Photobiomodulation in Temporomandibular Disorder
2018年3月28日 更新者：Lara Jansiski Motta、University of Nove de Julho
Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.
The general purpose of this project is to evaluate the cost-effectiveness of LIL treatment and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with TMD.
調査の概要
詳細な説明
Temporomandibular disorder (TMD) affects a significant portion of the population.
Epidemiological data show that the signs and symptoms of TMD start to become apparent from six years of age, and in adolescence these signs and symptoms are similar to those of adults.
The painful conditions of TMD can affect the quality of life of young patients, compromising the daily activities of these individuals.
The present project aims (1) to estimate the direct costs of treatment of muscle pain in patients with TMD with low-intensity laser and with occlusal plate and a placebo group; (2) to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD; (3) to analyze the cost-effectiveness of the two proposed treatments for pain; and (4) to describe and compare the results of analyses of treatments for pain in patients with TMD.
The study will be conducted at the Odontological Clinic of Universidade Nove de Julho.
It is a prospective trial of clinical and economic analysis.
It will include 30 patients aged between 15 and 25 years with TMD, randomly assigned to a treatment group: G1 (low-power laser), G2 (occlusal plate) and G3 (placebo).
The analysis will be based on the direct costs of each treatment during the 12-month period, estimating the cost of each treatment.
The outcome for the analysis of the effectiveness will be the pain, measured periodically by means of the clinical examination of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
The cost-effectiveness ratio will be calculated using, as endpoints, pain and the calculation of the ratio between the difference in costs between the groups studied.
The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D.
研究の種類
介入
入学 (予想される)
45
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Sao Paulo
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São Paulo、Sao Paulo、ブラジル、18130 430
- 募集
- Lara Motta
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コンタクト：
- Lara Motta, PhD
- 電話番号：5511998829511
- メール：larajmotta@terra.com.br
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
15年～25年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- people between 15 and 25 years
- diagnosis of TMD in group I
Exclusion Criteria:
- Individuals with dental-facial anomalies
- orthodontic or orthopedic treatment
- Individuals who were taking muscle relaxants or anti-inflammatory medications
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Low-intensity laser
Twelve laser applications will be applied as initial treatment, with 2 sessions per week.
A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point.
The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2, in accordance with the protocol suggested by Venezian et al. (2010) and Carvalho et al. (2010).
The laser will be applied to 3 points of the masseter muscle (upper, middle, and lower bundles) and 1 point in the anterior temporalis on each side of the face
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Laser applications will be applied as initial treatment, with 2 sessions per week.
A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point.
The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
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アクティブコンパレータ：Occlusal Plate
The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998). Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide. Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment |
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998). Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide. Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment |
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プラセボコンパレーター：Placebo
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
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For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain
時間枠：12 months after treatment
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Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders
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12 months after treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cost-effectviness
時間枠：12 months after treatment
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This phase of the study will consist in the quantification of resources, i.e. determining the frequency of use of resources and materials during the treatment.
The units used to quantify the direct costs consumed are physical units such as consultation time, number of sessions, equipment used, and materials consumed.
These data will be collected using a specific form.
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12 months after treatment
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協力者と研究者
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出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年10月10日
一次修了 (実際)
2018年1月21日
研究の完了 (予想される)
2018年10月10日
試験登録日
最初に提出
2017年3月9日
QC基準を満たした最初の提出物
2017年3月23日
最初の投稿 (実際)
2017年3月30日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月30日
QC基準を満たした最後の更新が送信されました
2018年3月28日
最終確認日
2018年3月1日
詳しくは
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