Enamel Matrix Derivative and Demineralized Freeze-Dried Bone Allograft in treatment of Class II furcation defect

Phase 2

Not yet recruiting

Conditions: Chronic periodontitis,

Registration Number: CTRI/2023/08/056791

Lead Sponsor: Sardar Patel Post Graduate Institute of Dental and Medical Sciences

Brief Summary: Periodontal disease is considered the 6th most prevalent disease in the world.Periodontitis is an inflammatory disease of the periodontium which elicits an immuneresponse resulting in the loss of supporting structures of the teeth. The term â€œfurcationinvolvementâ€ is used to describe the resorption of the alveolar bone into the bi- andtrifurcation area of multirooted tooth due to progression of periodontal disease, as describedby American Academy of Periodontology. Enamel Matrix Derivative (EMD) is derived fromdeveloping porcine teeth that initiates formation of acellular root cementum and stimulatesdevelopment of periodontal ligament and alveolar bone. DFDBAâ€™s osteoinductive propertystimulates bone formation and is related to amount of bone morphogenetic protein thatremains after the demineralization process is completed. GTR helps in guiding theproliferation of periodontal tissues that aids in healing after periodontal surgery. This study isdone to evaluate the efficacy of EMD and DFDBA graft on bone regeneration in furcationClass II defects.In this study 33 patients diagnosed with periodontitis showing pocket depth >5mmand radiographic evidence of Class II furcation defects will be selected from department ofPeriodontology, SPPGIDMS, Lucknow. The patients will be randomly divided into threegroups. Group A (OFD +EMD+GTR), Group B (OFD+DFDBA+GTR) and Group C (OFD+GTR). Clinical periodontal parameters probing depth [vertical probing depth (VPD)horizontal probing depth (HPD)], bleeding on probing (BOP), gingival margin position(GMP), relative vertical and horizontal clinical attachment level (RVCAL and RHCAL), andradiographic parameters [vertical and horizontal bone level (VBL and HBL) and hard tissuefill (HTF)] will be taken to check bone height at baseline, 3 months and 6 months aftertreatment.This study will help us know the efficacy of EMD , DFDBA and OFD alone withGTR in regenerative treatment for furcation defects. We anticipate that this will enable newor improved treatment of periodontal furcation defects.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 33

Inclusion Criteria

Patients willing for voluntary participation & have signed informed consent for the described procedure.
Systemically healthy patients (ASA I & II) with Periodontitis Class II buccal furcation defects of horizontal component more than 3mm on clinical & radiographic evaluation The sites should exhibit clinical evidence of PPD of more than 3mm and CAL of more than 2mm Patients with established willingness and ability to perform adequate oral hygiene.

Exclusion Criteria

1.Subjects who have received periodontal flap/regenerative therapy within the past 1 year Patients who have received antibiotic therapy within the past six months Pregnant and lactating patients Smokers and tobacco chewers Patients who demonstrate poor oral hygiene maintenance after Phase I therapy Tooth with gingival recession exposing furcation, endodontic-pulpal involvement, or mobility > Grade II Systemic illness known to affect the outcomes of periodontal therapy; such as uncontrolled diabetes mellitus, cardiac diseases, immune-compromised (e.g., HIV individuals, under radiotherapy), patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing Patients with any known allergy to drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The possible outcome of this study will be to see the improvement in Clinical Attachment Level and Bone forming capacity using Enamel Matrix Derivative in furcation defects	Baseline \| 3 Months \| 6 Months

Secondary Outcome Measures

Name	Time	Method
To assess gingival inflammation	Baseline

Trial Locations

Locations (1): Sardar Patel Post Graduate Institute of Dental and Medical Sciences
🇮🇳
Lucknow, UTTAR PRADESH, India
Sardar Patel Post Graduate Institute of Dental and Medical Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Ria Sahay
Principal investigator
8580006039
riasahay2015@gmail.com