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Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05548894
Collaborator
(none)
42
Enrollment
1
Location
3
Arms
12.1
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Stabilization splint therapy and Low-level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low-level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low- level laser therapy, group II received low - level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention.

Condition or Disease Intervention/Treatment Phase
  • Device: stabilization splint
  • Device: laser therapy
  • Device: stabilization splint and laser therapy
 N/A

Detailed Description

Objectives: Stabilization splint therapy and low- level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low- level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction.

Patients and methods: 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low-level laser therapy, group II received low-level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention. Time of being normal was also evaluated.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel clinical trialParallel clinical trial
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Comparison Between the Efficacy of Stabilization Splint and Low Level Laser Therapy for Treatment of Patients With Chronic Closed Lock of the Non-reducible Temporo-mandibular Joint Disc. A Parallel Randomized Clinical Trial.
Actual Study Start Date :
Mar 3, 2021
Actual Primary Completion Date :
Feb 6, 2022
Actual Study Completion Date :
Mar 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: stabilization splint

acrylic splint in the maxillary arch with flat surface

Device: stabilization splint
upper acrylic splint rest on the maxillary teeth and had flat surface
Other Names:
  • upper acrylic full arch splint

    		•
    Active Comparator: laser therapy

    laser beam directed to the affected part cause activation of blood circulation

    Device: laser therapy
    The laser apparatus had a hand piece on which either a specially designed optic prism was attached to transfer laser energy to the tip of the prism
    Other Names:
  • Low-level laser therapy

    		•
    Active Comparator: stabilization splint and laser therapy

    using both laser therapy and stabilization splint for more improvement

    Device: stabilization splint and laser therapy
    the stabilization splint used in combination of treatment with laser therapy
    Other Names:
  • splint combined with low level laser therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. evaluation of mouth opening [6 months]

      improvement in mouth opening or not

    2. Masticatory muscles palpation [6 months]

      the masticatory muscles were palpated bilaterally with firm and constant pressure of one kg lasted two seconds to define painful areas

    3. temporomandibular joint palpation [6 months]

      joint pain was achieved by first palpating the temporomandibular joint lateral pole by placing the index finger with firm and constant pressure of half kg lasted two seconds over the condyle in front of the tragus

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of chronic closed lock patients

    • Must not be able to open their mouth

    Exclusion Criteria:

    • neurologic diseases

    • TMJ pathologic lesions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mansoura university Mansoura Egypt

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    • Principal Investigator: Noha Elshahid, lecturer at mansoura university prosthodontic department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mansoura University
    ClinicalTrials.gov Identifier:
    NCT05548894
    Other Study ID Numbers:
    • A34080622
    First Posted:
    Sep 22, 2022
    Last Update Posted:
    Sep 27, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 27, 2022