Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

NCT04265001 | Completed Phase 3

• 1 other identifier: Mai Zakaria Ibrahium
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Aphthous Stomatitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain 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.

  one week

Secondary Outcomes (2)

• Ulcer size

  one week

• Duration of healing

  one week

Study Arms (2)

Control group

ACTIVE COMPARATOR

Topical cholrhexidine hydrochloride 125 mg/100 ml available commercially (Hexitol; Arab Drug Company for Pharmaceutical and Chemical Industries, Cairo, Egypt) mouthwash. Topical cholrhexidine hydrochloride mouthwash treatment has been repeated three times per day for one week.

Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash

Hyaluronic acid group (HA group)

EXPERIMENTAL

Topical hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash (Aftamed; Bioplaxpharma, UK).Topical hyaluronic acid mouthwash treatment has been repeated three times per day for one week.

Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash

Interventions

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

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

Also known as: (Aftamed; Bioplaxpharma, UK)

Control group; Hyaluronic acid group (HA group)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-30 years.
• Minimum of 2 years of RAS history, with active ulcer less than 48 hours of recurrent aphthous stomatitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 115, Egypt

Location

MeSH Terms

Conditions

Stomatitis, Aphthous; Pain

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 11, 2020
• Study Start: November 1, 2019
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)