Clincosm LogoSign in Get a demo

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

Sponsor
Tanta University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04722380
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: periodontal regenerative surgery
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
10 patients, twenty sites 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.10 patients, twenty sites 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.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects: a Combined Clinical and Histological Study
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. clinical attachment level [6 months]

      clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated

    3. bleeding on probing [6 months]

      bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Doaa Ahmed yousef bayoumi Tanta Gharbiya Egypt 31511

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: doaa bayoumi, PHD, Tanta University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Doaa Ahmed Yousef, lecturer, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04722380
    Other Study ID Numbers:
    • 1
    First Posted:
    Jan 25, 2021
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Doaa Ahmed Yousef, lecturer, Tanta University
    Nigella Sativa oil extract
    Localized Aggressive Periodontitis
    Additional relevant MeSH terms:
    Periodontitis
    Aggressive Periodontitis
    Aggression

    Study Results

    No Results Posted as of Aug 3, 2021