Localized Aggressive PeriodontitisPhase 2NCT04722380
Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects
A Phase 2 study testing periodontal regenerative surgery in people with Localized Aggressive Periodontitis, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Localized Aggressive Periodontitis
- What is being tested?
- periodontal regenerative surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Localized Aggressive Periodontitis
- Being tested
- periodontal regenerative surgery
- Keywords
- Nigella Sativa oil extract, Localized Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal regenerative surgeryProcedure or surgery
Also called periodontal 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
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | 10 infrabony defects treated surgically with Nigella Sativa oil extract Mixed with xenograft Receives: Procedure: periodontal regenerative surgery |
| control group | Placebo comparator | 10 infrabony defects treated surgically with xenograft alone Receives: Procedure: periodontal regenerative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing pocket depth
probing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
Measured: 6 months
clinical attachment level
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
Measured: 6 months
bleeding on probing
bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Oct 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Aggressive PeriodontitisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ahmed Yousef, Tanta University
- Investigators
- doaa bayoumi, PHD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722380
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2021
- First submitted
- 13 Jan 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects: a Combined Clinical and Histological Study
- ClinicalTrials.gov ID
- NCT04722380
- Acronym / sponsor ID
- 1
- Conditions
- Localized Aggressive Periodontitis
- Keywords
- Nigella Sativa oil extract, Localized Aggressive Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: periodontal regenerative surgery10 infrabony defects treated surgically with Nigella Sativa oil extract Mixed with xenograft |
| control group | Placebo comparator | Procedure: periodontal regenerative surgery10 infrabony defects treated surgically with xenograft alone |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- systemically healthy patients were selected
Key exclusion criteria (5 listed)
- • Smokers and pregnant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal regenerative surgeryAlso: periodontal surgeryProcedure/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 | Procedure or surgery | control group, test group |
Primary outcome
probing pocket depth
Time frame: 6 months
probing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
clinical attachment level
Time frame: 6 months
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
bleeding on probing
Time frame: 6 months
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
Time frame: 6 months
bone fill will be recorded at baseline, and 6 months at the site to be treated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
doaa bayoumi, PHD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing periodontal regenerative surgery in people with Localized Aggressive Periodontitis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
probing pocket depth (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.