Coenzyme Q10 and Dentoalveolar Cyst | NCT05873673

Studies
Coenzyme Q10 and Dentoalveolar Cyst

NCT05873673

Sponsor

Fayoum University

Status

Active, not recruiting

Last Update Posted

Mar 3, 2025Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Cyst, Jaw

Interventions

Coenzyme Q10
control group

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2023Actual

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Apr 1, 2025Estimated

First Submitted Date

May 15, 2023

First Submission Date that Met QC Criteria

May 15, 2023

First Posted Date

May 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Mar 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
coenzyme group	Active Comparator		Drug: Coenzyme Q10
control group	Placebo Comparator		Drug: control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coenzyme Q10	Drug	cystic jaw defect filled with coenzyme Q10 gel	coenzyme group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bone density	measure the bone density of new bone in the cystic cavity at 6 months by cone beam CT	6 months

Secondary Outcomes

Measure	Description	Time Frame
bone volume	measure the bone volume in the defect by cone beam CT at 6 months	6months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with critical-size jaw cysts
Medically stable
No cystic lesion recurrence

Exclusion Criteria:

Cystic lesion recurrence
Medical problem

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Fayoum University		Al Fayyum		02	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007570	Jaw Cysts

Ancestor Terms

ID	Term
D001845	Bone Cysts
D003560	Cysts
D009369	Neoplasms
D007571	Jaw Diseases
D009140

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C024989	coenzyme Q10
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided