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Completed

NCT Number: NCT06531720

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of TMD Silesian Medical University

Zabrze, 41-800, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate

Drug

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

Choline Salicylate 8.7 % Oral Gel

Drug

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

Control Group

Other

no medication has been prescribed

Primary outcomes

  1. Comparing the effectiveness of oral mucosa lesion healing of different preparations

    Time frame: From 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.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

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

Acronym: MUCOSA HEALING

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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