Radiographic EvaluationNCT07765745
Effect of Thymoquinone 0.2% Gel on Bone Density, Bone Width, and Socket Preservation After Tooth Extraction
A study testing Gel foam, Thymoquinone gel + gel foam and Nano-formulated 0.2% thymoquinone gel + gel foam in people with Radiographic Evaluation and Bone Density, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to evaluate the clinical and radiographic effects of 0.2% Thymoquinone gel on bone density, bone width, and socket preservation after tooth extraction. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Radiographic Evaluation, Bone Density, Bone Width
- What is being tested?
- Gel foam, Thymoquinone gel + gel foam and Nano-formulated 0.2% thymoquinone gel + gel foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-50 years.
- Both sexes.
- Patients requiring extraction of upper posterior teeth will be recruited.
Who cannot join
- Healthy subjects with intact sockets after extraction.
- Normal mouth opening and good oral hygiene.
- No systemic conditions affecting bone healing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Muataz A Karimeh, Bachelor, 00201027988331, moataz.karema1998@gmail.com
Mohammed M Hussein, MD
About this study
Official title: Clinical and Radiographic Evaluation of the Effect of Thymoquinone 0.2% Gel on Bone Density, Bone Width, and Socket Preservation After Tooth Extraction
This study aims to evaluate the clinical and radiographic effects of 0.2% Thymoquinone gel on bone density, bone width, and socket preservation after tooth extraction.
Read the detailed description
Tooth extraction triggers a cascade of biological events which lead to significant remodeling of the alveolar ridge, frequently resulting in reductions in both bone width and height.
The concept of alveolar ridge preservation (ARP) has developed to address the bone resorption that follows extraction. ARP aims to maintain ridge dimensions and reduce the need for further augmentation before implant placement.
Among these, the small-molecule Thymoquinone (TQ), derived from Nigella sativa, has demonstrated significant osteogenic, anti-inflammatory, and antioxidant effects in preclinical studies.
- Conditions
- Radiographic Evaluation, Bone Density, Bone Width, Socket Preservation, Tooth Extraction, Thymoquinone
- Being tested
- Gel foam, Thymoquinone gel + gel foam, Nano-formulated 0.2% thymoquinone gel + gel foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel foamDrug
Patients will receive gel foam only.
Thymoquinone gel + gel foamDrug
Patients will receive 0.2% thymoquinone gel + gel foam.
Nano-formulated 0.2% thymoquinone gel + gel foamDrug
Patients will receive nano-formulated 0.2% thymoquinone gel + gel foam.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Negative Control) | Active comparator | Patients will receive gel foam only Receives: Drug: Gel foam |
| Group II (Study Group 1) | Experimental | Patients will receive 0.2% thymoquinone gel + gel foam. Receives: Drug: Thymoquinone gel + gel foam |
| Group III (Study Group 2, Nano) | Experimental | Patients will receive nano-formulated 0.2% thymoquinone gel + gel foam. Receives: Drug: Nano-formulated 0.2% thymoquinone gel + gel foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar bone density after tooth extraction
Alveolar bone density will be assessed radiographically using cone-beam computed tomography (CBCT). The change in bone density from baseline to the specified postoperative assessment will be compared.
Measured: 3 months after tooth extraction
Secondary outcomes (2)
Change in alveolar bone width after tooth extraction
Alveolar bone width will be assessed radiographically using cone-beam computed tomography (CBCT). The change in alveolar ridge width from baseline to the postoperative assessment will be measured.
Measured: 3 months after tooth extraction
Change in alveolar ridge dimension after tooth extraction
Alveolar ridge dimensions will be assessed radiographically using cone-beam computed tomography (CBCT). Changes in the dimensions of the alveolar ridge following tooth extraction will be measured and compared.
Measured: 3 months after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiographic EvaluationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muataz Adnan Karimeh, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765745
- Sponsor's protocol ID
- KFSIRB200-852
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Effect of Thymoquinone 0.2% Gel on Bone Density, Bone Width, and Socket Preservation After Tooth Extraction
- ClinicalTrials.gov ID
- NCT07765745
- Acronym / sponsor ID
- KFSIRB200-852
- Conditions
- Radiographic Evaluation, Bone Density, Bone Width, Socket Preservation, Tooth Extraction, Thymoquinone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 Aug 2026 (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.
This study aims to evaluate the clinical and radiographic effects of 0.2% Thymoquinone gel on bone density, bone width, and socket preservation after tooth extraction.
Detailed description
Tooth extraction triggers a cascade of biological events which lead to significant remodeling of the alveolar ridge, frequently resulting in reductions in both bone width and height.
The concept of alveolar ridge preservation (ARP) has developed to address the bone resorption that follows extraction. ARP aims to maintain ridge dimensions and reduce the need for further augmentation before implant placement.
Among these, the small-molecule Thymoquinone (TQ), derived from Nigella sativa, has demonstrated significant osteogenic, anti-inflammatory, and antioxidant effects in preclinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Negative Control) | Active comparator | Drug: Gel foamPatients will receive gel foam only |
| Group II (Study Group 1) | Experimental | Drug: Thymoquinone gel + gel foamPatients will receive 0.2% thymoquinone gel + gel foam. |
| Group III (Study Group 2, Nano) | Experimental | Drug: Nano-formulated 0.2% thymoquinone gel + gel foamPatients will receive nano-formulated 0.2% thymoquinone gel + gel foam. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-50 years.
- Both sexes.
- Patients requiring extraction of upper posterior teeth will be recruited.
Key exclusion criteria (3 listed)
- Healthy subjects with intact sockets after extraction.
- Normal mouth opening and good oral hygiene.
- No systemic conditions affecting bone healing.
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 |
|---|---|---|
| Gel foamPatients will receive gel foam only. | Drug | Group I (Negative Control) |
| Thymoquinone gel + gel foamPatients will receive 0.2% thymoquinone gel + gel foam. | Drug | Group II (Study Group 1) |
| Nano-formulated 0.2% thymoquinone gel + gel foamPatients will receive nano-formulated 0.2% thymoquinone gel + gel foam. | Drug | Group III (Study Group 2, Nano) |
Primary outcome
Change in alveolar bone density after tooth extraction
Time frame: 3 months after tooth extraction
Alveolar bone density will be assessed radiographically using cone-beam computed tomography (CBCT). The change in bone density from baseline to the specified postoperative assessment will be compared.
2 secondary outcomes
Change in alveolar bone width after tooth extraction
Time frame: 3 months after tooth extraction
Change in alveolar ridge dimension after tooth extraction
Time frame: 3 months after tooth extraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel foam, Thymoquinone gel + gel foam and Nano-formulated 0.2% thymoquinone gel + gel foam in people with Radiographic Evaluation and Bone Density, run by Kafrelsheikh 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 3 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muataz A Karimeh, Bachelor (00201027988331, moataz.karema1998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alveolar bone density after tooth extraction (time frame: 3 months after tooth extraction). 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 14 Aug 2026.