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

Comparison of the Effects of Mucosa Tissue Healing in Patients Wearing a Removable Prosthetic Restoration - Pilot Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531720
Acronym
MUCOSA HEALING
Enrollment
27
Registered
2024-08-01
Start date
2023-01-01
Completion date
2023-12-31
Last updated
2024-08-01

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

Conditions

Oral Mucosa; Ulcer

Keywords

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

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.

Detailed description

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. These medications, with different functional properties, are recommended for patients who develop oral mucosa lesions during adaptation to new removable prostheses. The evaluation of the efficacy of these agents was based on a comparison of the area of OML before and after the treatment. The study was designed to evaluate healing after the application of a topical medication containing 0.2% chlorhexidine digluconate and 8,7% choline salicylate as an active ingredient. Patients were asked to use topical medication 3 times a day, applying the size of a pea on the oral mucosa lesion. Participants in groups CHX and CHS were instructed not to eat or drink for 1 hour following the application of medication because of its functional and antibacterial properties. Patients were asked to wear new dentures between control visits, even when they felt discomfort while using them. Patients in the control group were not using any topical medication. According to randomization patients suffering from oral mucosa lesion (OML) were divided into three groups. Using a transparent millimeter grid superimposed on the OML, the Wound Surface Area (WSA) was measured in mm\^2. A very precise measurement of the WSA was possible thanks to the use of a millimeter scale on the digital photo image. Every, even partially filled square was included in the area of the OML. Graphical analysis using Photo for Windows Software consisted of adding all the squares within which the OML was observed. All the intraoral images of OML have been taken in reproducible conditions (ambient light, lens and camera settings, distance 5 cm). This measurements were carried out during all check-up visits on day 0, 1, 4, 7 and 14.

Interventions

DRUGChlorhexidine Gluconate

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

DRUGCholine Salicylate 8.7 % Oral Gel

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

OTHERcontrol group

no medication has been prescribed

Sponsors

Medical University of Silesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

A randomized, double-blind study was conducted, based on the CONSORT study protocol for randomized clinical trials.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Comparing the effectiveness of oral mucosa lesion healing of different preparationsFrom baseline assessment up to 2 weeks.Using a transparent millimeter grid superimposed on the oral mucosa lesion, the Wound Surface Area (WSA) was measured in mm\^2.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026