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

NCT06647186 | Completed

• 1 other identifier: A10020822
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Periodontitis; Periodontal regeneration

Outcome Measures

Primary Outcomes (1)

• Gingival Recession

  Three and six months

Secondary Outcomes (7)

• Location of the tip of the papilla

  Three and six months

• Width of keratenized tissue

  Three and six months

• Probing depth reduction

  Three and six months

• Clinical attachment gain

  Three and six months

• Plaque index

  Three and six months

Study Arms (2)

Study group

ACTIVE COMPARATOR

Ten patients treated with Non-Incised Papillae Surgical Approach (NIPSA) plus Allograft bone substitute

Procedure: Non Incised Papillae Surgical Approach

Control group

ACTIVE COMPARATOR

Ten patients treated with Conventional Flap plus Allograft bone substitute

Procedure: Conventional flap design

Interventions

Non Incised Papillae Surgical Approach PROCEDURE

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.

Also known as: NIPSA

Study group

Conventional flap design PROCEDURE

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.

Also known as: Single flap approach

Control group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with stage III/IV periodontitis.
• Age Group between 30 to 50 years old.
• Active residual pockets (positive bleeding on probing) associated with intrabony defects.
• Periodontal lesions with probing depth (PD) ≥ 5 mm and extension of the intrabony defect ≥ 3 mm.
• Vertical intrabony periodontal defects, always involving the buccal aspect.

You may not qualify if:

• Systemic disease contraindicating periodontal surgery.
• Smokers.
• Diabetic patients.
• Pregnant patients.
• Third molars or teeth with incorrect endodontic or restorative treatment.

Sponsors & Collaborators

• Bassant Hamdy Mowafey: lead

Study Sites (1)

Faculty of Dentistry Mansoura Univesity

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontitis

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Professor Una Mohamed ElShinnawi

  Faculty of Dentistry Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients were randomly selected into either study group (NIPSA) or control group (Conventional falp) using the coin toss method. Hence the study groups were classified into two groups as follows, group I (study group): ten patients treated with NIPSA plus FDBA and group II (Control group): ten patients treated with conventional flap design plus FDBA.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor of Oral Diagnosis and Radiology

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: June 12, 2023
• Primary Completion: December 20, 2023
• Study Completion: September 1, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

EG (1)