Non-Incised Papilla Flap in Deep Supraossous Defects

NCT ID: NCT05864989

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-11-01

Brief Summary

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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

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NIPSA in deep supra-alveolar defects without connective tissue graft

Group Type EXPERIMENTAL

Non-incised papila surgical approach only

Intervention Type PROCEDURE

Reconstructive periodontal surgery

NIPSA in deep supra-alveolar defects with connective tissue graft

Group Type ACTIVE_COMPARATOR

Non-incised papila surgical approach with connective tissue grafting

Intervention Type PROCEDURE

Reconstructive periodontal surgery

Interventions

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Non-incised papila surgical approach only

Reconstructive periodontal surgery

Intervention Type PROCEDURE

Non-incised papila surgical approach with connective tissue grafting

Reconstructive periodontal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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mahetab mohamed abdel el wahab

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University- Russian University in Egypt

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahetab mohamed A Wahab, PhD

Role: CONTACT

01115554490

Mahetab mohamed A Wahab

Role: CONTACT

01005251611

Facility Contacts

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Mahetab mohamed A Wahab, PhD

Role: primary

01115554490

Mahetab mohamed A Wahab

Role: backup

01005251611

Other Identifiers

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1240

Identifier Type: -

Identifier Source: org_study_id

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