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

NCT ID: NCT06530199

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-07-31

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.

Conditions

Intrabony Periodontal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

Simplified papilla preservation flap with enamel matrix derivative will be performed

Group Type: ACTIVE_COMPARATOR

Enamel matrix derivative

Intervention Type: PROCEDURE

connective tissue graft and Enamel matrix derivative in the defect area

Test group

Simplified papilla preservation flap with connective tissue graft and enamel matrix derivative will be performed

Group Type: EXPERIMENTAL

Enamel matrix derivative

Intervention Type: PROCEDURE

connective tissue graft and Enamel matrix derivative in the defect area

Interventions

Enamel matrix derivative

connective tissue graft and Enamel matrix derivative in the defect area

Intervention Type: PROCEDURE

Other Intervention Names

Connective tissue graft technique

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Prabhuji MLV, MDS

Role: CONTACT

Phone: 9448057407

Email: prabhujimlv@gmail.com

Head of the department and professor

Role: CONTACT

Other Identifiers

02_D012_147502

Identifier Type: -

Identifier Source: org_study_id