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

Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Periodontal Attachment Loss
• Intervention / Treatment: Procedure: non - Incised Papilla surgical approach NIPSA for intrabony defect; Procedure: single-flap approach SFA

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa Ali, P.h.D; Phone Number: 01003646556; Email: alaa.ali@dent.aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 23145
    • Recruiting
    • faculty of dentistry ,Assiut university
    • Contact: Alaa Ali, Ph.D.; Phone Number: 01003646556; Email: alaa.ali@dent.aun.edu.eg
    • Sub-Investigator: Aya Ali, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: non - Incised Papilla surgical approach NIPSA for intrabony defect; As described by Rodríguez and Caffesse in 2018, a single incision apical to the defect ,on the buccal aspect, only one apical horizontal or oblique incision will be made in the alveolar mucosa, as far removed as possible from the interdental papillae and marginal keratinized tis- sues. Following flap reflection, the bony defect will be examined carefully. Root planing is performed,. Flap closure will be performed by horizontal mattress sutures, placed 3 mm away from the borders, will be used as the first line of closure, promoting connective tissue contact between both edges of the incision, and single interrupted sutures will then be placed as a second line of closure. Using 5/0 polypropylene monofilament suture, Assut, Swiss
Active Comparator: single-flap approach; group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF	Procedure: single-flap approach SFA; As described by Trombelli et al 2010, A horizontal, butt-joint incision will be performed at the interdental papilla 1-2 mm coronal to the bone crest (as detected through pre-operative bone sounding). -A buccal mucoperiosteal envelope flap will be elevated by using a microsurgical periosteal elevator, leaving the residual portion of the interdental supracrestal soft tissues undetached.Flap closure will be performed by a horizontal internal mattress suture,will be performed at the base of the papilla, and a second internal mattress suture (vertical or horizontal) was performed between the most coronal portion of the flap and the most coronal portion of the palatal/lingual papilla. Using a resorbable suture

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Assiut University; Egyptian Russian University
• Investigators: Study Director: ALAA T ALI, PhD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Estimated): August 7, 2024
• Study Completion (Estimated): September 7, 2024

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: August 19, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Periodontal Attachment Loss
• Other Study ID Numbers: PER243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No