Non-Incised Papilla Flap in Deep Supraossous Defects

May 29, 2024 updated by: mahetab mohamed abdel el wahab, Ain Shams University

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

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt, 11566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIPSA in deep supra-alveolar defects without connective tissue graft
Procedure: Non-incised papila surgical approach only
Reconstructive periodontal surgery
Active Comparator: NIPSA in deep supra-alveolar defects with connective tissue graft
Procedure: Non-incised papila surgical approach with connective tissue grafting
Reconstructive periodontal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interproximal clinical attachment level gain
Time Frame: 6 MONTHS
measured from CEJ to base of pocket depth by using periodontal prob
6 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
residual pocket depth
Time Frame: 6 MONTHS
distance from gingival margin to pocket depth by using periodontal prob
6 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Non-Incised Papilla Flap

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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