ClinicalTrials.gg
Status unknownNCT03213769Updated Jul 11, 2017

Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer

An interventional study of topical coenzyme Q10 gel and Carpabol gel in Oral Aphthous Ulcer, sponsored by Cairo University. Status unknown. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Oral Aphthous Ulcer

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Keywords

  • oral minor aphthous ulcer
  • topical Q10 gel
  • topical antioxidant
  • oral recurrent aphthous ulcer
  • oral aphthous stomatitis
03

In context

Foot-and-Mouth Disease

7 studies on the registry are indexed under Foot-and-Mouth Disease; 2 are open to participants now.

Browse Foot-and-Mouth Disease studies →

Lead sponsor

Cairo University is the lead sponsor of 4,951 studies on the registry; 1,463 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 and other therapy.
  • Patients treated with any oral topical medications 48h before the study27.
  • Pregnant and lactating mothers.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (estimated)

Study arms

  • Active comparator
    topical coenzyme Q10 gel

    Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.

    Drug: topical coenzyme Q10 gel

  • Placebo comparator
    carbapol gel

    placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.

    Drug: Carpabol gel

Interventions

  • Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.

  • DrugCarpabol gel

    placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.

06

What researchers measure

Primary outcomes

  1. visual analogue scale

    pain

    Time frame: 7 days

Secondary outcomes

  1. scoring system(0-3)

    Erythema surround lesion

    Time frame: 7 days

  2. cross sectional area William periodontal probe/mm

    Cross sectional area

    Time frame: 7 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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 20569032 ↗
  • Scully 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 16155535 ↗
  • Momen-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 20173724 ↗
  • Littarru 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 17914161 ↗
  • Tarakji 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 26028911 ↗
  • Prakash 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 21189900 ↗
  • Preeti 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 22144824 ↗
  • Hamdy 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2017; primary completion for Jul 2018, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2017
First posted
Jul 11, 2017
StartEst.
Jul 2017
Primary completionEst.
Jul 2018
CompletionEst.
Jul 2018
Last update
Jul 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03213769
Lead sponsor
Cairo University
Responsible party
Mostafa Abdelsamie Bakry Nafie (Principal investigator, Cairo University) — Principal investigator
First posted
Jul 11, 2017
Start date
Jul 2017 (estimated)
Primary completion
Jul 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Jul 11, 2017

Study contacts

mostafa abdelsamie nafie, master
Contact
mostafa.abdelsamie@dentistry.cu.edu.eg
+201004165905
Amal Ali, lecturer
Contact
amal_ali.2009@yahoo.com
+201005204628
fatheya zahran, professor
study director · faculty of dentistry -CairoU

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Coenzyme Q10

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