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Completed

NCT Number: NCT06413628

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

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.

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Key information

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Aboelez

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

screw tapered appliance

Other

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 names: low level laser therapy

Primary outcomes

  1. patient satisfaction(Quality of life) assessed by the Gothenburg Trismus Questionnaire (GTQ) which is a trismus-specific self-administered questionnaire

    Time frame: six months

    was assessed using Gothenburg trismus questionnaire witha scale ranging between 0-100, where a higher score indicates greater perceived dysfunction due to trismus. It contains three main domains 1-Jaw related problems 2- Eating limitations 3-Muscular tension

  2. Satisfaction assessed by the (VAS)visual analogue scale of pain

    Time frame: six months

    the patients filled out a self-assessment 0 to 10 visual analogue scale (VAS) for Pain (where 0 equals no pain and 10 is the most severe pain)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 14, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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