Effect of Co-enzyme Q10 on the Bone Volume of Alveolar Cleft Reconstruction
The Evaluation of the Effect of Co-enzyme Q10 on the Bone Volume of Alveolar Cleft Reconstruction (Randomized Clinical Trial)
1 other identifier
interventional
12
1 country
1
Brief Summary
Evaluate the effect of Co-enzyme Q10 on the bone volume in unilateral alveolar cleft repair
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2025
CompletedFirst Posted
Study publicly available on registry
July 1, 2025
CompletedStudy Start
First participant enrolled
July 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedJuly 9, 2025
July 1, 2025
7 months
June 22, 2025
July 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone volume
V= (A1xT) + (A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of Slices
6 months postoperative
Secondary Outcomes (2)
bone density
6 months postoperative
bone formation ratio
6 months postoperative
Study Arms (2)
Iliac bone graft
ACTIVE COMPARATORIn the control group, A skin incision will be performed 1cm posterior to the anteriorsuperior iliac crest for iliac grafting. External oblique muscle and periosteum will be reflected medially to expose the anterior iliac crest. The cancellous graft will be gathered using trephine burs and surgical curettes after trap door fenestration reflection. The wound will be closed in three layers; muscle, subcutaneous, and skin. The cancellous bone will be packed to fill the alveolar defect in the control group.
CoQ10 graft
ACTIVE COMPARATORthe Co-enzyme Q10 will be packed into the alveolar cleft defect alone
Interventions
Patients received Coenzyme Q 10 as a graft material in unilateral maxillary alveolar cleft
iliac bone used as a graft for alveolar cleft reconstruction
Eligibility Criteria
You may qualify if:
- age ranged between 10-14 years, with good oral hygiene and general good health
You may not qualify if:
- patients with syndromes associated with an alveolar cleft, local pathosis at the maxilla that may interfere with surgery, previous grafting attempts, or cleft palate fistulae
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fayoum University, Faculty of Dentistry
Al Fayyum, Egypt
Related Publications (1)
Shabaan AA, Salahuddin A, Aboulmagd I, Ragab R, Salah KA, Rashid A, Ayad HM, El Aty Ahmed WA, Refahee SM. Alveolar cleft reconstruction using bone marrow aspirate concentrate and iliac cancellous bone: A 12-month randomized clinical study. Clin Oral Investig. 2023 Nov;27(11):6667-6675. doi: 10.1007/s00784-023-05276-9. Epub 2023 Oct 5.
PMID: 37794139BACKGROUND
Related Links
MeSH Terms
Interventions
Central Study Contacts
Mennat Allah Sayed Ibrahim Ali Demonstrator, Oral and Maxillofacial Surgery Department
CONTACT
Haytham Ahmed Elmahlawy professor, oral and maxillofacial surgery department
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Demonstrator, Oral and Maxillofacial Surgery Department
Study Record Dates
First Submitted
June 22, 2025
First Posted
July 1, 2025
Study Start
July 15, 2025
Primary Completion
February 15, 2026
Study Completion
April 1, 2026
Last Updated
July 9, 2025
Record last verified: 2025-07