Oral Aphthous UlcerNCT03213769
Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
A study testing topical coenzyme Q10 gel and Carpabol gel in people with Oral Aphthous Ulcer, run by Cairo University.
Trial summary
Recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10 gel to treat the lesion and more safe for the participants. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Aphthous Ulcer
- What is being tested?
- topical coenzyme Q10 gel and Carpabol gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with free medical history and no systemic diseases16.
- Patients clinically diagnosed as suffering from symptomatic oral minor aphthous ulcers.
- Patients who agreed to take medications.
Who cannot join
- Patients suffering from any systemic disease as Crohn's disease, Behcet's disease and others.
- Anemic and leukemic patients (using complete blood count investigation)
- Patients taking systemic drugs such as systemic steroids and other immunosuppressive therapy.
- Patients treated with any oral topical medications 48h before the study27.
- Pregnant and lactating mothers.
Trial locations and contacts
No sites are listed yet.
About this study
Recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10 gel to treat the lesion and more safe for the participants.
Read the detailed description
Double randomized clinical trial study using two parallel group suffer from oral aphthous ulcer one take antioxidant topical q10gel and other group take placebo carpabol gel two times per day for seven days measuring outcome at fourth and seventh day including pain; healing period and clinical parameters.
Sample size of study include 26 in each group.
- Conditions
- Oral Aphthous Ulcer
- Being tested
- topical coenzyme Q10 gel, Carpabol gel
- Keywords
- oral minor aphthous ulcer, topical Q10 gel, topical antioxidant, oral recurrent aphthous ulcer, oral aphthous stomatitis
- Medical subject headings
- Foot-and-Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical coenzyme Q10 gelDrug
Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.
Carpabol gelDrug
placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| topical coenzyme Q10 gel | Active comparator | Q10 gel will give 2 times /day after breakfast and evening meal for 7 days. Receives: Drug: topical coenzyme Q10 gel |
| carbapol gel | Placebo comparator | placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days. Receives: Drug: Carpabol gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
pain
Measured: 7 days
Secondary outcomes (2)
scoring system(0-3)
Erythema surround lesion
Measured: 7 days
cross sectional area William periodontal probe/mm
Cross sectional area
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Oral Aphthous UlcerStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- controlled randimized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Abdelsamie Bakry Nafie, Cairo University
- Investigators
- fatheya zahran, professor, Study director, faculty of dentistry -CairoU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213769
- Sponsor's protocol ID
- 1990
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sawair FA. Recurrent aphthous stomatitis: do we know what patients are using to treat the ulcers? J Altern Complement Med. 2010 Jun;16(6):651-5. doi: 10.1089/acm.2009.0555.
PubMed 20569032Scully C, Felix DH. Oral medicine--update for the dental practitioner. Aphthous and other common ulcers. Br Dent J. 2005 Sep 10;199(5):259-64. doi: 10.1038/sj.bdj.4812649.
PubMed 16155535Momen-Beitollahi J, Mansourian A, Momen-Heravi F, Amanlou M, Obradov S, Sahebjamee M. Assessment of salivary and serum antioxidant status in patients with recurrent aphthous stomatitis. Med Oral Patol Oral Cir Bucal. 2010 Jul 1;15(4):e557-61. doi: 10.4317/medoral.15.e557.
PubMed 20173724Littarru GP, Tiano L. Bioenergetic and antioxidant properties of coenzyme Q10: recent developments. Mol Biotechnol. 2007 Sep;37(1):31-7. doi: 10.1007/s12033-007-0052-y.
PubMed 17914161Tarakji B, Gazal G, Al-Maweri SA, Azzeghaiby SN, Alaizari N. Guideline for the diagnosis and treatment of recurrent aphthous stomatitis for dental practitioners. J Int Oral Health. 2015 May;7(5):74-80.
PubMed 26028911Prakash S, Sunitha J, Hans M. Role of coenzyme Q(10) as an antioxidant and bioenergizer in periodontal diseases. Indian J Pharmacol. 2010 Dec;42(6):334-7. doi: 10.4103/0253-7613.71884.
PubMed 21189900Preeti L, Magesh K, Rajkumar K, Karthik R. Recurrent aphthous stomatitis. J Oral Maxillofac Pathol. 2011 Sep;15(3):252-6. doi: 10.4103/0973-029X.86669.
PubMed 22144824Hamdy AA, Ibrahem MA. Management of aphthous ulceration with topical quercetin: a randomized clinical trial. J Contemp Dent Pract. 2010 Jul 1;11(4):E009-16.
PubMed 20953559
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
- ClinicalTrials.gov ID
- NCT03213769
- Acronym / sponsor ID
- 1990
- Conditions
- Oral Aphthous Ulcer
- Keywords
- oral minor aphthous ulcer, topical Q10 gel, topical antioxidant, oral recurrent aphthous ulcer, oral aphthous stomatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 11 Jul 2017 (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.
Recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10 gel to treat the lesion and more safe for the participants.
Detailed description
Double randomized clinical trial study using two parallel group suffer from oral aphthous ulcer one take antioxidant topical q10gel and other group take placebo carpabol gel two times per day for seven days measuring outcome at fourth and seventh day including pain; healing period and clinical parameters.
Sample size of study include 26 in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- controlled randimized clinical trial
| Arm | Type | Receives |
|---|---|---|
| topical coenzyme Q10 gel | Active comparator | Drug: topical coenzyme Q10 gelQ10 gel will give 2 times /day after breakfast and evening meal for 7 days. |
| carbapol gel | Placebo comparator | Drug: Carpabol gelplacebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with free medical history and no systemic diseases16.
- Patients clinically diagnosed as suffering from symptomatic oral minor aphthous ulcers.
- Patients who agreed to take medications.
Key exclusion criteria (5 listed)
- Patients suffering from any systemic disease as Crohn's disease, Behcet's disease and others.
- Anemic and leukemic patients (using complete blood count investigation)
- Patients taking systemic drugs such as systemic steroids and other immunosuppressive therapy.
- Patients treated with any oral topical medications 48h before the study27.
- Pregnant and lactating mothers.
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 |
|---|---|---|
| topical coenzyme Q10 gelQ10 gel will give 2 times /day after breakfast and evening meal for 7 days. | Drug | topical coenzyme Q10 gel |
| Carpabol gelplacebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days. | Drug | carbapol gel |
Primary outcome
visual analogue scale
Time frame: 7 days
pain
2 secondary outcomes
scoring system(0-3)
Time frame: 7 days
cross sectional area William periodontal probe/mm
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Background: PubMed 20569032Sawair FA. Recurrent aphthous stomatitis: do we know what patients are using to treat the ulcers? J Altern Complement Med. 2010 Jun;16(6):651-5. doi: 10.1089/acm.2009.0555.
- Background: PubMed 16155535Scully C, Felix DH. Oral medicine--update for the dental practitioner. Aphthous and other common ulcers. Br Dent J. 2005 Sep 10;199(5):259-64. doi: 10.1038/sj.bdj.4812649.
- Background: PubMed 20173724Momen-Beitollahi J, Mansourian A, Momen-Heravi F, Amanlou M, Obradov S, Sahebjamee M. Assessment of salivary and serum antioxidant status in patients with recurrent aphthous stomatitis. Med Oral Patol Oral Cir Bucal. 2010 Jul 1;15(4):e557-61. doi: 10.4317/medoral.15.e557.
- Background: PubMed 17914161Littarru GP, Tiano L. Bioenergetic and antioxidant properties of coenzyme Q10: recent developments. Mol Biotechnol. 2007 Sep;37(1):31-7. doi: 10.1007/s12033-007-0052-y.
- Background: PubMed 26028911Tarakji B, Gazal G, Al-Maweri SA, Azzeghaiby SN, Alaizari N. Guideline for the diagnosis and treatment of recurrent aphthous stomatitis for dental practitioners. J Int Oral Health. 2015 May;7(5):74-80.
- Background: PubMed 21189900Prakash S, Sunitha J, Hans M. Role of coenzyme Q(10) as an antioxidant and bioenergizer in periodontal diseases. Indian J Pharmacol. 2010 Dec;42(6):334-7. doi: 10.4103/0253-7613.71884.
- Background: PubMed 22144824Preeti L, Magesh K, Rajkumar K, Karthik R. Recurrent aphthous stomatitis. J Oral Maxillofac Pathol. 2011 Sep;15(3):252-6. doi: 10.4103/0973-029X.86669.
- Background: PubMed 20953559Hamdy AA, Ibrahem MA. Management of aphthous ulceration with topical quercetin: a randomized clinical trial. J Contemp Dent Pract. 2010 Jul 1;11(4):E009-16.
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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. This study is not recruiting at the moment.
fatheya zahran, professor study director
faculty of dentistry -CairoU
Questions about this trial
What is this clinical trial studying?
A study testing topical coenzyme Q10 gel and Carpabol gel in people with Oral Aphthous Ulcer, run by Cairo University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mostafa abdelsamie nafie, master (+201004165905, mostafa.abdelsamie@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: 7 days). 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 NCT03213769, which also lists 8 linked publications.
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 11 Jul 2017.