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Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04265001
Enrollment
34
Registered
2020-02-11
Start date
2019-11-01
Completion date
2020-01-20
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Aphthous Stomatitis

Keywords

recurrent aphthous stomatitis, chlorhexidine, hyaluronic acid, pain, topical

Brief summary

This study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis

Detailed description

Recurrent aphthous stomatitis (RAS) is a common and widely recognized disorder involving the oral mucosa. It occurs typically as a single or multiple well-defined painful self-limiting ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red halo. The prevalence of RAS is up to 25% in the world population, with recurrence rate of 50% every 3 mouths. The exact cause of RAS is uncertain, and accordingly numerous components are as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic, immunological, and psychological factors.

Interventions

DRUGHyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash

Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

The inclusion criteria were as follows: * Age 18-30 years. * Minimum of 2 years of RAS history, with active ulcer less than 48 hours of recurrent aphthous stomatitis.

Exclusion criteria

* known history of hypersensitivities to Chlorhexidine or hyaluronic acid. * Use of any medication as a treatment for the present active ulcer. * Smoking and presence of systemic diseases such as Behçet disease, anemia, Crohn's disease, ulcerative colitis, acquired immune deficiency syndrome, and liver or kidney disease. * Pregnant or breast-feeding women. * Stomach ulcer, duodenal ulcer, and inflammation of the stomach or the esophagus. * Treatment with systemic nonsteroidal anti-inflammatory drugs, systemic steroids or other immune modulatory agents, oral antihistamines, or systemic antibiotics in the previous 3 months.

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreone weekPain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome) after irritation of the ulcer with the periodontal probe.

Secondary

MeasureTime frameDescription
Ulcer sizeone weekThe ulcer size was evaluated by determining the distance between two opposed boundaries of the ulcer edge, using a periodontal probe in millimeters.Score for clinical improvement of the sign where high values indicate worse outcome but low values indicate better outcome.
Duration of healingone weekperiod of the ulceration for complete healing

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026