Coenzyme Q10 and Dentoalveolar Cyst
Primary Purpose
Cyst, Jaw
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Coenzyme Q10
control group
Sponsored by

About this trial
This is an interventional treatment trial for Cyst, Jaw
Eligibility Criteria
Inclusion Criteria: Adult patients with critical-size jaw cysts Medically stable No cystic lesion recurrence Exclusion Criteria: Cystic lesion recurrence Medical problem
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
coenzyme group
control group
Arm Description
Outcomes
Primary Outcome Measures
bone density
measure the bone density of new bone in the cystic cavity at 6 months by cone beam CT
Secondary Outcome Measures
bone volume
measure the bone volume in the defect by cone beam CT at 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05873673
Brief Title
Coenzyme Q10 and Dentoalveolar Cyst
Official Title
The Effect of Coenzyme Q10 on Bone Regeneration in Jaw Defect After Cyst Enculation: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 11, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Bone density and volume will be assessed by cone beam CT immediately postoperative and 6months later for all patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyst, Jaw
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
coenzyme group
Arm Type
Active Comparator
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10
Intervention Description
cystic jaw defect filled with coenzyme Q10 gel
Intervention Type
Drug
Intervention Name(s)
control group
Intervention Description
cystic jaw defect filled with placebo gel
Primary Outcome Measure Information:
Title
bone density
Description
measure the bone density of new bone in the cystic cavity at 6 months by cone beam CT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
bone volume
Description
measure the bone volume in the defect by cone beam CT at 6 months
Time Frame
6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with critical-size jaw cysts
Medically stable
No cystic lesion recurrence
Exclusion Criteria:
Cystic lesion recurrence
Medical problem
12. IPD Sharing Statement
Learn more about this trial
Coenzyme Q10 and Dentoalveolar Cyst
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