Back to resultsNigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects
Primary Purpose
Localized Aggressive Periodontitis
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
periodontal regenerative surgery
Sponsored by
About this trial
This is an interventional treatment trial for Localized Aggressive Periodontitis focused on measuring Nigella Sativa oil extract, Localized Aggressive Periodontitis
Eligibility Criteria
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
Sites / Locations
- Doaa Ahmed yousef bayoumi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
test group
control group
Arm Description
10 infrabony defects treated surgically with Nigella Sativa oil extract Mixed with xenograft
10 infrabony defects treated surgically with xenograft alone
Outcomes
Primary Outcome Measures
probing pocket depth
probing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
clinical attachment level
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
bleeding on probing
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
bone fill will be recorded at baseline, and 6 months at the site to be treated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04722380
Brief Title
Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects
Official Title
Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects: a Combined Clinical and Histological Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Aggressive Periodontitis
Keywords
Nigella Sativa oil extract, Localized Aggressive Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Arm Description
10 infrabony defects treated surgically with Nigella Sativa oil extract Mixed with xenograft
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
10 infrabony defects treated surgically with xenograft alone
Intervention Type
Procedure
Intervention Name(s)
periodontal regenerative surgery
Other Intervention Name(s)
periodontal surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
probing pocket depth
Description
probing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
Time Frame
6 months
Title
clinical attachment level
Description
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
Time Frame
6 months
Title
bleeding on probing
Description
bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
Time Frame
6 months
Title
cone beam x ray measuring bone fill
Description
bone fill will be recorded at baseline, and 6 months at the site to be treated
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
doaa bayoumi, PHD
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doaa Ahmed yousef bayoumi
City
Tanta
State/Province
Gharbiya
ZIP/Postal Code
31511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects
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