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

NCT ID: NCT06553222

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2025-12-04

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.

Conditions

Periodontal Bone Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional

Participants receives Injectable bone putty - Minimally invasive debridement periodontal flap plus putty bone graft in three osseous wall defect

Group Type: EXPERIMENTAL

Putty bone - Tricalcium phosphate with Collagen gel

Intervention Type: BIOLOGICAL

Minimally invasive debridement periodontal flap and Bone graft placement to augment the lost alveolar bone

Control group

\- Participants receive No graft (No drug) Minimally invasive debridement periodontal flap

Group Type: PLACEBO_COMPARATOR

Putty bone - Tricalcium phosphate with Collagen gel

Intervention Type: BIOLOGICAL

Minimally invasive debridement periodontal flap and Bone graft placement to augment the lost alveolar bone

Interventions

Putty bone - Tricalcium phosphate with Collagen gel

Minimally invasive debridement periodontal flap and Bone graft placement to augment the lost alveolar bone

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Hagar Ahmed Saad

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AUAREC20240007-5

Identifier Type: -

Identifier Source: org_study_id