Cyst, JawPhase 2NCT05873673
Coenzyme Q10 and Dentoalveolar Cyst
A Phase 2 study testing Coenzyme Q10 in people with Cyst, Jaw, run by Fayoum University at 1 site in Egypt.
Trial summary
10 patients in each group will undergo cyst removal under local anesthesia. After cyst removal, the cystic cavity will be filled with placebo gel in the control group or coenzyme gel in the coenzyme group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cyst, Jaw
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2023to 1 Apr 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with critical-size jaw cysts
- Medically stable
- No cystic lesion recurrence
Who cannot join
- Cystic lesion recurrence
- Medical problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Coenzyme Q10 on Bone Regeneration in Jaw Defect After Cyst Enculation: A Randomized Controlled Clinical Trial
10 patients in each group will undergo cyst removal under local anesthesia. After cyst removal, the cystic cavity will be filled with placebo gel in the control group or coenzyme gel in the coenzyme group.
Bone density and volume will be assessed by cone beam CT immediately postoperative and 6months later for all patients
- Conditions
- Cyst, Jaw
- Being tested
- Coenzyme Q10, control group
- Medical subject headings
- Jaw Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
cystic jaw defect filled with coenzyme Q10 gel
control groupDrug
cystic jaw defect filled with placebo gel
| Study group | Role | What they receive |
|---|---|---|
| coenzyme group | Active comparator | Not described Receives: Drug: Coenzyme Q10 |
| control group | Placebo comparator | Not described Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone density
measure the bone density of new bone in the cystic cavity at 6 months by cone beam CT
Measured: 6 months
Secondary outcomes (1)
bone volume
measure the bone volume in the defect by cone beam CT at 6 months
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start11 Jun 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyst, JawStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873673
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2025
- First submitted
- 15 May 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coenzyme Q10 on Bone Regeneration in Jaw Defect After Cyst Enculation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05873673
- Acronym / sponsor ID
- 1
- Conditions
- Cyst, Jaw
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 11 Jun 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 24 May 2023 (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.
10 patients in each group will undergo cyst removal under local anesthesia. After cyst removal, the cystic cavity will be filled with placebo gel in the control group or coenzyme gel in the coenzyme group.
Bone density and volume will be assessed by cone beam CT immediately postoperative and 6months later for all patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coenzyme group | Active comparator | Drug: Coenzyme Q10 |
| control group | Placebo comparator | Drug: control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with critical-size jaw cysts
- Medically stable
- No cystic lesion recurrence
Key exclusion criteria (2 listed)
- Cystic lesion recurrence
- Medical problem
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 |
|---|---|---|
| Coenzyme Q10cystic jaw defect filled with coenzyme Q10 gel | Drug | coenzyme group |
| control groupcystic jaw defect filled with placebo gel | Drug | control group |
Primary outcome
bone density
Time frame: 6 months
measure the bone density of new bone in the cystic cavity at 6 months by cone beam CT
1 secondary outcome
bone volume
Time frame: 6months
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 3 Mar 2025.
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Low-Intensity Pulsed Ultrasound as an Adjunctive Therapy for Bone Regeneration Following Jaw Cyst Enucleation
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Using of Bone Marrow Stem Cell Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Reconstruction of Upper Jaw Bony Cystic Defects, Comparing with Platelet Rich Fibrin with Bone Graft
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Coenzyme Q10 in people with Cyst, Jaw, run by Fayoum 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 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2025. 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?
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?
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?
bone density (time frame: 6 months). 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 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.