## Protocol Section
### Identification Module
**NCT ID:** NCT06413628

**Brief Title:** Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Patients

**Official Title:** Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Cases

#### Organization Study ID Info
**ID:** A02011023RP
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2023-12-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-08-13

**Type:** ACTUAL

#### Start Date
**Date:** 2022-04-11

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-19
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Trismus

- Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** The randomization and assignment of patients to treatment groups was carried out by dental experts who were not informed about the treatment groups.

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Other: screw tapered appliance

**Label:** threaded tapered screw appliance therapy

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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.

**Intervention Names:**

- Other: screw tapered appliance

**Label:** low-level laser therapy

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

- Other: screw tapered appliance

**Label:** low level laser therapy combined with appliance

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- low level laser therapy combined with appliance

- low-level laser therapy

- threaded tapered screw appliance therapy

**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 printerwas loaded with material of 3D-printed denture base. The appliance was printed.

**Name:** screw tapered appliance

**Other Names:**

- low level laser therapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

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

**Time Frame:** six months

**Description:** 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)

**Measure:** Satisfaction assessed by the (VAS)visual analogue scale of pain

**Time Frame:** six months

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 70 Years

**Minimum Age:** 55 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mansoura

**Country:** Egypt

**Facility:** Marwa Aboelez

#### Overall Officials

**Official 1:**

**Affiliation:** Mansoura University

**Name:** marwa aboelez, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013035

- Term: Spasm

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M17065

- Name: Trismus

- Relevance: HIGH

- As Found: Trismus

- ID: M12077

- Name: Muscle Cramp

- Relevance: LOW

- As Found: Unknown

- ID: M15837

- Name: Spasm

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014313

- Term: Trismus

### Misc Info Module

- Version Holder: 2024-05-31
