TrismusNCT06413628
Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Patients
A study testing screw tapered appliance in people with Trismus and Cancer, run by Mansoura University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 55 to 70 years
- What is being tested?
- screw tapered appliance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2022to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (a) Clinical diagnosis of trismus in head and neck cancer patients who received radiation therapy
- (b) unable to chew, swallow and muscles stiffness
Who cannot join
- (a) patients with Bell's palsy
- (b) patients still receiving radiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Cases
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.
Read the 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.
- Being tested
- screw tapered appliance
- Medical subject headings
- Trismus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screw tapered applianceOther
Also called low level laser 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 printerwas loaded with material of 3D-printed denture base. The appliance was printed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: screw tapered appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start11 Apr 2022
- Primary completion13 Aug 2022
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TrismusStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- marwa aboelez, PhD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413628
- Sponsor's protocol ID
- A02011023RP
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16280237Aboelez 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.
PubMed 40038715
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Different Treatment Modalities on Radiation Induced Trismus for Maxillofacial Cases
- ClinicalTrials.gov ID
- NCT06413628
- Acronym / sponsor ID
- A02011023RP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 13 Aug 2022 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| threaded tapered screw appliance therapy | Active comparator | Other: screw tapered applianceThe 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. |
| low-level laser therapy | Active comparator | Other: screw tapered applianceThe 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. |
| low level laser therapy combined with appliance | Active comparator | Other: screw tapered appliancelow-level laser therapy in addition to threaded tapered screw appliance therapy as mentioned previously in group I and group II |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (a) Clinical diagnosis of trismus in head and neck cancer patients who received radiation therapy
- (b) unable to chew, swallow and muscles stiffness
Key exclusion criteria (2 listed)
- (a) patients with Bell's palsy
- (b) patients still receiving radiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screw tapered applianceAlso: low level laser therapyThe 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 | low level laser therapy combined with appliance, low-level laser therapy, threaded tapered screw appliance therapy |
Primary outcome
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Results publication: PubMed 16280237Dijkstra 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.
- Derived from this study: PubMed 40038715Aboelez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marwa aboelez, PhD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screw tapered appliance in people with Trismus and Cancer, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06413628, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.