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Non-Incised Papilla Flap in Deep Supraossous Defects

A

Ain Shams University

Status

Enrolling

Conditions

Periodontitis

Treatments

Procedure: Non-incised papila surgical approach only
Procedure: Non-incised papila surgical approach with connective tissue grafting

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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 .

Enrollment

16 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

16 participants in 2 patient groups

NIPSA in deep supra-alveolar defects without connective tissue graft
Experimental group
Treatment:
Procedure: Non-incised papila surgical approach only
NIPSA in deep supra-alveolar defects with connective tissue graft
Active Comparator group
Treatment:
Procedure: Non-incised papila surgical approach with connective tissue grafting

Trial contacts and locations

1

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Central trial contact

Mahetab mohamed A Wahab; Mahetab mohamed A Wahab, PhD

Data sourced from clinicaltrials.gov

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