Simplified Papilla Preservation Flap(SPPF) and Enamel Matrix Derivative(EMD) With or Without Connective Tissue(CTG) Wall for the Treatment of Non Contained Infrabony Defects. A Randomized Controlled Clinical Trail

N/ANot Yet RecruitingNCT06530199

Krishnadevaraya College of Dental Sciences & Hospital30 enrolled

Overview

Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique .The objectives is to assess the probing pocket depth reduction, clinical attachment level gain,gingival recession depth and radiographic bone gain. The TEST group will be treated withSIMPLIFIED PAPILLA PRESERVATION flap with connective tissue graft and enamel matrix derivative and the CONTROL group will be treated with SIMPLIFIED APILLA PRESERVATION flap and enamel matrix derivative. The total number of participants included will be 30 (Control-15; Study-15) with a 6 month follow up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intrabony Periodontal Defect

Interventions

Enamel matrix derivativePROCEDURE

connective tissue graft and Enamel matrix derivative in the defect area

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients willing to participate in the study. * Participants aged ≥18 years to 55 years. * Presented with non contained infra bony defects. * Presence of at least 1 non contained infra bony defect(IBD) with a pocket probing depth ≥6mm after reevaluation of the hygienic phase and a depth of IBD ≥3mm as detected on radiographs, with radiographic angulation of ≥37⸰ , and exhibiting a 1 or 2 wall infra bony defect15(assessed by a bone sounding and confirmed intrasurgically) * Patient's full mouth plaque score and bleeding score \<20% at the time of surgical procedure. * No history of periodontal surgery at the experimental site. Exclusion Criteria: * Grade III mobility, endodontically treated teeth. * Pregnant and lactating females. * History of tobacco smoking . * Patients with systemic disease. * Known allergy or hypersensitivity to EMD. * Presence of pulpal and peri apical involvement

Outcomes

Primary Outcomes

clinical attachment gain

change in attachment level for patient with isolated 2 or 3 wall defect treated with enamel matrix derivative and connective tissue wall graft in 1,3 and 6 months follow up

Time frame: 6 months

Secondary Outcomes

pocket probing depth

change in pocket probing depth from baseline to 1,3 and 6 months

Time frame: 6 months

radiographic bone gain

change in radiographic bone level from baseline to 1,3,6 months

Time frame: 6 months

recession reduction

change in recession from baseline to 1,3 and 6 months

Time frame: 6 months

plaque index

change in plaque index from baseline to 1,3 and 6 months

Time frame: 6 months

gingival index

change in calculus index from baseline to 1,3 and 6 months

Time frame: 6 months

Central Contacts

Prabhuji MLV, MDS

CONTACT

9448057407 prabhujimlv@gmail.com

Head of the department and professor

CONTACT

Data from ClinicalTrials.gov

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