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

NCT04722380 | Unknown Phase 2 DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Aggressive Periodontitis

Keywords

Nigella Sativa oil extract; Localized Aggressive Periodontitis

Outcome Measures

Primary Outcomes (4)

• 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

• clinical attachment level

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

  6 months

• bleeding on probing

  bleeding on probing 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

Study Arms (2)

test group

EXPERIMENTAL

10 infrabony defects treated surgically with Nigella Sativa oil extract Mixed with xenograft

Procedure: periodontal regenerative surgery

control group

PLACEBO COMPARATOR

10 infrabony defects treated surgically with xenograft alone

Procedure: periodontal regenerative surgery

Interventions

periodontal regenerative surgery PROCEDURE

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

Also known as: periodontal surgery

control group; test group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Doaa Ahmed yousef bayoumi

Tanta, Gharbia Governorate, 31511, Egypt

Location

Study Officials

• doaa bayoumi, PHD

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 25, 2021
• Study Start: October 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)