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

NCT06413628 | Completed

• 1 other identifier: A02011023RP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trismus; Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

threaded tapered screw appliance therapy

ACTIVE COMPARATOR

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.

Other: screw tapered appliance

low-level laser therapy

ACTIVE COMPARATOR

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.

Other: screw tapered appliance

low level laser therapy combined with appliance

ACTIVE COMPARATOR

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

Other: screw tapered appliance

Interventions

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.

Also known as: low level laser therapy

low level laser therapy combined with appliance; low-level laser therapy; threaded tapered screw appliance therapy

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Marwa Aboelez

Al Mansurah, Egypt

Location

Related Publications (2)

• 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.

  PMID: 16280237 RESULT

• 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.

  PMID: 40038715 DERIVED

MeSH Terms

Conditions

Trismus; Neoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• marwa aboelez, PhD

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The randomization and assignment of patients to treatment groups was carried out by dental experts who were not informed about the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: group I 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.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: May 14, 2024
• Study Start: April 11, 2022
• Primary Completion: August 13, 2022
• Study Completion: December 10, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-03

Locations

EG (1)