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

NCT06003322 | Unknown DMC

• 1 other identifier: PER243
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Periodontal Attachment Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• residual probing pocket depth (PPD), pocket depth (PD) change,

  at at baseline ,6 and 12 months

Study Arms (2)

non - Incised Papilla surgical approach NIPSA for intrabony defect

EXPERIMENTAL

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

single-flap approach

ACTIVE COMPARATOR

group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF

Procedure: single-flap approach SFA

Interventions

non - Incised Papilla surgical approach NIPSA for intrabony defect PROCEDURE

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

non - Incised Papilla surgical approach NIPSA for intrabony defect

single-flap approach SFA PROCEDURE

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

single-flap approach

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead
• Assiut University: collaborator
• Egyptian Russian University: collaborator

Study Sites (1)

faculty of dentistry ,Assiut university

Asyut, 23145, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• ALAA T ALI, PhD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Alaa Ali, P.h.D

CONTACT

01003646556; alaa.ali@dent.aun.edu.eg

Study Design

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

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: August 21, 2023
• Study Start: August 7, 2023
• Primary Completion: August 7, 2024
• Study Completion: September 7, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)