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NCT07737834

Overview

NCT ID: NCT07737834
Lead Sponsor: Medical University of WarsawOTHER
Official Title: Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
Brief Summary: This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.
Conditions: Intrabony Periodontal Defect
Interventions: Entire Papilla Preservation Technique (EPPT)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Sep 30, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age ≥ 18 years,

Good compliance and good oral hygiene

Systemically healthy

Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph

The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.

Exclusion Criteria:

Full-mouth plaque score ≥ 20% (O'Leary et al 1972)

Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)

Smoking

Systemic diseases that would adversely influence wound healing

Medications interfering with post-operative wound healing

Pregnant and lactating females

Previous periodontal surgery in the examined area

III-degree mobility

Furcation involvement

Pulpal pathology or inadequate endodontic treatment

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Małgorzata Wyszyńska-PomianContact
malgorzata.wyszynska@wum.edu.pl

Similar Studies

Participant Group/Arms

Entire Papilla Preservation Technique (EPPT) + EMDActive Comparator

Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material as needed. Flaps are repositioned and sutured for primary closure.

Procedure: Entire Papilla Preservation Technique (EPPT)

Other: EDTA root conditioning

Drug: Enamel Matrix Derivative (EMD)- Emdogain

Other: Bone substitute - Bio Oss Collagen

Entire Papilla Preservation Technique (EPPT) + EMD+ SCTGExperimental

Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD) and subepithelial connective tissue graft (SCTG). After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material. A subepithelial connective tissue graft is harvested and placed at the defect site prior to flap closure.

Procedure: Entire Papilla Preservation Technique (EPPT)