| 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
|
|
|
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
|
|
|
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. |