Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers

NCT07121361 | Completed

• 1 other identifier: RA/0362820
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present research is to evaluate the efficacy of a gel formulation for a total treatment of 14 days for the treatment of traumatic or aphthous oral ulcers.

Conditions

Recurrent Aphthous Ulcer; Recurrent Aphthous Stomatitis

Keywords

Ulcers; Oral Hygiene; Oral care

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensity, measured using the VAS (Visual Analogue Scale), consisting of a 10 cm line, where 0 indicates no pain and 10 indicates intense pain.

  14 days

• Ulcers Dimensions

  Size of each ulcer measured through a sheet of clear plastic will be applied directly to the ulcer by tracing the circumference of the ulcer and then placed on a graph paper and the number of mm2 units included within the drawn area will be counted.

  14 days

Study Arms (2)

DNA mouthwash

ACTIVE COMPARATOR

The compound is characterized by a formulation that ensures effective action on the film-forming component. The presence of DNA fractions increases the viscosity of the solutions and increases the hydration of the mucous membranes with a consequent improvement in trophism for oral ulcers. The treatment indications are to delay and prevent oral ulcers and the formation of bacterial plaque; prevent irritation of the gums and oral cavity, even in wearers of prostheses and orthodontic implants accompanied by problems with dental support structures; after tooth extraction; before and after any dental surgery. The patients will be instructed to rinse the mouth and ulcers with the mouthwash twice a day after oral hygiene for 14 days

Device: Mouthwash Product

Placebo mouthwash

PLACEBO COMPARATOR

The placebo will be deprived by all components. The patients will be instructed to rinse the mouth and ulcers with the mouthwash twice a day after oral hygiene for 14 days

Device: Control

Interventions

Mouthwash Product DEVICE

DNA mouthwash

DNA mouthwash

Control DEVICE

Placebo mouthwash

Placebo mouthwash

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least one well-defined oral ulcer.
• Patients with no cognitive disorders able to provide mouthwash treatment independently

You may not qualify if:

• Proven intolerance or allergy to the product.
• Patients with a hematological deficit such as anemia, iron deficiency, vitamin B12 and/or folic acid
• No systemic diseases including ulcerative colitis, Crohn's disease, Behçet's syndrome with recurrent aphthous lesions; alcohol and tobacco consumption;
• No history of allergies;
• No previously treatment of oral ulcers with topical steroids, vitamins, antibiotics, antihistamines, oral retinoids, or immunomodulatory agents within three months prior to entering the study;
• No non-steroidal anti-inflammatory drugs or mouthwash administrations for the treatment of the ulcer within 72 hours before entering the study.
• Pregnants or breastfeeding patients.

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

University of Chieti- Department of Innovative Technology in Medicine and Dentistry

Chieti, Abruzzo, 66100, Italy

Location

MeSH Terms

Conditions

Stomatitis, Aphthous; Ulcer

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Antonio Scarano Antonio Scarano, MD DDS

  Department of Innovative Technology in Medicine and Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher, Department of Innovative Technologies in Medicine and Dentistry, University "G.d'Annunzio" of Chieti-Pescara

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 13, 2025
• Study Start: November 28, 2023
• Primary Completion: January 10, 2024
• Study Completion: February 24, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)