Postoperative Facial Nerve DysfunctionNCT07771933
Comparison of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following TMJ Surgery
A study testing GRR Laser Photobiomodulation System and SiroLaser Advance Plus in people with Postoperative Facial Nerve Dysfunction, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial compared two photobiomodulation systems for the management of postoperative facial nerve dysfunction following temporomandibular joint surgery. Patients who developed clinically detectable facial nerve dysfunction after open temporomandibular joint surgery were randomly assigned to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Facial Nerve Dysfunction
- What is being tested?
- GRR Laser Photobiomodulation System and SiroLaser Advance Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2022to 22 Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who underwent open temporomandibular joint surgery.
- Presence of clinically confirmed postoperative facial nerve dysfunction.
- Willingness to comply with the follow-up protocol and attend scheduled follow-up visits.
- Provision of written informed consent.
Who cannot join
- Pre-existing facial nerve paralysis or facial nerve dysfunction before surgery.
- History of central neurological disease.
- Previous surgery involving the facial nerve.
- History of head and neck malignancy and/or chemotherapy or radiotherapy that could potentially affect facial nerve function.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Ankara
About this study
Official title: Comparison of the Clinical Effectiveness of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following Temporomandibular Joint Surgery
This randomized clinical trial compared two photobiomodulation systems for the management of postoperative facial nerve dysfunction following temporomandibular joint surgery. Patients who developed clinically detectable facial nerve dysfunction after open temporomandibular joint surgery were randomly assigned to receive photobiomodulation using either the GRR Laser system or the SiroLaser Advance Plus system. Photobiomodulation was initiated on the first postoperative day and consisted of 15 treatment sessions. Facial nerve recovery was evaluated using the House-Brackmann Grading System, the Sunnybrook Facial Grading System, and the Facial Clinimetric Evaluation (FaCE) Scale during a 60-day follow-up period.
Read the detailed description
This prospective, randomized, parallel-group clinical trial was conducted in patients who developed postoperative facial nerve dysfunction following open temporomandibular joint surgery. Eligible participants were randomly allocated in a 1:1 ratio to one of two active photobiomodulation treatment groups using a computer-generated block randomization sequence.
Participants assigned to the GRR Laser group received extraoral transcutaneous photobiomodulation using a dual-wavelength 650-nm and 904-nm laser/LED system. Participants assigned to the SiroLaser Advance Plus group received extraoral transcutaneous photobiomodulation using a 660-nm continuous-wave diode laser. In both groups, irradiation was applied along the anatomical projection of the clinically affected facial nerve branches on the operated side.
Photobiomodulation treatment was initiated on the first postoperative day. Treatment was administered daily during the first five postoperative days and every other day thereafter, for a total of 15 treatment sessions. Each treatment session lasted approximately 10 minutes.
Facial nerve function was evaluated on postoperative days 5, 7, 10, 30, and 60. Clinical assessments included the House-Brackmann Grading System and the Sunnybrook Facial Grading System. Patient-reported functional status and quality of life were assessed using the Facial Clinimetric Evaluation (FaCE) Scale. The first standardized outcome assessment was performed on postoperative day 5; therefore, this assessment represented the first standardized postoperative evaluation rather than a pretreatment baseline.
- Conditions
- Postoperative Facial Nerve Dysfunction
- Being tested
- GRR Laser Photobiomodulation System, SiroLaser Advance Plus
- Keywords
- Facial Nerve Dysfunction, Temporomandibular Joint Surgery, Photobiomodulation Therapy, Low-Level Laser Therapy, Facial Nerve Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRR Laser Photobiomodulation SystemDevice
Extraoral transcutaneous photobiomodulation was delivered using the GRR Laser system, a dual-wavelength 650-nm and 904-nm laser/LED system. Treatment was applied along the anatomical projection of the clinically affected facial nerve branches. Treatment began on the first postoperative day and consisted of 15 sessions, administered daily during the first 5 postoperative days and every other day thereafter. Each session lasted approximately 10 minutes.
SiroLaser Advance PlusDevice
Extraoral transcutaneous photobiomodulation was delivered using the SiroLaser Advance Plus system in SoftLase mode. Irradiation was provided using a 660-nm continuous-wave diode laser with an output power of 25 mW through an 8-mm fiber-optic tip. Treatment was applied along the anatomical projection of the clinically affected facial nerve branches. Treatment began on the first postoperative day and consisted of 15 sessions using the same treatment schedule as the GRR Laser group.
| Study group | Role | What they receive |
|---|---|---|
| SiroLaser Advance Plus Group | Active comparator | Participants received photobiomodulation using the SiroLaser Advance Plus system. Receives: Device: SiroLaser Advance Plus |
| GRR Laser Group | Experimental | Participants received photobiomodulation using the GRR Laser system. Receives: Device: GRR Laser Photobiomodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sunnybrook Facial Grading System Score
The Sunnybrook Facial Grading System was used to assess facial nerve function based on resting symmetry, voluntary facial movement, and synkinesis. The composite score ranges from 0 to 100, with higher scores indicating better facial nerve function. The change score was calculated as the postoperative day 60 score minus the postoperative day 5 score.
Measured: From postoperative day 5 to postoperative day 60
Secondary outcomes (2)
House-Brackmann Grading System
Facial nerve function was graded using the House-Brackmann Grading System, which classifies facial nerve function from Grade I (normal function) to Grade VI (complete paralysis), with higher grades indicating greater dysfunction.
Measured: Postoperative days 5, 7, 10, 30, and 60
Facial Clinimetric Evaluation (FaCE) Scale
The FaCE Scale is a 15-item patient-reported measure assessing facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function. Total scores are transformed to a 0-100 scale, with higher scores indicating better facial function and quality of life.
Measured: Postoperative days 5, 7, 10, 30, and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start12 May 2022
- Primary completion22 Jun 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Facial Nerve DysfunctionStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Participants were randomized in a 1:1 ratio to one of two parallel active photobiomodulation treatment groups.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Emre Yurttutan, Ankara University
- Investigators
- Mehmet Emre Yurttutan, DDS, PhD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771933
- Sponsor's protocol ID
- AU-TMJ-PBM-2022
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no prospective data-sharing plan was established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effectiveness of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following Temporomandibular Joint Surgery
- ClinicalTrials.gov ID
- NCT07771933
- Acronym / sponsor ID
- AU-TMJ-PBM-2022
- Conditions
- Postoperative Facial Nerve Dysfunction
- Keywords
- Facial Nerve Dysfunction, Temporomandibular Joint Surgery, Photobiomodulation Therapy, Low-Level Laser Therapy, Facial Nerve Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 19 Aug 2026 (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.
This randomized clinical trial compared two photobiomodulation systems for the management of postoperative facial nerve dysfunction following temporomandibular joint surgery. Patients who developed clinically detectable facial nerve dysfunction after open temporomandibular joint surgery were randomly assigned to receive photobiomodulation using either the GRR Laser system or the SiroLaser Advance Plus system. Photobiomodulation was initiated on the first postoperative day and consisted of 15 treatment sessions. Facial nerve recovery was evaluated using the House-Brackmann Grading System, the Sunnybrook Facial Grading System, and the Facial Clinimetric Evaluation (FaCE) Scale during a 60-day follow-up period.
Detailed description
This prospective, randomized, parallel-group clinical trial was conducted in patients who developed postoperative facial nerve dysfunction following open temporomandibular joint surgery. Eligible participants were randomly allocated in a 1:1 ratio to one of two active photobiomodulation treatment groups using a computer-generated block randomization sequence.
Participants assigned to the GRR Laser group received extraoral transcutaneous photobiomodulation using a dual-wavelength 650-nm and 904-nm laser/LED system. Participants assigned to the SiroLaser Advance Plus group received extraoral transcutaneous photobiomodulation using a 660-nm continuous-wave diode laser. In both groups, irradiation was applied along the anatomical projection of the clinically affected facial nerve branches on the operated side.
Photobiomodulation treatment was initiated on the first postoperative day. Treatment was administered daily during the first five postoperative days and every other day thereafter, for a total of 15 treatment sessions. Each treatment session lasted approximately 10 minutes.
Facial nerve function was evaluated on postoperative days 5, 7, 10, 30, and 60. Clinical assessments included the House-Brackmann Grading System and the Sunnybrook Facial Grading System. Patient-reported functional status and quality of life were assessed using the Facial Clinimetric Evaluation (FaCE) Scale. The first standardized outcome assessment was performed on postoperative day 5; therefore, this assessment represented the first standardized postoperative evaluation rather than a pretreatment baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to one of two parallel active photobiomodulation treatment groups.
| Arm | Type | Receives |
|---|---|---|
| SiroLaser Advance Plus Group | Active comparator | Device: SiroLaser Advance PlusParticipants received photobiomodulation using the SiroLaser Advance Plus system. |
| GRR Laser Group | Experimental | Device: GRR Laser Photobiomodulation SystemParticipants received photobiomodulation using the GRR Laser system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent open temporomandibular joint surgery.
- Presence of clinically confirmed postoperative facial nerve dysfunction.
- Willingness to comply with the follow-up protocol and attend scheduled follow-up visits.
- Provision of written informed consent.
Key exclusion criteria (4 listed)
- Pre-existing facial nerve paralysis or facial nerve dysfunction before surgery.
- History of central neurological disease.
- Previous surgery involving the facial nerve.
- History of head and neck malignancy and/or chemotherapy or radiotherapy that could potentially affect facial nerve function.
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 |
|---|---|---|
| GRR Laser Photobiomodulation SystemExtraoral transcutaneous photobiomodulation was delivered using the GRR Laser system, a dual-wavelength 650-nm and 904-nm laser/LED system. Treatment was applied along the anatomical projection of the clinically affected facial nerve branches. Treatment began on the first postoperative day and consisted of 15 sessions, administered daily during the first 5 postoperative days and every other day thereafter. Each session lasted approximately 10 minutes. | Device | GRR Laser Group |
| SiroLaser Advance PlusExtraoral transcutaneous photobiomodulation was delivered using the SiroLaser Advance Plus system in SoftLase mode. Irradiation was provided using a 660-nm continuous-wave diode laser with an output power of 25 mW through an 8-mm fiber-optic tip. Treatment was applied along the anatomical projection of the clinically affected facial nerve branches. Treatment began on the first postoperative day and consisted of 15 sessions using the same treatment schedule as the GRR Laser group. | Device | SiroLaser Advance Plus Group |
Primary outcome
Change in Sunnybrook Facial Grading System Score
Time frame: From postoperative day 5 to postoperative day 60
The Sunnybrook Facial Grading System was used to assess facial nerve function based on resting symmetry, voluntary facial movement, and synkinesis. The composite score ranges from 0 to 100, with higher scores indicating better facial nerve function. The change score was calculated as the postoperative day 60 score minus the postoperative day 5 score.
2 secondary outcomes
House-Brackmann Grading System
Time frame: Postoperative days 5, 7, 10, 30, and 60
Facial Clinimetric Evaluation (FaCE) Scale
Time frame: Postoperative days 5, 7, 10, 30, and 60
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no prospective data-sharing plan was established for this study.
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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.
Mehmet Emre Yurttutan, DDS, PhD principal investigator
Ankara 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 GRR Laser Photobiomodulation System and SiroLaser Advance Plus in people with Postoperative Facial Nerve Dysfunction, run by Ankara University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 19 Aug 2026. 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 Turkey (Türkiye). 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?
Change in Sunnybrook Facial Grading System Score (time frame: From postoperative day 5 to postoperative day 60). 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 19 Aug 2026.