Photobiomodulation in Temporomandibular Disorder
28 mars 2018 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
45
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Sao Paulo
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São Paulo, Sao Paulo, Brasilien, 18130 430
- Rekrytering
- Lara Motta
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Kontakt:
- Lara Motta, PhD
- Telefonnummer: 5511998829511
- E-post: larajmotta@terra.com.br
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år till 25 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Aktiv komparator: 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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Placebo-jämförare: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cost-effectviness
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 oktober 2017
Primärt slutförande (Faktisk)
21 januari 2018
Avslutad studie (Förväntat)
10 oktober 2018
Studieregistreringsdatum
Först inskickad
9 mars 2017
Först inskickad som uppfyllde QC-kriterierna
23 mars 2017
Första postat (Faktisk)
30 mars 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 mars 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 mars 2018
Senast verifierad
1 mars 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Ledsjukdomar
- Muskuloskeletala sjukdomar
- Muskelsjukdomar
- Stomatogena sjukdomar
- Käksjukdomar
- Kraniomandibulära sjukdomar
- Mandibular sjukdomar
- Myofasciala smärtsyndrom
- Temporomandibulära ledstörningar
- Temporomandibular Joint Dysfunction Syndrome
- Anti-infektionsmedel
- Dermatologiska medel
- Antifungala medel
- Keratolytiska medel
- Salicylsyra
Andra studie-ID-nummer
- CEPhotobio01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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