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

Localized Aggressive Periodontitis Clinical Trial

Official title:

Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects: a Combined Clinical and Histological Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04722380
• Other study ID #: 1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Localized Aggressive Periodontitis
• Periodontitis

Intervention

Procedure:
• periodontal regenerative surgery
Procedure/Surgery: open flap debridement Open flap for removal of diseased periodontal tissues and necrotic cementum , using xenogenic bone graft with or without Nigella Sativa oil extract

Locations

Country	Name	City	State
Egypt	Doaa Ahmed yousef bayoumi	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probing pocket depth	probing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
Primary	clinical attachment level	clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
Primary	bleeding on probing	bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
Primary	cone beam x ray measuring bone fill	bone fill will be recorded at baseline, and 6 months at the site to be treated	6 months