NCT05873673

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

June 11, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

May 15, 2023

Last Update Submit

February 26, 2025

Conditions

Cyst, Jaw

Outcome Measures

Primary Outcomes (1)

  • bone density

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

    6 months

Secondary Outcomes (1)

  • bone volume

    6months

Study Arms (2)

coenzyme group

ACTIVE COMPARATOR
Drug: Coenzyme Q10

control group

PLACEBO COMPARATOR
Drug: control group

Interventions

Coenzyme Q10DRUG

cystic jaw defect filled with coenzyme Q10 gel

coenzyme group
control groupDRUG

cystic jaw defect filled with placebo gel

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cystic lesion recurrence
  • Medical problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, 02, Egypt

Location

MeSH Terms

Conditions

Jaw Cysts

Interventions

coenzyme Q10Control Groups

Condition Hierarchy (Ancestors)

Bone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

June 11, 2023

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

EG(1)