Fax    
Email  sangeeta.nayak@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Vimarsha R Achar 
Designation  Postgraduate 
Affiliation  Manipal College Of Dental Sciences, Mangalore 
Address  Department of Periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education, Manipal

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7022020172  
Fax    
Email  vimarsharamesh12@gmail.com  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education, Manipal, Karnataka – 575001  
 
Primary Sponsor  
Name  Dr Vimarsha R Achar 
Address  Department of Periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education, Manipal, Karnataka – 575001 
Type of Sponsor  Other [Self] 
 
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 Vimarsha R A char  Manipal College Of Dental Sciences, Mangalore  Department of Periodontology, 4th Floor, Manipal College of Dental Sciences, Mangalore Affiliated to Manipal Academy of Higher Education, Manipal, Karnataka – 575001
Dakshina Kannada
KARNATAKA 
7022020172

vimarsharamesh12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  amnion membrane   Comparative evaluation and volumetric assessment of regenerative efficacy of demineralized freeze-dried bone allograft with placental membranes (amnion and chorion membrane) in open flap debridement in management of degree ii mandibular furcation defects over a 6 months follow up 
Comparator Agent  chorion membrane  Comparative evaluation and volumetric assessment of regenerative efficacy of demineralized freeze-dried bone allograft with placental membranes (amnion and chorion membrane) in open flap debridement in management of degree ii mandibular furcation defects over 6 months follow up 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Systemically healthy male or female patients
Moderate to severe chronic periodontitis stage III.
Probing pocket depth and clinical attachment level more than 5mm
At least one degree II (as per Hamp et al classification) furcation defect on
mandibular posteriors Determined by clinical examination and later by radiographic
evaluation 
 
ExclusionCriteria 
Details  History of known systemic diseases
Allergies
Drug use
Having undergone surgical periodontal therapy in last 6 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Plaque index
Gingival index
Probing pocket depth
Clinical attachment level
Horizontal probing depth
 
baseline
3 months
6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
defect height
defect width
defect depth 
baseline
6 months 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 3/ Phase 4 
Date of First Enrollment (India)   10/11/2025 
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  

Periodontal disease is an inflammatory condition which result in progressive destruction of the periodontium occurs as a result of specific microorganism or groups of microorganisms as the destruction of the periodontium progresses apically, the furcation of multirooted teeth is exposed, leading to the irreversible bone loss in the interradicular area. The management of furcation involvement presents one of the greatest challenges in periodontal therapy, as these defects respond less favourably to the conventional periodontal therapy and lead to the loss of molars than any other tooth type. The treatment of furcation defects represents a great challenge because of their intricate anatomy and variable morphology, which complicates access for proper hygiene, and maintenance. Attempts to treat furcation defects have led to therapies ranging from nonsurgical periodontal therapy, such as scaling and root planing (SRP), to surgical root debridement, root resection, hemi section, regenerative therapy. The most predictable method to treat degree II furcation involvement in mandibular molars and buccal furcation’s in maxillary molars is by regenerative procedures. The ultimate aim of the regenerative procedures is to exclude the epithelium and the gingival corium from the root to delay epithelial down growth during healing and to provide an opportunity for progenitor cells of the periodontal ligament and bone to repopulate previously diseased root surfaces using regenerative materials. Studies have shown that guided tissue regeneration (GTR) can improve the response of advanced grade II furcation defects to therapy by means of pocket depth reduction, gain in clinical attachment levels and bone defect fill DFDBA is thought to be responsible for osteoconductive effect and source of osteoinductive factors because of the presence of “bone morphogenic proteins” The use of demineralized freeze-dried bone allograft (DFDBA) as a bone replacement graft capable of promoting regeneration of the attachment apparatus and has been the focus of much attention throughout the past 30 years and several studies have shown DFDBA as a graft material of greater osteogenic potential when compared to FDBA. Recently amniotic membranes of the developing embryo, that is, amnion (innermost lining) and chorion (a layer next to it), have the properties with significant potential used in dentistry. Placental membranes having their origin from extraembryonic tissue. Amnion is derived from this fetal membrane consists of inner amniotic membrane made up of single layer of amnion cells fixed to collagen rich mesenchyme attached to chorion which is the outermost of the two fetal membranes and is contact with amnion on its inner aspect. Amniotic membrane is a novel tissue engineering biomaterial that has recently been used in the field of dentistry to regenerate lost tissues and accelerate repair. The membrane has numerous growth factors, proteins, and stem cell reserves that help in faster wound healing with regeneration of the lost tissues. The CM membrane has numerous growth factors, proteins, and stem-cell reserves that induce faster wound healing and aid the regeneration of lost tissue. The immuno-privileged human chorion membrane (CM) has antimicrobial and antigenic properties that have been discussed extensively, and it has been recently used for periodontal therapy. Various methods have been adopted for pre- and postsurgical evaluation of the periodontal treatment, including clinical probing, conventional radiographs, surgical re-entry and histologic examination. However, most of these methods failed to evaluate the exact morphology of the periodontal tissues. The advent of cone beam computed tomography (CBCT) enabled clinicians to precisely identify the three-dimensional morphology of the osseous defects along with volumetric assessment of healing periodontal tissues. Effectiveness of the surgical procedure and material used have been assessed in periodontal research by various means, CBCT is one of the non-invasive methods where the volumetric assessment of the bone defect can be done and its application provides significant aid for better understanding of the furcation defects. Thus, aim of present study is to comparative evaluation and volumetric assessment of regenerative efficacy of DFDBA with the placental membranes (amnion and chorion) in open flap debridement in the management of mandibular degree II furcation clinically and radiographically at baseline, 3, 6 months and 6 months follow up.

 
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