Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty

Phase 3

Not yet recruiting

• Conditions: Periodontal Bone Defects
• Interventions: Biological: Putty bone - Tricalcium phosphate with Collagen gel

• Registration Number: NCT06553222
• Lead Sponsor: Al-Azhar University

Brief Summary

• All periodontitis patients with infra bony pockets to be included in this study will diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm will be treated by minimally invasive non-surgical therapy or by injectable bone putty

Detailed Description

The present study will be designed as a randomized controlled clinical and radiographic. The study will be carried out on stage III grade (B) periodontitis patients with intra-bony defects. Those patients will be selected from the outpatient clinics of the Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.

The study has bee approved by the ethical committee, Faculty of Dental medicine, Al-Azhar University, Assiut branch.

2. All patients will be fully informed about the study's nature and the possible risks of the study procedures; they sign the consent form before the work.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Study Start: 2024-11-04
• Primary Completion: 2025-10-04
• Study Completion: 2025-12-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• • All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.

  • 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability
  • All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings.

Exclusion Criteria

• Any patients with any systemic condition that contraindicate any surgical intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Putty bone - Tricalcium phosphate with Collagen gel	- Participants receive No graft (No drug) Minimally invasive debridement periodontal flap
Interventional	Putty bone - Tricalcium phosphate with Collagen gel	Participants receives Injectable bone putty - Minimally invasive debridement periodontal flap plus putty bone graft in three osseous wall defect

Primary Outcome Measures

Name	Time	Method
Primary outcome	measured at 6 and 12 months postoperative	measurement (mm) in alveolar bone gain