Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects

Phase 2

• Conditions: Localized Aggressive Periodontitis
• Interventions: Procedure: periodontal regenerative surgery

• Registration Number: NCT04722380
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study will be to evaluate, clinically, and radiographically the effect of Nigella Sativa oil extract Mixed with xenograft versus xenograft alone in the treatment of intra-bony defects in patients with aggressive periodontitis.

Detailed Description

in 10 patients, twenty sites in subjects with, localized aggressive periodontitis, with CAL ≥ 5 will be included in the present study. Sites will be allocated randomly to be surgically treated with, Nigella Sativa oil extract Mixed with xenograft or xenograft alone. At baseline, 3, 6 after surgery, the following clinical parameters (PD, CAL, BOP) and CBCT at baseline and 6 months x-ray will be recorded.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-25
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-31
• Last Update Posted: 2021-08-03
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• systemically healthy patients were selected

  • patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
  • Patients should demonstrate their ability to maintain good oral hygiene

Exclusion Criteria

• • Smokers and pregnant patients.

  • Medically compromised patients and systemic conditions precluding periodontal surgery.
  • Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
  • Restoration or caries in the site to be treated or non-vital tooth
  • Restoration or caries in the site to be treated or non-vital tooth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	periodontal regenerative surgery	10 infrabony defects treated surgically with Nigella Sativa oil extract Mixed with xenograft
control group	periodontal regenerative surgery	10 infrabony defects treated surgically with xenograft alone

Primary Outcome Measures

Name	Time	Method
clinical attachment level	6 months	clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
probing pocket depth	6 months	probing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
bleeding on probing	6 months	bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring bone fill	6 months	bone fill will be recorded at baseline, and 6 months at the site to be treated

Trial Locations

Locations (1)

Doaa Ahmed yousef bayoumi; 🇪🇬 Tanta, Gharbiya, Egypt