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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04722380
Enrollment
10
Registered
2021-01-25
Start date
2020-10-01
Completion date
2021-12-01
Last updated
2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localized Aggressive Periodontitis

Keywords

Nigella Sativa oil extract, Localized Aggressive Periodontitis

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.

Interventions

PROCEDUREperiodontal 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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
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

Design outcomes

Primary

MeasureTime frameDescription
probing pocket depth6 monthsprobing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
clinical attachment level6 monthsclinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
bleeding on probing6 monthsbleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring bone fill6 monthsbone fill will be recorded at baseline, and 6 months at the site to be treated

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026