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

Al-Azhar University

Status and phase: Not yet enrolling; Phase 3

Conditions: Periodontal Bone Defects

Treatments: Biological: Putty bone - Tricalcium phosphate with Collagen gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06553222

AUAREC20240007-5

Details and patient eligibility

About

• 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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Interventional

Experimental group

Description:

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

Treatment:

Biological: Putty bone - Tricalcium phosphate with Collagen gel

Control group

Placebo Comparator group

Description:

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

Treatment:

Biological: Putty bone - Tricalcium phosphate with Collagen gel