An interventional study of Isometric mandibular exercises and Isotonic mandibular exercises in Temporomandibular Disorders, sponsored by Universidad Nacional Andres Bello. Completed. Open to female participants aged 18 Years to 26 Years. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by Universidad Nacional Andres Bello · Not applicable, Interventional, and Treatment
The effectiveness of mandibular exercises as a treatment of muscular Orofacial Pain is yet unknown. This study hypothesized that training exercises can be an effective therapy improving pain perception.
Temporomandibular disorders (TMDs) represent heterogeneous musculoskeletal disorders, where most common presentation is mandibular muscle pain, which is also more common among female than men. Many interventions have been proposed for this pain control, regarding drugs, oral splints, relaxing exercises and self awareness but little is known about mandibular active contraction exercises. The aim of this study is to evaluate the effects of mandibular exercises in pain perception and sensitivity in women. A double blind randomized clinical trial will be conducted among fertile university student women with Oral Contraceptives (OC) use -to control hormonal influences-, with report of facial pain and myofascial pain diagnosis (RDC/TMD). They will be assessed in Visual analogue scale (VAS), sleep quality, Pressure Pain Threshold (PPT) and pressure pain tolerance (PPTol), and then allocated in one of the three interventions for 21 days: isometric mandibular active exercises over silicone bars; video-guided isotonic mandibular contractions over cloth pegs or counseling about disorders nature as passive comparison. After 21 days, VAS, PPT and PPTol in bilateral temporalis and masseter muscles will be assessed for a second time,) and compared with initial pain status.
Data will be entered by single blind operator, and will be open for quality auditing. Site monitoring will be performed by the University clinical entities.
Data checks will be also performed as planned. Descriptive and analytical statistics will be performed to address the primary and secondary objectives.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's enrollment of 45 is close to the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Universidad Nacional Andres Bello is the lead sponsor of 23 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group of participants which perform Isometric mandibular exercises, once a day, for 21 days
Other: Isometric mandibular exercises
Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days
Other: Isotonic mandibular exercises
Group of participants which receive education brochure and no further interventions.
Behavioral: Counseling group
daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars
daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors
subjects included in this group get an education brochure about the disorder and receive no further interventions
Change in the weekly mean subjective pain index after 21 days of treatment
Weekly mean subjective pain computed as the arithmetic mean of daily pain subjective values (visual analog scale - VAS) in Visit 1and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") for the different muscular sites tested.
Time frame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment
Weekly mean pressure pain threshold is computed as the arithmetic mean of daily pressure pain threshold values for muscular sites in Visit 1and prior to each study visit. Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Time frame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment
Weekly mean pressure pain tolerance is computed as the arithmetic mean of daily pressure pain tolerance values for muscular sites in Visit 1and prior to each study visit. Plot is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied per anatomical muscle site.
Time frame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Change in pressure pain threshold at temporalis muscle after 1 week of treatment
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Change in pressure pain threshold at temporalis muscle after 2 weeks of treatment
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 14) ( 7 days in between)
Change in pressure pain threshold at temporalis muscle after 3 weeks of treatment
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 7 days in between)
Change in pressure pain threshold at masseter muscle after 1 week of treatment
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Change in pressure pain threshold at masseter muscle after 2 weeks of treatment
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Change in pressure pain threshold at masseter muscle after 3 weeks of treatment
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of t masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Change in pressure pain tolerance at temporalis muscle after 1 week of treatment
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Change in pressure pain tolerance at temporalis muscle after 2 weeks of treatment
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Change in pressure pain tolerance at temporalis muscle after 3 weeks of treatment
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Change in pressure pain tolerance at masseter muscle after 1 week of treatment
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Change in pressure pain tolerance at masseter muscle after 2 weeks of treatment
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Change in pressure pain tolerance at masseter muscle after 3 weeks of treatment
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
Time frame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Change in the Pittsburgh Sleep Quality Index (PSQI) global score after 21 days of treatment
The PSQI has 19 items grouped into 7 component scores, each weighted equally on a 0-3 scale. The 7 component scores are summed to obtain a global score, which has a range of 0-21.
Time frame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
No study locations are listed for this record.
Plan to share: No — no plan
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Universidad Nacional Andres Bello