Comparison of the Effects of Oral Ulceration Healing in Patients Wearing a Removable Denture (MUCOSA HEALING)

Medical University of Silesia

Status: Completed

Conditions: Oral Mucosa; Ulcer

Treatments: Drug: Chlorhexidine Gluconate; Drug: Choline Salicylate 8.7 % Oral Gel; Other: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06531720

SUM MUCOSA HEALING

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

27 participants in 3 patient groups

0,2% CHX topical use

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine Gluconate

8,7% CHS topical use

Experimental group

Description:

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.

Treatment:

Drug: Choline Salicylate 8.7 % Oral Gel

Control

Experimental group

Description:

Patients were not using any topical medications.

Treatment:

Other: control group