Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect

Not Applicable

Recruiting

• Conditions: Periodontal Attachment Loss
• Interventions: Procedure: non - Incised Papilla surgical approach NIPSA for intrabony defect; Procedure: single-flap approach SFA

• Registration Number: NCT06003322
• Lead Sponsor: Ain Shams University

Brief Summary

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Detailed Description

The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.

Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)

Study Timeline

• Study First Submitted: 2023-06-24
• Status Verified: 2023-08
• Study Start: 2023-08-07
• Study First Submitted QC: 2023-08-19
• Last Update Submitted: 2023-08-19
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2024-08-07
• Study Completion: 2024-09-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• • Age > 18 years
• Diagnosis with stage III-IV periodontitis.
• Presence of one or more intrabony defects with probing pocket depth (PPD) > 5 mm and radiographic defect depth > 4 mm.
• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 30% (measured at four sites per tooth).
• No relevant systemic condition or disease.

Exclusion Criteria

Third molars and teeth with type III mobility or with an incorrect endodontic or restorative treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non - Incised Papilla surgical approach NIPSA for intrabony defect	non - Incised Papilla surgical approach NIPSA for intrabony defect	Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF
single-flap approach	single-flap approach SFA	group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF

Primary Outcome Measures

Name	Time	Method
interproximal clinical attachment level change	at baseline ,6 and 12 months	CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe

Secondary Outcome Measures

Name	Time	Method
residual probing pocket depth (PPD), pocket depth (PD) change,	at at baseline ,6 and 12 months	-Inter- proximal PD, measured in the interproximal space from the gingival margin to the BP measured by a millimeter periodontal probe

Trial Locations

Locations (1)

faculty of dentistry ,Assiut university; 🇪🇬 Assiut, Egypt