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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Localized Aggressive Periodontitis
• Intervention / Treatment: Procedure: periodontal regenerative surgery

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Gharbiya
    • Tanta, Gharbiya, Egypt, 31511
      • Doaa Ahmed yousef bayoumi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: test group; 10 infrabony defects treated surgically with Nigella Sativa oil extract Mixed with xenograft	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; Other Names: periodontal surgery
PLACEBO_COMPARATOR: control group; 10 infrabony defects treated surgically with xenograft alone	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; Other Names: periodontal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding on probing	bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
clinical attachment level	clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
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
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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: doaa bayoumi, PHD, Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (ACTUAL): January 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Nigella Sativa oil extract; Localized Aggressive Periodontitis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Aggression; Periodontitis; Aggressive Periodontitis
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No