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临床试验/NCT05240703
NCT05240703已完成不适用

Efficacy of Stabilization Splint Treatment on Facial Pain - One-year Follow-up

University of Oulu0 个研究点目标入组 80 人开始时间: 2008年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
Subjective estimate on treatment outcome

研究概览

简要总结

The aim of this randomized controlled trial was to assess the efficacy of stabilization splint treatment on TMD-related facial pain and oral health-related quality of life during a one-year follow-up. Eighty TMD patients were randomly assigned to two groups: splint group (n=39) and control group (n=41). The patients in the splint group were treated with a stabilization splint and received counseling and instructions for masticatory muscle exercises. The controls received only counseling and instructions for masticatory muscles exercises.

The outcome variables were the intensity of facial pain (as measured with visual analogue scale, VAS), patients' subjective estimate of symptoms and treatment outcome, as well as Oral Heath Impact Profile (OHIP)-14. The differences in variables between the groups at each follow-up points (1 month, 3 months, 6 months and 1 year after baseline) were analyzed using regression models. Group status and presence of psychosocial symptoms were included as the explanatory factor and baseline VAS, gender, age, length of treatment and general health status as confounders.

详细描述

DESIGN OF THE STUDY The study sample consisted originally of 80 patients (18 men, 62 women) who were referred to the Oral and Maxillofacial Department in Oulu University Hospital, Oulu, Finland, for treatment of TMD-related facial pain. The patients were examined between March 2008 and August 2010. The inclusion criteria were the following: 1. clinically diagnosed TMD as defined by the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) (1), 2. minimum of 20 years of age and 3. lack of long-term illnesses (i.e. rheumatoid arthritis) that may affect TMJs or the masticatory muscles.

Using computer generated random numbers, the patients were randomly assigned to two groups: splint group and control group. Patients in the control group (n=41) were given counseling and guidance for masticatory muscle exercises. In addition to these, the patients in the splint group (n=39) were also treated with a stabilization splint.

DATA COLLECTION The patients had four follow-ups: at about 1 month, 3 months, 6 months and one year after the baseline evaluation. The same dentist specialized in stomatognathic physiology (KS) conducted all of the follow-up examinations, being unaware of the group status of the patients. At baseline the psychosocial screening (depression symptoms, non-specific physical symptoms, pain-related disability) was performed using RDC/TMD Axis II instruments. At baseline and at all the follow-ups the intensity of the facial pain was assessed using Visual Analogue Scale (VAS). The patients' subjective estimates of the effects of the treatment were evaluated with a questionnaire, using a scale from 1 to 4 (1= Very good effect, 2= Treatment has helped to some extent, 3= No difference / Cannot tell and 4= Symptoms worsened). The patients' general health status was also inquired by a questionnaire (on a scale of 1-5, 1=excellent, 2=very good, 3=good, 4=moderate, 5=poor). The patients filled in the Oral Health Impact Profile-14 (OHIP-14) questionnaire before treatment and at 3 months, 6 months and 1 year.

TREATMENT PROCEDURES The stabilization splints were made of heat-cured acrylic by the same dental technician. The occlusion of the splint was defined in the centric relation occlusion using wax (Astynax, Associated Dental Products Ltd, UK). The patients were instructed to use the splint every night during the course of the study.

All the patients in both groups were instructed to perform a standardized program for masticatory muscle exercises as described by Carlsson and Magnusson (1992). At the beginning of the training program, active mouth openings, laterotrusion and protrusion movements were performed. The mandible was held in the maximal positions for a few seconds on each movement. Thereafter, these movements were made towards resistance (using the patient's own fingers). After jaw exercises, the patients were suggested to open the jaw wide, stretching it with fingers a few times for 10 to 20 seconds. These movements were repeated 7 to 10 times per training session, and the sessions were performed 2-3 times per day. The patients received written instructions, and the movements were also demonstrated by the dentist before the treatment, and reprised if necessary. The instructions for masticatory muscle exercises were given by the same dentist (KS) at the first visit. At every examination the patients were reminded to use the splint and/or to perform the exercises at a regular basis.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The same dentist examiner conducted all of the follow-up examinations, being unaware of the group status of the patients.

入排标准

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

入选标准

  • 未提供

排除标准

  • Presence of any chronic diseases, such as rheumatoid arthritis, that may affect the TMJ or the masticatory muscles

结局指标

主要结局

Subjective estimate on treatment outcome

时间窗: 1 year follow-up

The patients' subjective estimates of the effects of the treatment were evaluated with a questionnaire, using a scale from 1 to 4 (1= Very good effect, 2= Treatment has helped to some extent, 3= No difference / Cannot tell and 4= Symptoms worsened).

Subjective estimate on symptom severity

时间窗: 1 year follow-up

The subjective assessment of the severity of TMD symptoms after treatment was assessed by means of a scale on 1 to 5 (1= 'no symptoms'/ 'symptoms not significant', 2 = 'mild symptoms', 3 = 'moderate symptoms', 4 = 'severe symptoms', 5 = 'intolerable symptoms')

Change of Oral health related quality of life (OHRQoL)

时间窗: from baseline to 1-year follow-up

Change of Oral health related quality of life was assessed using Oral Health Impact Profile (OHIP-14, sum score from 0 to 56, the higher value indicating poorer OHRQoL)

Change in facial pain intensity

时间窗: from baseline to 1-year follow-up

The change of the intensity of the facial pain, assessed using Visual Analogue Scale (VAS) on a 0 (no pain) to 10 (pain as bad as could be) rating

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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