Comparison of the Effects of Oral Ulceration Healing in Patients Wearing a Removable Denture

NCT06531720 | Completed

• 1 other identifier: SUM MUCOSA HEALING
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was comparing the effectiveness of oral mucosa healing properties of different preparations: CHX=0,2% chorhexidine digluconate, CHS=8,7% choline salicylate, CON=control group, in patients with delivered removable dentures, during the adaptation period.

Conditions

Oral Mucosa; Ulcer

Keywords

prosthetic materials; functional properties; antibacterial properties; chlorhexidine; choline salicylate

Outcome Measures

Primary Outcomes (1)

• Comparing the effectiveness of oral mucosa lesion healing of different preparations

  Using a transparent millimeter grid superimposed on the oral mucosa lesion, the Wound Surface Area (WSA) was measured in mm\^2.

  From baseline assessment up to 2 weeks.

Study Arms (3)

0,2% CHX topical use

EXPERIMENTAL

Patients were asked to use topical medication containing 0,2% chlorhexidine 3 times a day, applying the size of a pea on the oral mucosa lesion until full wound healing or up to 14 days.

Drug: Chlorhexidine Gluconate

8,7% CHS topical use

EXPERIMENTAL

Patients were asked to use topical medication containing 8,7% choline salicylate 3 times a day, applying the size of a pea on the oral mucosa lesion until full wound healing or up to 14 days.

Drug: Choline Salicylate 8.7 % Oral Gel

Control

EXPERIMENTAL

Patients were not using any topical medications.

Other: control group

Interventions

Chlorhexidine Gluconate DRUG

topical preparation applied on oral mucosa lesion containing 0,2% CHX

0,2% CHX topical use

Choline Salicylate 8.7 % Oral Gel DRUG

topical preparation applied on oral mucosa lesion containing, ethanol-based

8,7% CHS topical use

control group OTHER

no medication has been prescribed

Control

Eligibility Criteria

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

You may qualify if:

• oral mucosa lesion OML as a result of new denture adaptation
• partial dentures II and III
• prostheses delivered for the during the period of the study patient
• patient consent

You may not qualify if:

• systemic conditions affecting the wound healing: diabetes
• prosthetic stomatitis according to Newton's classification
• parafunctional habits, bruxism
• autoimmune diseases

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Department of TMD Silesian Medical University

Zabrze, 41-800, Poland

Location

MeSH Terms

Conditions

Oral Ulcer

Interventions

chlorhexidine gluconate; choline salicylate; Gels; Control Groups

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A randomized, double-blind study was conducted, based on the CONSORT study protocol for randomized clinical trials.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: According to randomization patients suffering from oral mucosa lesion (OML) were divided into three groups: * Group I: oral mucosa lesions treated with 0,2% CHX topical use, * Group II: oral mucosa lesions treated with 8,7% CHS topical use and * Group III: oral mucosa lesions as control group-CON with no specific OML treatment. The efficacy of oral topical medications in aiding regeneration and healing of oral soft mucosa, caused by the use of removable prosthetic restorations was analyzed. The evaluation of the efficacy of these agents was based on a comparison of the area of OML before and after the treatment. Patients in the control group were not using any topical medication.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 1, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

PL (1)