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NCT Number: NCT06553222

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

• 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

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Putty bone - Tricalcium phosphate with Collagen gel

Biological

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

Primary outcomes

  1. Primary outcome

    Time frame: measured at 6 and 12 months postoperative

    measurement (mm) in alveolar bone gain

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty in Treating Intra-bony Periodontal Defects (Randomized Controlled Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.