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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
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cyst, Jaw

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 15, 2023
    Last Updated
    May 15, 2023
    Sponsor
    Fayoum University
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    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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