Non-Incised Papilla Flap in Deep Supraossous Defects

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05864989

Enrollment

Registered

2023-05-18

Start date

2023-04-01

Completion date

2024-11-01

Last updated

2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

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 .

Interventions

PROCEDURENon-incised papila surgical approach only

Reconstructive periodontal surgery

PROCEDURENon-incised papila surgical approach with connective tissue grafting

Reconstructive periodontal surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Contacts

Primary ContactMahetab mohamed A Wahab, PhD

mahetabmohamed@dent.asu.edu.eg01115554490

Backup ContactMahetab mohamed A Wahab

mahetabmohamed@dent.asu.edu.eg01005251611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026