Non-Incised Papilla Flap in Deep Supraossous Defects

NCT05864989 | Recruiting

• 1 other identifier: 1240
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 .

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• interproximal clinical attachment level gain

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

  6 MONTHS

Secondary Outcomes (1)

• residual pocket depth

  6 MONTHS

Study Arms (2)

NIPSA in deep supra-alveolar defects without connective tissue graft

EXPERIMENTAL

Procedure: Non-incised papila surgical approach only

NIPSA in deep supra-alveolar defects with connective tissue graft

ACTIVE COMPARATOR

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

Interventions

Non-incised papila surgical approach only PROCEDURE

Reconstructive periodontal surgery

NIPSA in deep supra-alveolar defects without connective tissue graft

Non-incised papila surgical approach with connective tissue grafting PROCEDURE

Reconstructive periodontal surgery

NIPSA in deep supra-alveolar defects with connective tissue graft

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• systemic disease contraindicating periodontal surgery,
• smokers, and
• third molars or teeth with incorrect
• endodontic or restorative treatment.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University- Russian University in Egypt

Cairo, Cairo Governorate, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Mahetab mohamed A Wahab, PhD

CONTACT

01115554490; mahetabmohamed@dent.asu.edu.eg

Mahetab mohamed A Wahab

CONTACT

01005251611; mahetabmohamed@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 18, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)