MedTrace Logo

Evaluation of Non-Incised Papillae Surgical Approach (NIPSA) Versus Conventional Flap in Periodontal Reconstructive Surgery of Intrabony Defects (Clinical and Radiographic Study)

NCT06647186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-17

No results posted yet for this study

Summary

Objectives: To compare the effectiveness of Non-Incised Papillae Surgical Approach (NIPSA) versus conventional flap with mineralized Freeze-Dried Bone Allograft (FDBA) in periodontal reconstructive surgery of intrabony defects (Clinical and Radiographic study).

Patients and methods: Twenty patients with stage III/IV periodontitis with vertical intraosseous defect treated with NIPSA plus FDBA (n=10) or Conventional flap plus FDBA (n=10) were analysed. All patients met the same inclusion criteria and were treated following the same protocol, except for the surgical management of soft tissue (NIPSA versus Conventional flap). Clinical parameters were assessed at baseline, three months and sixmonths. Radiographic parameters were assessed at baseline and six months.

Conditions

  • Periodontal Bone Loss

Interventions

PROCEDURE

Non Incised Papillae Surgical Approach

Ten patients were included in this group, phase I therapy (scaling, root planing and oral hygiene measures) was performed. A single horizontal or oblique incision was made in the mucosa located on the cortical bone tissue, apical to the intrabony defect. The mesiodistal extension of the incision was sufficient to allow access to the defect. Tissue coronal to the incision was raised to full thickness from the incision line to expose the bone peaks delimiting the intrabony defect. The granulation tissue was removed from the bone walls of the defect. Dental plaque and calculus deposits were removed from the root surface with ultrasonic scaler tips and micro-minicurettes. A solution of 24% Ethylenediaminetetraacetic acid (EDTA) was applied to the root surface for 2 min, irrigation with saline solution then allograft bone material was packed into the periodontal defect. The incision was sutured with horizontal internal mattress sutures then simple interrupted sutures.

PROCEDURE

Conventional flap design

Ten patients were included in this group, phase I therapy (scaling, root planing and oral hygiene measures) was performed. Intrasulcular incision was made splitting the buccal papilla from the palatal papilla. All defects were approached by elevating a flap only on the buccal side and leaving the oral portion of the interdental supracrestal soft tissues undetached. The full-thickness elevation of the marginal portion of the flap was performed with a microsurgical periosteal elevator. After removal of granulation tissue from the bone walls of the defect, root and defect debridement was performed with manual and mechanical (ultrasonic) instruments with tips for subgingival instrumentation. A solution of 24% Ethylenediaminetetraacetic acid (EDTA) was applied to the root surface for 2 min, irrigation with saline solution then allograft bone material was packed into the periodontal defect. The incision was sutured with simple interrupted sutures.

Sponsors & Collaborators

  • Bassant Hamdy Mowafey

    lead OTHER

Principal Investigators

  • Professor Una Mohamed ElShinnawi · Faculty of Dentistry Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2023-12-20
Completion
2024-09-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647186 on ClinicalTrials.gov