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Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction

Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03576079
Enrollment
30
Registered
2018-07-03
Start date
2015-09-01
Completion date
2018-06-01
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

Keywords

laser therapy, anterior re-positioning splint

Brief summary

comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.

Detailed description

to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation period.

Interventions

DEVICELaser therapy

epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.

DEVICEanterior re-positioning splint

hard acrylic anterior re-positioning splint

DEVICEinactive Laser therapy

sham Laser, with inactive beam

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients having TMD in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the MRI. 2. Good general health: The patient must be medically free from any systemic disease or health problems. 3. Adult patients 18 years old and above. 4. No previous orthodontic treatment. 5. No previous TMJ treatment or surgery.

Exclusion criteria

1. Patients with multiple missing posterior teeth. 2. Muscle pain due to systemic disease. 3. Dental related pain. 4. Congenital abnormality, neoplasia or acute trauma. 5. Previous TMJ treatment or surgery. 6. Any medical condition that prohibits MRI acquisition.

Design outcomes

Primary

MeasureTime frameDescription
Level of temporomandibular joint pain: assessed by using subjective visual analogue scale3 monthscurrent level of temporomandibular joint pain assessed by using subjective visual analogue scale from 1 to 10 according to the research diagnostic criteria of temporomandibular disorders diagnostic sheets, zero indicates no pain, while 10 indicates the worst pain

Secondary

MeasureTime frameDescription
click: joint sound3 monthsjoint sound., it is a binary measurement assessed by hand palpation
limitation of mandibular movements3 monthsmouth opening, measured between the incisal edges of upper and lower incisors using a digital caliper, right and left mandibular movements, measured from upper dental midline to lower dental midline using a digital caliper.
disc recapture3 monthschange in articular disc morphology and configuration using two dimensional measurements on a DICOM viewer software including both linear and angular measurements in relation to cartesian coordinates X and Y

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026