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Clinical Trials/NCT05864989
NCT05864989
Recruiting
Not Applicable

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

Ain Shams University1 site in 1 country16 target enrollmentApril 1, 2023
ConditionsPeriodontitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Ain Shams University
Enrollment
16
Locations
1
Primary Endpoint
interproximal clinical attachment level gain
Status
Recruiting
Last Updated
last year

Overview

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 .

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
November 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mahetab mohamed abdel el wahab

lecturer

Ain Shams University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

interproximal clinical attachment level gain

Time Frame: 6 MONTHS

measured from CEJ to base of pocket depth by using periodontal prob

Secondary Outcomes

  • residual pocket depth(6 MONTHS)

Study Sites (1)

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