Non-Incised Papilla Flap in Deep Supraossous Defects

Periodontitis Clinical Trial

Official title:

Non-Incised Papilla Flap With and Without Connective Tissue Graft for Management of Deep Supraossous Defects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864989
• Other study ID #: 1240
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: Mahetab mohamed A Wahab, PhD
• Phone: 01115554490
• Email: mahetabmohamed[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Non-incised papila surgical approach only
Reconstructive periodontal surgery
• Non-incised papila surgical approach with connective tissue grafting
Reconstructive periodontal surgery

Locations

Country	Name	City	State
Egypt	Ain Shams University- Russian University in Egypt	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interproximal clinical attachment level gain	measured from CEJ to base of pocket depth by using periodontal prob	6 MONTHS
Secondary	residual pocket depth	distance from gingival margin to pocket depth by using periodontal prob	6 MONTHS