Coenzyme Q10NCT07045246
Effect of Co-enzyme Q10 on the Bone Volume of Alveolar Cleft Reconstruction
A study testing Coenzyme Q 10 and iliac bone graft in people with Coenzyme Q10 and Alveolar Cleft Grafting, run by Fayoum University at 1 site in Egypt.
Trial summary
Evaluate the effect of Co-enzyme Q10 on the bone volume in unilateral alveolar cleft repair Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Coenzyme Q10, Alveolar Cleft Grafting
- What is being tested?
- Coenzyme Q 10 and iliac bone graft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age ranged between 10-14 years, with good oral hygiene and general good health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mennat Allah Sayed Ibrahim Ali Demonstrator, Oral and Maxillofacial Surgery Department contact
Haytham Ahmed Elmahlawy professor, oral and maxillofacial surgery department contact
About this study
Official title: The Evaluation of the Effect of Co-enzyme Q10 on the Bone Volume of Alveolar Cleft Reconstruction (Randomized Clinical Trial)
Evaluate the effect of Co-enzyme Q10 on the bone volume in unilateral alveolar cleft repair
Read the detailed description
Cleft lip or palate is the most frequent congenital abnormality, accounting for about 0.3/1000 live births in Egypt and 1/ 500-1000 live births worldwide. In 75% of patients, cleft lip and palate are accompanied by an alveolar cleft. Alveolar cleft reconstruction is needed to conserve the continuity of the arch, provide the maximum amount of bone support for the nose and permanent teeth eruption, and repair the residual oro-antral fistula. Alveolar cleft grafting is performed at various ages, but secondary grafting, performed between the ages of 9 and 12, is the most suitable and advantageous. Due to its osteogenic, osteoinductive, and osteoconductive properties, the autogenous iliac bone graft is considered the "gold standard" for alveolar cleft repair. However, the autogenous iliac bone graft is associated with a graft resorption rate of about 15-24% during the first six months. In order to resolve those complications, different substances were combined with the iliac graft, such as platelet-rich plasma (PRP), fibrin glue, or bone morphogenic protein (BMP). Nevertheless, it was demonstrated that there was no difference between iliac grafts with or without these materials. Various graft materials, such as allograft, xenograft, and synthetic bone grafts, have been utilized as an alternative to autogenous bone grafts. Allografts are expensive and associated with risks of bacterial contamination, viral transmission, and immunogenicity. Conversely, the main drawbacks of synthetic bone grafts are slow resorption and brittleness. A combination of hydroxyapatite and b-tricalcium phosphate, along with an autogenous bone graft, has been used to address these drawbacks. Co-enzyme Q10 is a lipid-soluble vitamin-like compound present in the inner membrane of the mitochondria of every cell of the body. The structure of Coenzyme Q10 consists of a benzoquinone ring and a lipophilic isoprenoid side chain with ten isoprenyl units in the case of humans, which determines its low polarity and allows its fast diffusion through mitochondrial membrane. Recently, Coenzyme Q10 has gained attention for its therapeutic application for several disorders including cardiovascular diseases, inflammation, human fertility, and diabetes mellitus. Co-enzyme Q10 provides membrane stabilizing properties and acts as an antioxidant with cell-protective effect which acts as an inhibitor of RANKLinduced osteoclast differentiation and enhancer of bone-forming osteoblast differentiation. Co-enzyme Q10 leads to a decreased TRAP+ MNCs formation, as well as dose-dependent down regulation of gene expressions, NFATc1, TRAP, and OSCAR, for osteoclast differentiation. Co-enzyme Q10 in high concentrations (over 10 µM) disturbed the production of ROS and attenuates the H2O2-induced early signaling activities including p38, IκBα, and JNK signaling pathways. Additionally, Co-enzyme Q10 furthered the induction of osteoblastogenic gene markers and also promoted matrix mineralization by enhancing bone nodule formation. Co-enzyme Q10 treatment is safe, even at the highest doses. Most clinical trials have not reported significant adverse effects that necessitated stopping therapy. It undergoes biotransformation in the liver and is eliminated primarily via the biliary tract; therefore it can accumulate in patients with hepatic impairment or biliary obstruction. Many studies used Co-enzyme Q10 in bone augmentation and socket preservation. The use of Co-enzyme Q10 enhances the bone quality and decreases the rate of bone resorption. No study has investigated the effect of the Co-enzyme Q10 in the reconstruction of the alveolar cleft, despite its role in bone healing. Consequently, the present study targeted to assess the significance of Co-enzyme Q10 on the quality and quantity of bone formation in unilateral alveolar cleft repair
- Conditions
- Coenzyme Q10, Alveolar Cleft Grafting
- Being tested
- Coenzyme Q 10, iliac bone graft
- Keywords
- alveolar cleft reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q 10Procedure or surgery
Patients received Coenzyme Q 10 as a graft material in unilateral maxillary alveolar cleft
iliac bone graftProcedure or surgery
iliac bone used as a graft for alveolar cleft reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Iliac bone graft | Active comparator | In 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. Receives: Procedure: iliac bone graft |
| CoQ10 graft | Active comparator | the Co-enzyme Q10 will be packed into the alveolar cleft defect alone Receives: Procedure: Coenzyme Q 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months postoperative
Secondary outcomes (2)
bone density
the average bone density will be measured from the CBCT
Measured: 6 months postoperative
bone formation ratio
BF% = (formed volume/alveolar defect) ×100%
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coenzyme Q10Studies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Sayed Ibrahim Ali, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045246
- Sponsor's protocol ID
- CoQ10 in Cleft Reconstruction
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37794139
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effect of Co-enzyme Q10 on the Bone Volume of Alveolar Cleft Reconstruction (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07045246
- Acronym / sponsor ID
- CoQ10 in Cleft Reconstruction
- Conditions
- Coenzyme Q10, Alveolar Cleft Grafting
- Keywords
- alveolar cleft reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the effect of Co-enzyme Q10 on the bone volume in unilateral alveolar cleft repair
Detailed description
Cleft lip or palate is the most frequent congenital abnormality, accounting for about 0.3/1000 live births in Egypt and 1/ 500-1000 live births worldwide. In 75% of patients, cleft lip and palate are accompanied by an alveolar cleft. Alveolar cleft reconstruction is needed to conserve the continuity of the arch, provide the maximum amount of bone support for the nose and permanent teeth eruption, and repair the residual oro-antral fistula. Alveolar cleft grafting is performed at various ages, but secondary grafting, performed between the ages of 9 and 12, is the most suitable and advantageous. Due to its osteogenic, osteoinductive, and osteoconductive properties, the autogenous iliac bone graft is considered the "gold standard" for alveolar cleft repair. However, the autogenous iliac bone graft is associated with a graft resorption rate of about 15-24% during the first six months. In order to resolve those complications, different substances were combined with the iliac graft, such as platelet-rich plasma (PRP), fibrin glue, or bone morphogenic protein (BMP). Nevertheless, it was demonstrated that there was no difference between iliac grafts with or without these materials. Various graft materials, such as allograft, xenograft, and synthetic bone grafts, have been utilized as an alternative to autogenous bone grafts. Allografts are expensive and associated with risks of bacterial contamination, viral transmission, and immunogenicity. Conversely, the main drawbacks of synthetic bone grafts are slow resorption and brittleness. A combination of hydroxyapatite and b-tricalcium phosphate, along with an autogenous bone graft, has been used to address these drawbacks. Co-enzyme Q10 is a lipid-soluble vitamin-like compound present in the inner membrane of the mitochondria of every cell of the body. The structure of Coenzyme Q10 consists of a benzoquinone ring and a lipophilic isoprenoid side chain with ten isoprenyl units in the case of humans, which determines its low polarity and allows its fast diffusion through mitochondrial membrane. Recently, Coenzyme Q10 has gained attention for its therapeutic application for several disorders including cardiovascular diseases, inflammation, human fertility, and diabetes mellitus. Co-enzyme Q10 provides membrane stabilizing properties and acts as an antioxidant with cell-protective effect which acts as an inhibitor of RANKLinduced osteoclast differentiation and enhancer of bone-forming osteoblast differentiation. Co-enzyme Q10 leads to a decreased TRAP+ MNCs formation, as well as dose-dependent down regulation of gene expressions, NFATc1, TRAP, and OSCAR, for osteoclast differentiation. Co-enzyme Q10 in high concentrations (over 10 µM) disturbed the production of ROS and attenuates the H2O2-induced early signaling activities including p38, IκBα, and JNK signaling pathways. Additionally, Co-enzyme Q10 furthered the induction of osteoblastogenic gene markers and also promoted matrix mineralization by enhancing bone nodule formation. Co-enzyme Q10 treatment is safe, even at the highest doses. Most clinical trials have not reported significant adverse effects that necessitated stopping therapy. It undergoes biotransformation in the liver and is eliminated primarily via the biliary tract; therefore it can accumulate in patients with hepatic impairment or biliary obstruction. Many studies used Co-enzyme Q10 in bone augmentation and socket preservation. The use of Co-enzyme Q10 enhances the bone quality and decreases the rate of bone resorption. No study has investigated the effect of the Co-enzyme Q10 in the reconstruction of the alveolar cleft, despite its role in bone healing. Consequently, the present study targeted to assess the significance of Co-enzyme Q10 on the quality and quantity of bone formation in unilateral alveolar cleft repair
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iliac bone graft | Active comparator | Procedure: iliac bone graftIn 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 comparator | Procedure: Coenzyme Q 10the Co-enzyme Q10 will be packed into the alveolar cleft defect alone |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- age ranged between 10-14 years, with good oral hygiene and general good health
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q 10Patients received Coenzyme Q 10 as a graft material in unilateral maxillary alveolar cleft | Procedure or surgery | CoQ10 graft |
| iliac bone graftiliac bone used as a graft for alveolar cleft reconstruction | Procedure or surgery | Iliac bone graft |
Primary outcome
bone volume
Time frame: 6 months postoperative
V= (A1xT) + (A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of Slices
2 secondary outcomes
bone density
Time frame: 6 months postoperative
bone formation ratio
Time frame: 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Results publication: PubMed 37794139Shabaan 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mennat Allah Sayed Ibrahim Ali Demonstrator, Oral and Maxillofacial Surgery Department contact
Haytham Ahmed Elmahlawy professor, oral and maxillofacial surgery department contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q 10 and iliac bone graft in people with Coenzyme Q10 and Alveolar Cleft Grafting, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mennat Allah Sayed Ibrahim Ali Demonstrator, Oral and Maxillofacial Surgery Department (00201000362754, msi12@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone volume (time frame: 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.