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Completed

NCT Number: NCT04884464

Hyaluronic Acid in Counteracting Aphthous Stomatitis

Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive gel over the lesions seems to have potential in terms of efficacy and the avoidance of side effects. Of course, hyaluronic acid-based formulations show different effects and tolerability. In this retrospective observational study, the results obtained using a hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will be reported.

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Key information

Conditions

Aphthous Stomatitis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Oral Ulcer Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University fo Urbino Carlo Bo

Urbino, 61029, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of aphthous stomatitis
  • Healthy for other conditions excluding aphthous stomatitis

Exclusion criteria

  • Taking one of the following in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotic, antifungal, hormone therapy (including birth control pills).

Treatment and study plan

Hyaluronic acid-based gel

Device

Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks

Chlorhexidine gluconate

Drug

Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks

Primary outcomes

  1. Change in number of oral lesions

    Time frame: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14

    Change from baseline (Day 1) to Day 14 in the number of oral lesions observed in the two groups

  2. Change in size of oral lesions

    Time frame: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14

    Change from baseline (Day 1) to Day 14 in the size (mm) of oral lesions observed in the two groups

Secondary outcomes

  1. Compliance to treatment

    Time frame: From Day 1 to Day 14

    Number of daily treatments completed, timing of treatment application (hour of the day)

  2. Side effects to treatment

    Time frame: From Day 1 to Day 14

    Dosage Record Treatment Emergent Symptom Scale (DOTES). It uses a Likert scale, going from 1 (no side effects) to 4 (severe side effects).

Sponsors and collaborators

Lead sponsor

University of Urbino "Carlo Bo"

Other

Registry information

Official study title

Clinical Evaluation of a Hyaluronic Acid-based Medical Device in Counteracting Aphthous Stomatitis in Adults

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 13, 2021
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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