Orthognathic SurgeryNCT05717322
TENS and Orthognathic Surgery
A study testing TENS in people with Orthognathic Surgery, run by Fayoum University at 1 site in Egypt.
Trial summary
All patients with skeletal deformity will undergo orthognathic surgery after orthodontic treatment. After surgery TENS electrodes( rubber electrodes with the same size 5.3×4.8 cm) will be Placed bilaterally on ant temporalis and bilaterally on superficial masseter muscle…Time : 30 min /3 times per week/ 6 weeks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- TENS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2023to 30 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Class II facial deformity
- absence of temporomandibular joint pain and preoperative opening mouth limitation
- normal cranial form
- presence of dentition
- Fit to GA
Who cannot join
- temporomandibular joint pain and preoperative opening mouth limitation;
- craniofacial anomalies and abnormal cranial form
- absence of facial trauma, mandibular condylar fracture
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fayoum University
Al Fayyum
shaimaa refahee, phd, 01227407987, smr11@fayoum.edu.eg
About this study
Official title: The Effect of Transcutaneous Stimulation (TENS) on the Recovery of Muscle Function After Orthognathic Surgery
All patients with skeletal deformity will undergo orthognathic surgery after orthodontic treatment. After surgery TENS electrodes( rubber electrodes with the same size 5.3×4.8 cm) will be Placed bilaterally on ant temporalis and bilaterally on superficial masseter muscle…Time : 30 min /3 times per week/ 6 weeks
- Conditions
- Orthognathic Surgery
- Being tested
- TENS, sham TENS
- Keywords
- orthognathic, TENS, EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSBehavioural
apply TENS after orthognathic surgery
sham TENSBehavioural
apply non active TENS after orthognathic surgery
| Study group | Role | What they receive |
|---|---|---|
| TENS arm | Experimental | Not described Receives: Behavioral: TENS |
| non TENS arm | Active comparator | Not described Receives: Behavioral: sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum mouth opening
will be measured by
caliber between the incisal edges of upper and lower centrals
Measured: 6 months
Secondary outcomes (2)
visual analogue scale
will be measured by VAS scale at the same time points of mouth opening(0_10) 0 represent no pain,10represent high pain
Measured: 6months
muscle activity
measured by EMG at the same time points
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start22 Jan 2023
- Primary completion22 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717322
- Sponsor's protocol ID
- EC2227
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Stimulation (TENS) on the Recovery of Muscle Function After Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT05717322
- Acronym / sponsor ID
- EC2227
- Conditions
- Orthognathic Surgery
- Keywords
- orthognathic, TENS, EMG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 22 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 8 Feb 2023 (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.
All patients with skeletal deformity will undergo orthognathic surgery after orthodontic treatment. After surgery TENS electrodes( rubber electrodes with the same size 5.3×4.8 cm) will be Placed bilaterally on ant temporalis and bilaterally on superficial masseter muscle…Time : 30 min /3 times per week/ 6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS arm | Experimental | Behavioral: TENS |
| non TENS arm | Active comparator | Behavioral: sham TENS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Class II facial deformity
- absence of temporomandibular joint pain and preoperative opening mouth limitation
- normal cranial form
- presence of dentition
- Fit to GA
Key exclusion criteria (3 listed)
- temporomandibular joint pain and preoperative opening mouth limitation;
- craniofacial anomalies and abnormal cranial form
- absence of facial trauma, mandibular condylar fracture
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 |
|---|---|---|
| TENSapply TENS after orthognathic surgery | Behavioural | TENS arm |
| sham TENSapply non active TENS after orthognathic surgery | Behavioural | non TENS arm |
Primary outcome
maximum mouth opening
Time frame: 6 months
will be measured by caliber between the incisal edges of upper and lower centrals
2 secondary outcomes
visual analogue scale
Time frame: 6months
muscle activity
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Orthognathic Surgery, run by Fayoum 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa Refahee (01227407987, smr11@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum mouth opening (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.