Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Patients
NCT ID: NCT06413628
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2022-04-11
2023-12-10
Brief Summary
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Detailed Description
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For group II received low-level laser therapy, the laser type was of diode laser.The laser apparatus consisted of a hand piece with two attachments: either a plastic tip was attached to the same hand piece to transfer laser energy intro-orally when it was used to irradiate the lateral pterygoid muscle, or a specially designed optic prism was attached to the tip of the prism for extraoral application on extra oral muscles. All patients in this group received low level laser therapy twice times a week for 6 weeks totaling 12 sessions. In each session, the laser beam was applied in a three phases treatment protocol as follows: (a) The insertion of the lateral pterygoid muscle into the condylar neck and disc was treated in the first phase by applying a laser beam 1 cm anterior to the condyle below the zygomatic arch. (b) Tender spots in the masseter and temporalis muscles that were found during the initial assessment were exposed to radiation during the second phase. (c) The lateral pterygoid muscle origin was exposed to radiation in the third phase, which was performed with the mouth slightly open and intro-orally posterior to the final molar. During each phase, the laser was operated for two minutes per area at a wavelength of 810 nm and a peak output of 500 mW. It was applied continuously, a little distance away from the tissues. The laser probe was positioned perpendicular to the target area. Prior to usage, the laser was calibrated. Protective glasses were worn by the clinician and the patients. For group III, received low-level laser therapy in addition to threaded tapered screw appliance therapy as mentioned previously in group I and group II. Concurrent with the initial low level laser therapy session, screw tapered appliance was used for the first time.
Throughout the trial, no medication was administered to any of the groups. The patients were not allowed to use any painkillers or analgesics.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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threaded tapered screw appliance therapy
The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format. The virtual design of was approved. The printer was loaded with material of 3D-printed denture base. The appliance was printed.
screw tapered appliance
The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format. The virtual design of was approved. The printerwas loaded with material of 3D-printed denture base. The appliance was printed.
low-level laser therapy
The laser apparatus consisted of a handpiece with two attachments: either a plastic tip was attached to the same handpiece to transfer laser energy intra-orally when it was used to irradiate the lateral pterygoid muscle, or a specially designed optic prism was attached to the tip of the prism for extraoral application on extraoral muscles.
screw tapered appliance
The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format. The virtual design of was approved. The printerwas loaded with material of 3D-printed denture base. The appliance was printed.
low level laser therapy combined with appliance
low-level laser therapy in addition to threaded tapered screw appliance therapy as mentioned previously in group I and group II
screw tapered appliance
The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format. The virtual design of was approved. The printerwas loaded with material of 3D-printed denture base. The appliance was printed.
Interventions
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screw tapered appliance
The appliance was digitally designed by solid works programs for 3rd CAD design software to obtain the STL file format. The virtual design of was approved. The printerwas loaded with material of 3D-printed denture base. The appliance was printed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (b) unable to chew, swallow and muscles stiffness
Exclusion Criteria
* (b) patients still receiving radiation.
55 Years
70 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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marwa aboelez, PhD
Role: STUDY_DIRECTOR
Mansoura University
Locations
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Marwa Aboelez
Al Mansurah, , Egypt
Countries
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References
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Dijkstra PU, Huisman PM, Roodenburg JL. Criteria for trismus in head and neck oncology. Int J Oral Maxillofac Surg. 2006 Apr;35(4):337-42. doi: 10.1016/j.ijom.2005.08.001. Epub 2005 Nov 8.
Aboelez MA, Ibrahim AM, ElSawy MA, Sayed El-Khamisy NE. Efficiency of different treatment modalities on radiation induced trismus for maxillofacial cases: a parallel randomized clinical trial. BMC Oral Health. 2025 Mar 4;25(1):332. doi: 10.1186/s12903-025-05600-7.
Other Identifiers
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A02011023RP
Identifier Type: -
Identifier Source: org_study_id
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