Photobiomodulation TherapyNCT06841120
Reversal of Anaesthesia with Diode Laser
A study testing Actual laser application in people with Photobiomodulation Therapy, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Background: After local anesthesia, which is frequently used in pediatric dentistry, long-term soft tissue numbness can cause various problems. The aim of this study was to evaluate the effectiveness of PBMT in reversing soft tissue anaesthesia in children following local anaesthesia administration. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Photobiomodulation Therapy
- What is being tested?
- Actual laser application
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2023to 30 Apr 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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- - Children whose parents signed the written informed consent form and who themselves gave assent,
- Children with a Frankl behaviour rating scale score of 3 or 4,
- Children aged between 4 and 9 years old who can understand soft tissue sensation and respond to it,
- Children requiring treatment with local infiltration anaesthesia for multiple teeth in both the mandible and maxilla,
- Children with no history of allergy to materials used for anaesthesia or sulphite,
- Children who have not taken any analgesic medication at least 24 hours before treatment,
- Children without any systemic conditions that would interfere with dental treatment under local anaesthesia.
Who cannot join
- Occurrence of an error during anaesthesia injection resulting in insufficient anaesthesia for treatment,
- Inability of the patient to provide clear assessments of response to soft tissue anaesthesia,
- Presence of systemic conditions that would prevent anaesthesia administration or dental treatment,
- Children requiring urgent dental treatment priority such as acute painful teeth.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University, Faculty of Dentistry
Rize, Rize Province, 53100
About this study
Official title: Evaluation of Photobiomodulation Therapy with Diode Laser in Reversal of Maxillary and Mandibular Soft Tissue Local Anaesthesia in Paediatric Dentistry: Randomized Clinical Trial:a Randomized Clinical Trial
Background: After local anesthesia, which is frequently used in pediatric dentistry, long-term soft tissue numbness can cause various problems. The aim of this study was to evaluate the effectiveness of PBMT in reversing soft tissue anaesthesia in children following local anaesthesia administration.
Methods: In a split-mouth randomized study, 40 children aged 4 to 9 years, eligible to receive local infiltration injection on both maxillary (n=20) and mandibular (n=20) right and left sides, will included. Maxillary and mandibular quadrants will be randomly assigned to laser or sham laser groups. Normality will assessed using the Kolmogorov-Smirnov test. Categorical variables between laser and control groups will compared using the McNemar paired sample test. Significance will be set at p<0.05.
- Conditions
- Photobiomodulation Therapy
- Being tested
- Actual laser application, Sham laser application
- Keywords
- photobiomodulation therapy, diode laser, dental local anaesthesia, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actual laser applicationDevice
At approximately 45 minutes into the treatment session, subjects in the laser group received irradiation from a 4 W power, 810 nm diode laser (Fox; ARC Laser, GmbH, Nürnberg, Germany). The laser was operated in continuous mode, delivering 12-second shots per point using a therapy head with a point size of 0.38 cm². Each point received 6.3 J/cm² of laser energy, resulting in a total energy density of 37.8 J/cm² across 6 points.
Sham laser applicationDevice
Sham laser was applied symbolically as a diffused closed laser (targeted beam) at the same distance and simultaneously. Evaluations after laser irradiation were conducted by a responsible specialist physician who was not involved in performing the treatment procedures.
| Study group | Role | What they receive |
|---|---|---|
| Actual laser application | Experimental | Not described Receives: Device: Actual laser application |
| Sham laser was applied symbolically | Sham comparator | Not described Receives: Device: Sham laser application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia reversal time
Until the first reversal of anesthesia, a palpation technique will be used to record every 10 minutes. With this technique, the presence of a sense of touch and tingling will be questioned. In order to obtain an objective answer, the child will be asked whether he/she knows what a tingling sensation is based on his/her previous experiences and will be told what and how this sensation is.
Measured: up to 30 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start18 Jan 2023
- Primary completion18 Jan 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Photobiomodulation TherapyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Kurt, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841120
- Sponsor's protocol ID
- RecepTayyipErdoganUniversity
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurt A, Kibaroglu E, Yildirim H, Gumrukcu Z, Balaban E. Effect of 810-nm diode laser photobiomodulation on the reversal of maxillary and mandibular soft tissue local anaesthesia in children: a randomized split-mouth clinical trial. Sci Rep. 2026 Jul 13. doi: 10.1038/s41598-026-62428-z. Online ahead of print.
PubMed 42443404
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Photobiomodulation Therapy with Diode Laser in Reversal of Maxillary and Mandibular Soft Tissue Local Anaesthesia in Paediatric Dentistry: Randomized Clinical Trial:a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06841120
- Acronym / sponsor ID
- RecepTayyipErdoganUniversity
- Conditions
- Photobiomodulation Therapy
- Keywords
- photobiomodulation therapy, diode laser, dental local anaesthesia, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 24 Feb 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.
Background: After local anesthesia, which is frequently used in pediatric dentistry, long-term soft tissue numbness can cause various problems. The aim of this study was to evaluate the effectiveness of PBMT in reversing soft tissue anaesthesia in children following local anaesthesia administration.
Methods: In a split-mouth randomized study, 40 children aged 4 to 9 years, eligible to receive local infiltration injection on both maxillary (n=20) and mandibular (n=20) right and left sides, will included. Maxillary and mandibular quadrants will be randomly assigned to laser or sham laser groups. Normality will assessed using the Kolmogorov-Smirnov test. Categorical variables between laser and control groups will compared using the McNemar paired sample test. Significance will be set at p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actual laser application | Experimental | Device: Actual laser application |
| Sham laser was applied symbolically | Sham comparator | Device: Sham laser application |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- - Children whose parents signed the written informed consent form and who themselves gave assent,
- Children with a Frankl behaviour rating scale score of 3 or 4,
- Children aged between 4 and 9 years old who can understand soft tissue sensation and respond to it,
- Children requiring treatment with local infiltration anaesthesia for multiple teeth in both the mandible and maxilla,
- Children with no history of allergy to materials used for anaesthesia or sulphite,
Key exclusion criteria (4 listed)
- Occurrence of an error during anaesthesia injection resulting in insufficient anaesthesia for treatment,
- Inability of the patient to provide clear assessments of response to soft tissue anaesthesia,
- Presence of systemic conditions that would prevent anaesthesia administration or dental treatment,
- Children requiring urgent dental treatment priority such as acute painful teeth.
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 |
|---|---|---|
| Actual laser applicationAt approximately 45 minutes into the treatment session, subjects in the laser group received irradiation from a 4 W power, 810 nm diode laser (Fox; ARC Laser, GmbH, Nürnberg, Germany). The laser was operated in continuous mode, delivering 12-second shots per point using a therapy head with a point size of 0.38 cm². Each point received 6.3 J/cm² of laser energy, resulting in a total energy density of 37.8 J/cm² across 6 points. | Device | Actual laser application |
| Sham laser applicationSham laser was applied symbolically as a diffused closed laser (targeted beam) at the same distance and simultaneously. Evaluations after laser irradiation were conducted by a responsible specialist physician who was not involved in performing the treatment procedures. | Device | Sham laser was applied symbolically |
Primary outcome
Anesthesia reversal time
Time frame: up to 30 minutes after procedure
Until the first reversal of anesthesia, a palpation technique will be used to record every 10 minutes. With this technique, the presence of a sense of touch and tingling will be questioned. In order to obtain an objective answer, the child will be asked whether he/she knows what a tingling sensation is based on his/her previous experiences and will be told what and how this sensation is.
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 24 Feb 2025.
- Derived from this study: PubMed 42443404Kurt A, Kibaroglu E, Yildirim H, Gumrukcu Z, Balaban E. Effect of 810-nm diode laser photobiomodulation on the reversal of maxillary and mandibular soft tissue local anaesthesia in children: a randomized split-mouth clinical trial. Sci Rep. 2026 Jul 13. doi: 10.1038/s41598-026-62428-z. Online ahead of print.
- Individual participant dataSharing planned: No
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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 study testing Actual laser application in people with Photobiomodulation Therapy, run by Recep Tayyip Erdogan 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 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 24 Feb 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. Some participants in this study may receive a placebo. 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?
Anesthesia reversal time (time frame: up to 30 minutes after procedure). 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 NCT06841120, which also lists 1 linked publication.
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 24 Feb 2025.