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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06413628
• Other study ID #: A02011023RP
• Status: Completed
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: December 10, 2023

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 10, 2023
• Est. primary completion date: August 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Trismus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Egypt	Marwa Aboelez	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction(Quality of life) assessed by the Gothenburg Trismus Questionnaire (GTQ) which is a trismus-specific self-administered questionnaire	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	six months
Primary	Satisfaction assessed by the (VAS)visual analogue scale of pain	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)	six months