Inferior Alveolar Nerve InjuriesPhase 4NCT06893497
Does Low-level Laser Therapy Protocol Affect the Efficacy of Treatment of Inferior Alveolar Nerve Injury After Maxillofacial Surgery
A Phase 4 study testing Low Level Laser Therapy in people with Inferior Alveolar Nerve Injuries, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Dear Patient, Dear Parent / Guardian; This consent form has been prepared to enlighten you about the nature of the diagnosis and treatment methods that have been explained to you/patient and will be applied, the expected benefits of the procedures, possible side effects, alternative diagnosis and treatment options and… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Inferior Alveolar Nerve Injuries
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2019to 15 Jan 2024
- Phase
- Phase 4
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with unilateral or bilateral inferior alveolar nerve damage caused by maxillofacial surgery and receiving DESL treatment
- Patients with a follow-up period of at least 6 months
- Patients whose diagnosis has been confirmed by clinical neurosensory testing
- Patients with complete study data and follow-up
- Patients who have not previously undergone any microsurgical or conservative treatment in the head and neck region due to nerve damage
- Patients without known neurological disease that may affect the study results
- Patients without active infection (pain, temperature increase, redness, edema, loss of function, etc.) or pathological findings (tumour, cyst, etc.) in the relevant area were included.
Who cannot join
- Patients with nerve damage due to other reasons (pathology, infection, etc.) before maxillofacial surgery
- Patients with lingual nerve damage
- Patients with known neurological disease that may affect the study results
- Patients with missing data or patients who cannot be followed up
- Pregnant patients were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Dear Patient, Dear Parent / Guardian; This consent form has been prepared to enlighten you about the nature of the diagnosis and treatment methods that have been explained to you/patient and will be applied, the expected benefits of the procedures, possible side effects, alternative diagnosis and treatment options and their characteristics, and the consequences that may arise if these procedures are not performed and to obtain your consent. By reading and signing this form, you declare that you have been informed about the procedure and that you freely consent to the procedure. You can ask your doctor about the points you do not understand in the form. Please bring this form with you on the day of your appointment and hand it to your doctor.
WHAT YOU NEED TO KNOW DIAGNOSIS AND PROCEDURE: Low-level laser therapy will be applied for the treatment of sensory impairment resulting from maxillofacial surgery.
Read more
WHO WILL PERFORM YOUR PROCEDURE? This procedure will be performed by the physicians working in Karadeniz Technical University Faculty of Dentistry, Oral, Dental and Maxillofacial Surgery. I also accept that KTU Faculty of Dentistry is an educational institution and that my treatment can be used to contribute to the education of interns and that they can participate in my operation.
EXPECTED BENEFITS OF THE PROCEDURE To contribute to the nerve regeneration of the patient whose quality of life has deteriorated due to sensory damage.
PROBLEMS THAT MAY BE ENCOUNTERED IF THE PROCEDURE IS NOT PERFORMED There is no risk associated with low-level laser treatment.
ALTERNATIVES TO THE PROCEDURE, IF ANY: There is no alternative treatment.
possible risks and complications of the procedure Treatment approaches to nerve injuries are divided into two as surgical and non-surgical treatment approaches. Surgical treatment approaches include decompression, resection of neuroma, internal neurolysis, neurorrhaphy, nerve grafts and intubation techniques. However, since there is a risk of complications after surgical treatment, non-surgical treatment approaches are primarily preferred. Non-surgical treatment approaches include pharmacological treatment, acupuncture, moxibustion and low-level laser (DSL) treatment.
ESTIMATED DURATION OF THE PROCEDURE: 15-30 minutes.
- Conditions
- Inferior Alveolar Nerve Injuries
- Being tested
- Low Level Laser Therapy
- Medical subject headings
- Mandibular Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
In this study, which had more patients than other studies, different parameters were evaluated to determine the protocol of LLL therapy. These parameters were the cause of IAN injury, number of sessions, time of treatment start and period of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Patients with different sessions, start time and cause of IAN injury were compared. | Experimental | Low level laser therapy was applied to all patients. Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Visual Analog Scale (VAS)
All patients underwent preoperative and postoperative clinical neurosensory testing (CNT), comprising three levels of evaluation. Level A: two-point discrimination, where the minimum distinguishable distance (15 mm, 10 mm, and 5 mm) was measured using slight skin pressure. Level B: light touch assessment, where a blunt-tipped tool was applied to 10 points on the lower lip, recording detected stimuli. Level C: pin-prick nociception, where forceps compression assessed pain perception at 10 points. A subjective neurosensory deficit assessment was conducted using the Visual Analog Scale (VAS), a 100 mm horizontal line ranging from 0 (no sensation) to 100 (normal sensation), with descriptors at both ends.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start15 Jan 2019
- Primary completion15 Jan 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Inferior Alveolar Nerve InjuriesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Ateş, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893497
- Sponsor's protocol ID
- 2022/8
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Guarini D, Gracia B, Ramirez-Lobos V, Noguera-Pantoja A, Sole-Ventura P. Laser Biophotomodulation in Patients with Neurosensory Disturbance of the Inferior Alveolar Nerve After Sagittal Split Ramus Osteotomy: A 2-Year Follow-Up Study. Photomed Laser Surg. 2018 Jan;36(1):3-9. doi: 10.1089/pho.2017.4312. Epub 2017 Oct 12.
PubMed 29022844Favaro-Pipi E, Feitosa SM, Ribeiro DA, Bossini P, Oliveira P, Parizotto NA, Renno AC. Comparative study of the effects of low-intensity pulsed ultrasound and low-level laser therapy on bone defects in tibias of rats. Lasers Med Sci. 2010 Sep;25(5):727-32. doi: 10.1007/s10103-010-0772-2. Epub 2010 Jun 3.
PubMed 20521077Miloro M, Repasky M. Low-level laser effect on neurosensory recovery after sagittal ramus osteotomy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jan;89(1):12-8. doi: 10.1016/s1079-2104(00)80006-2.
PubMed 10630935Moore KC., Hira N., Kumar PS., Jayakumar CS., Ohshiro T. A Double Blind Crossover Trial of low Level Laser Therapy in the Treatment of Postherpetic Neuralgia. Laser Ther 2004;14:61-4. Doi: 10.5978/ISLSM.14.0_61.
Kahraman SA. Low-level laser therapy in oral and maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2004 May;16(2):277-88. doi: 10.1016/j.coms.2004.02.002. No abstract available.
PubMed 18088730Sun G, Tuner J. Low-level laser therapy in dentistry. Dent Clin North Am. 2004 Oct;48(4):1061-76, viii. doi: 10.1016/j.cden.2004.05.004.
PubMed 15464564Mohajerani SH, Tabeie F, Bemanali M, Tabrizi R. Effect of Low-Level Laser and Light-Emitting Diode on Inferior Alveolar Nerve Recovery After Sagittal Split Osteotomy of the Mandible: A Randomized Clinical Trial Study. J Craniofac Surg. 2017 Jun;28(4):e408-e411. doi: 10.1097/SCS.0000000000002929.
PubMed 28538060Ozen T, Orhan K, Gorur I, Ozturk A. Efficacy of low level laser therapy on neurosensory recovery after injury to the inferior alveolar nerve. Head Face Med. 2006 Feb 15;2:3. doi: 10.1186/1746-160X-2-3.
PubMed 16480503Robinson PP, Loescher AR, Yates JM, Smith KG. Current management of damage to the inferior alveolar and lingual nerves as a result of removal of third molars. Br J Oral Maxillofac Surg. 2004 Aug;42(4):285-92. doi: 10.1016/j.bjoms.2004.02.024.
PubMed 15225944Esteves Pinto Faria P, Temprano A, Piva F, Sant'ana E, Pimenta D. Low-level laser therapy for neurosensory recovery after sagittal ramus osteotomy. Minerva Stomatol. 2020 Jun;69(3):141-147. doi: 10.23736/S0026-4970.20.04289-2. Epub 2020 Mar 16.
PubMed 32181610Miloro M, Criddle TR. Does Low-Level Laser Therapy Affect Recovery of Lingual and Inferior Alveolar Nerve Injuries? J Oral Maxillofac Surg. 2018 Dec;76(12):2669-2675. doi: 10.1016/j.joms.2018.06.001. Epub 2018 Jun 11.
PubMed 30509397Lomke MA. Clinical applications of dental lasers. Gen Dent. 2009 Jan-Feb;57(1):47-59.
PubMed 19146143
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Low-level Laser Therapy Protocol Affect the Efficacy of Treatment of Inferior Alveolar Nerve Injury After Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT06893497
- Acronym / sponsor ID
- 2022/8
- Conditions
- Inferior Alveolar Nerve Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 25 Mar 2025 (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.
Dear Patient, Dear Parent / Guardian; This consent form has been prepared to enlighten you about the nature of the diagnosis and treatment methods that have been explained to you/patient and will be applied, the expected benefits of the procedures, possible side effects, alternative diagnosis and treatment options and their characteristics, and the consequences that may arise if these procedures are not performed and to obtain your consent. By reading and signing this form, you declare that you have been informed about the procedure and that you freely consent to the procedure. You can ask your doctor about the points you do not understand in the form. Please bring this form with you on the day of your appointment and hand it to your doctor.
WHAT YOU NEED TO KNOW DIAGNOSIS AND PROCEDURE: Low-level laser therapy will be applied for the treatment of sensory impairment resulting from maxillofacial surgery.
WHO WILL PERFORM YOUR PROCEDURE? This procedure will be performed by the physicians working in Karadeniz Technical University Faculty of Dentistry, Oral, Dental and Maxillofacial Surgery. I also accept that KTU Faculty of Dentistry is an educational institution and that my treatment can be used to contribute to the education of interns and that they can participate in my operation.
EXPECTED BENEFITS OF THE PROCEDURE To contribute to the nerve regeneration of the patient whose quality of life has deteriorated due to sensory damage.
PROBLEMS THAT MAY BE ENCOUNTERED IF THE PROCEDURE IS NOT PERFORMED There is no risk associated with low-level laser treatment.
ALTERNATIVES TO THE PROCEDURE, IF ANY: There is no alternative treatment.
possible risks and complications of the procedure Treatment approaches to nerve injuries are divided into two as surgical and non-surgical treatment approaches. Surgical treatment approaches include decompression, resection of neuroma, internal neurolysis, neurorrhaphy, nerve grafts and intubation techniques. However, since there is a risk of complications after surgical treatment, non-surgical treatment approaches are primarily preferred. Non-surgical treatment approaches include pharmacological treatment, acupuncture, moxibustion and low-level laser (DSL) treatment.
ESTIMATED DURATION OF THE PROCEDURE: 15-30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with different sessions, start time and cause of IAN injury were compared. | Experimental | Device: Low Level Laser TherapyLow level laser therapy was applied to all patients. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with unilateral or bilateral inferior alveolar nerve damage caused by maxillofacial surgery and receiving DESL treatment
- Patients with a follow-up period of at least 6 months
- Patients whose diagnosis has been confirmed by clinical neurosensory testing
- Patients with complete study data and follow-up
- Patients who have not previously undergone any microsurgical or conservative treatment in the head and neck region due to nerve damage
Key exclusion criteria (5 listed)
- Patients with nerve damage due to other reasons (pathology, infection, etc.) before maxillofacial surgery
- Patients with lingual nerve damage
- Patients with known neurological disease that may affect the study results
- Patients with missing data or patients who cannot be followed up
- Pregnant patients were not included in the study.
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 |
|---|---|---|
| Low Level Laser TherapyIn this study, which had more patients than other studies, different parameters were evaluated to determine the protocol of LLL therapy. These parameters were the cause of IAN injury, number of sessions, time of treatment start and period of follow-up. | Device | Patients with different sessions, start time and cause of IAN injury were compared. |
Primary outcome
the Visual Analog Scale (VAS)
Time frame: up to 2 years
All patients underwent preoperative and postoperative clinical neurosensory testing (CNT), comprising three levels of evaluation. Level A: two-point discrimination, where the minimum distinguishable distance (15 mm, 10 mm, and 5 mm) was measured using slight skin pressure. Level B: light touch assessment, where a blunt-tipped tool was applied to 10 points on the lower lip, recording detected stimuli. Level C: pin-prick nociception, where forceps compression assessed pain perception at 10 points. A subjective neurosensory deficit assessment was conducted using the Visual Analog Scale (VAS), a 100 mm horizontal line ranging from 0 (no sensation) to 100 (normal sensation), with descriptors at both ends.
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 25 Mar 2025.
- Results publication: PubMed 29022844Guarini D, Gracia B, Ramirez-Lobos V, Noguera-Pantoja A, Sole-Ventura P. Laser Biophotomodulation in Patients with Neurosensory Disturbance of the Inferior Alveolar Nerve After Sagittal Split Ramus Osteotomy: A 2-Year Follow-Up Study. Photomed Laser Surg. 2018 Jan;36(1):3-9. doi: 10.1089/pho.2017.4312. Epub 2017 Oct 12.
- Results publication: PubMed 20521077Favaro-Pipi E, Feitosa SM, Ribeiro DA, Bossini P, Oliveira P, Parizotto NA, Renno AC. Comparative study of the effects of low-intensity pulsed ultrasound and low-level laser therapy on bone defects in tibias of rats. Lasers Med Sci. 2010 Sep;25(5):727-32. doi: 10.1007/s10103-010-0772-2. Epub 2010 Jun 3.
- Results publication: PubMed 10630935Miloro M, Repasky M. Low-level laser effect on neurosensory recovery after sagittal ramus osteotomy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jan;89(1):12-8. doi: 10.1016/s1079-2104(00)80006-2.
- Results publicationMoore KC., Hira N., Kumar PS., Jayakumar CS., Ohshiro T. A Double Blind Crossover Trial of low Level Laser Therapy in the Treatment of Postherpetic Neuralgia. Laser Ther 2004;14:61-4. Doi: 10.5978/ISLSM.14.0_61.
- Results publication: PubMed 18088730Kahraman SA. Low-level laser therapy in oral and maxillofacial surgery. Oral Maxillofac Surg Clin North Am. 2004 May;16(2):277-88. doi: 10.1016/j.coms.2004.02.002. No abstract available.
- Results publication: PubMed 15464564Sun G, Tuner J. Low-level laser therapy in dentistry. Dent Clin North Am. 2004 Oct;48(4):1061-76, viii. doi: 10.1016/j.cden.2004.05.004.
- Results publication: PubMed 28538060Mohajerani SH, Tabeie F, Bemanali M, Tabrizi R. Effect of Low-Level Laser and Light-Emitting Diode on Inferior Alveolar Nerve Recovery After Sagittal Split Osteotomy of the Mandible: A Randomized Clinical Trial Study. J Craniofac Surg. 2017 Jun;28(4):e408-e411. doi: 10.1097/SCS.0000000000002929.
- Results publication: PubMed 16480503Ozen T, Orhan K, Gorur I, Ozturk A. Efficacy of low level laser therapy on neurosensory recovery after injury to the inferior alveolar nerve. Head Face Med. 2006 Feb 15;2:3. doi: 10.1186/1746-160X-2-3.
- Results publication: PubMed 15225944Robinson PP, Loescher AR, Yates JM, Smith KG. Current management of damage to the inferior alveolar and lingual nerves as a result of removal of third molars. Br J Oral Maxillofac Surg. 2004 Aug;42(4):285-92. doi: 10.1016/j.bjoms.2004.02.024.
- Results publication: PubMed 32181610Esteves Pinto Faria P, Temprano A, Piva F, Sant'ana E, Pimenta D. Low-level laser therapy for neurosensory recovery after sagittal ramus osteotomy. Minerva Stomatol. 2020 Jun;69(3):141-147. doi: 10.23736/S0026-4970.20.04289-2. Epub 2020 Mar 16.
- Results publication: PubMed 30509397Miloro M, Criddle TR. Does Low-Level Laser Therapy Affect Recovery of Lingual and Inferior Alveolar Nerve Injuries? J Oral Maxillofac Surg. 2018 Dec;76(12):2669-2675. doi: 10.1016/j.joms.2018.06.001. Epub 2018 Jun 11.
- Results publication: PubMed 19146143Lomke MA. Clinical applications of dental lasers. Gen Dent. 2009 Jan-Feb;57(1):47-59.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low Level Laser Therapy in people with Inferior Alveolar Nerve Injuries, run by Karadeniz Technical 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 7 inclusion and 5 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 25 Mar 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the Visual Analog Scale (VAS) (time frame: up to 2 years). 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 NCT06893497, which also lists 12 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 25 Mar 2025.