New surgical technique for treating deep gum defects

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

This study is testing a new surgical method for treating deep gum problems in patients with severe gum disease who haven't improved with other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Ain Shams University (other)
• Locations: 1 site (Cairo, Cairo Governorate)
• Trial ID: NCT05864989 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the non-incised papilla surgical approach (NIPSA) in treating periodontal lesions with deep supra-alveolar defects. The NIPSA technique allows access to the periodontal defect from an apical direction, aiming to improve clinical outcomes compared to traditional marginal access methods. The study focuses on patients with periodontitis stage III and IV who have not responded to previous non-surgical treatments. The interventions include NIPSA alone or in combination with connective tissue grafting.

Who should consider this trial

Good fit: Ideal candidates are non-smokers with stage III or IV periodontitis who have not improved with prior non-surgical treatments.

Not a fit: Patients with systemic diseases contraindicating surgery or those who smoke may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with severe periodontal disease.

How similar studies have performed: While there is limited evidence on treating supra-alveolar defects, the novel approach may offer new insights into periodontal treatment.

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.

Where this trial is running

Cairo, Cairo Governorate

• Ain Shams University- Russian University in Egypt — Cairo, Cairo Governorate, Egypt (RECRUITING)

Study contacts

• Study coordinator: Mahetab mohamed A Wahab, PhD

Conditions: Periodontitis