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 & Hospital

Status: Not yet enrolling

Conditions: Intrabony Periodontal Defect

Treatments: Procedure: Enamel matrix derivative

Study type: Interventional

Funder types: Other

Identifiers

NCT06530199

02_D012_147502

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

control group

Active Comparator group

Description:

Simplified papilla preservation flap with enamel matrix derivative will be performed

Treatment:

Procedure: Enamel matrix derivative

Test group

Experimental group

Description:

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

Treatment:

Procedure: Enamel matrix derivative