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Clinical Trials/NCT06530199
NCT06530199
Not yet recruiting
Not Applicable

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

Krishnadevaraya College of Dental Sciences & Hospital0 sites30 target enrollmentJuly 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intrabony Periodontal Defect
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Enrollment
30
Primary Endpoint
clinical attachment gain
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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 .

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2024
End Date
July 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Time Frame: 6 months

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

Secondary Outcomes

  • pocket probing depth(6 months)
  • recession reduction(6 months)
  • plaque index(6 months)
  • gingival index(6 months)
  • radiographic bone gain(6 months)

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