Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Patients

Mansoura University

Status: Completed

Conditions: Cancer; Trismus

Treatments: Other: screw tapered appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT06413628

A02011023RP

Details and patient eligibility

About

Aim: to compare different treatment modalities for radiation induced trismus for maxillofacial patients methods:45 participants (20 females and 25 males) with trismus and pain following head and neck cancer and underwent radiation therapy were enrolled in this study . patients were divided into three groups : group1 received threaded tapered screw appliance therapy, patients in group II received low-level laser therapy and patients in group III received low-level laser therapy in addition to threaded tapered screw appliance therapy.

Full description

All patients received treatment according to their group: For group I, received 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.

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.

Enrollment: 36 patients

Sex: All

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (a) Clinical diagnosis of trismus in head and neck cancer patients who received radiation therapy
• (b) unable to chew, swallow and muscles stiffness

Exclusion criteria

• (a) patients with Bell's palsy
• (b) patients still receiving radiation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

threaded tapered screw appliance therapy

Active Comparator group

Description:

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.

Treatment:

Other: screw tapered appliance

low-level laser therapy

Active Comparator group

Description:

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.

Treatment:

Other: screw tapered appliance

low level laser therapy combined with appliance

Active Comparator group

Description:

low-level laser therapy in addition to threaded tapered screw appliance therapy as mentioned previously in group I and group II

Treatment:

Other: screw tapered appliance