- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05873673
Coenzyme Q10 and Dentoalveolar Cyst
February 26, 2025 updated by: Shaimaa Mohsen, Fayoum University
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Fayoum, Egypt, 02
- Fayoum University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult patients with critical-size jaw cysts
- Medically stable
- No cystic lesion recurrence
Exclusion Criteria:
- Cystic lesion recurrence
- Medical problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: control group
|
cystic jaw defect filled with placebo gel
|
|
Active Comparator: coenzyme group
|
cystic jaw defect filled with coenzyme Q10 gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone density
Time Frame: 6 months
|
measure the bone density of new bone in the cystic cavity at 6 months by cone beam CT
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone volume
Time Frame: 6months
|
measure the bone volume in the defect by cone beam CT at 6 months
|
6months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 11, 2023
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
May 15, 2023
First Submitted That Met QC Criteria
May 15, 2023
First Posted (Actual)
May 24, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 (Mobile Health and Wellness Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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