Non-Incised Papilla Flap in Deep Supraossous Defects

Not Applicable

Recruiting

• Conditions: Periodontitis
• Interventions: Procedure: Non-incised papila surgical approach only; Procedure: Non-incised papila surgical approach with connective tissue grafting

• Registration Number: NCT05864989
• Lead Sponsor: Ain Shams University

Brief Summary

The objective of this study was to assess the effectiveness of NIPSA in periodontal lesions with deep supra-alveolar defects, measuring the clinical efficacy of this flap. The non-incised papilla surgical approach (NIPSA) is a novel technique that accesses the periodontal defect from apical direction and was established with the aim of creating clinical advances compared with marginal access techniques.

The defects with a supra-alveolar components are more frequent than intrabony defects, there is very little evidence about their treatment .

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• diagnosis of periodontal disease (periodontitis stage III and IV, grade A [12];
• non-smokers and former smokers who quit smoking at least 1 year previously
• previous treatment for periodontal disease using non-surgical periodontal treatment completion of step I and II of periodontal therapy
• compliance with periodontal maintenance and oral hygiene (FMPS at baseline ≤ 30%)
• active residual pockets (positive bleeding on probing; BoP) associated with intrabony defects that were not resolved with non-surgical treatment after 4-6 months of maintenance.
• periodontal lesions with probing depth (PD) > 6 mm and supraalveolar defect (pre-diagnosis clinically (periodontal probe)

Exclusion Criteria

• systemic disease contraindicating periodontal surgery,
• smokers, and
• third molars or teeth with incorrect
• endodontic or restorative treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIPSA in deep supra-alveolar defects without connective tissue graft	Non-incised papila surgical approach only	-
NIPSA in deep supra-alveolar defects with connective tissue graft	Non-incised papila surgical approach with connective tissue grafting	-

Primary Outcome Measures

Name	Time	Method
interproximal clinical attachment level gain	6 MONTHS	measured from CEJ to base of pocket depth by using periodontal prob

Secondary Outcome Measures

Name	Time	Method
residual pocket depth	6 MONTHS	distance from gingival margin to pocket depth by using periodontal prob

Trial Locations

Locations (1)

Ain Shams University- Russian University in Egypt; 🇪🇬 Cairo, Al Qahirah, Egypt