Clinical trial NCT06530199: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intrabony Periodontal Defect
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: clinical attachment gain
timeFrame: 6 months
Secondary outcomes:
measure: pocket probing depth
timeFrame: 6 months
measure: radiographic bone gain
timeFrame: 6 months
measure: recession reduction
timeFrame: 6 months
measure: plaque index
timeFrame: 6 months
measure: gingival index
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: