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

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Intrabony Periodontal Defect
• Intervention / Treatment: Procedure: Enamel matrix derivative

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prabhuji MLV, MDS; Phone Number: 9448057407; Email: prabhujimlv@gmail.com
• Study Contact Backup: Name: Head of the department and professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Simplified papilla preservation flap with enamel matrix derivative will be performed	Procedure: Enamel matrix derivative; connective tissue graft and Enamel matrix derivative in the defect area; Other Names: Connective tissue graft technique
Experimental: Test group; Simplified papilla preservation flap with connective tissue graft and enamel matrix derivative will be performed	Procedure: Enamel matrix derivative; connective tissue graft and Enamel matrix derivative in the defect area; Other Names: Connective tissue graft technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pocket probing depth	change in pocket probing depth from baseline to 1,3 and 6 months	6 months
radiographic bone gain	change in radiographic bone level from baseline to 1,3,6 months	6 months
recession reduction	change in recession from baseline to 1,3 and 6 months	6 months
plaque index	change in plaque index from baseline to 1,3 and 6 months	6 months
gingival index	change in calculus index from baseline to 1,3 and 6 months	6 months

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 02_D012_147502

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No