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临床试验/NCT06531720
NCT06531720已完成不适用

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

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Comparing the effectiveness of oral mucosa lesion healing of different preparations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Chlorhexidine Gluconate (Drug)

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.

干预措施: Choline Salicylate 8.7 % Oral Gel (Drug)

Control

Experimental

Patients were not using any topical medications.

干预措施: control group (Other)

结局指标

主要结局

Comparing the effectiveness of oral mucosa lesion healing of different preparations

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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