Hyaluronic Acid in Counteracting Aphthous Stomatitis

NCT04884464 | Completed

• 1 other identifier: UniUrb_HyalAcid_2021
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aphthous Stomatitis

Keywords

mucositis; oral ulcers; chlorhexidine; aloe barbadensis; rosa damascena

Outcome Measures

Primary Outcomes (2)

• Change in number of oral lesions

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

  Day 1; Day 3; Day 6; Day 9; Day 12; Day 14

• Change in size of oral lesions

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

  Day 1; Day 3; Day 6; Day 9; Day 12; Day 14

Secondary Outcomes (2)

• Compliance to treatment

  From Day 1 to Day 14

• Side effects to treatment

  From Day 1 to Day 14

Study Arms (2)

Hyaluronic acid-based gel

The composition of the gel, ranked by weight is: xylitol, glycerin, Rosa damascena petal extract, xanthan gum, polycarbophil, hyaluronic acid sodium salt (0.24%), pectin, potassium sorbate, sodium benzoate, panthenol, Aloe barbadensis leaf extract, stevia.

Device: Hyaluronic acid-based gel

Chlorhexidine gluconate

Chlorhexidine gluconate at a concentration of 0.2%.

Drug: Chlorhexidine Gluconate

Interventions

Hyaluronic acid-based gel DEVICE

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

Hyaluronic acid-based gel

Chlorhexidine Gluconate DRUG

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

Chlorhexidine gluconate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects without ethnic limitations, of both sexes and between the ages of 18 and 65, with a diagnosis of aphthous stomatitis, but considered otherwise healthy.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Urbino "Carlo Bo": lead

Study Sites (1)

University fo Urbino Carlo Bo

Urbino, 61029, Italy

Location

MeSH Terms

Conditions

Stomatitis, Aphthous; Mucositis; Oral Ulcer

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Davide Sisti, PhD

  University of Urbino "Carlo Bo"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 13, 2021
• Study Start: September 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)