Fear NeedlesNCT06128590
Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain
A study testing Photobiomodulation, Mepivacaine hydrochloride in combination with epinephrine and Photobiomodulation simulation in people with Fear Needles, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The objective of this study is to assess whether pre-anesthetic photobiomodulation (PBM) can effectively reduce needle puncture pain and enhance the efficiency of local anesthesia. In this double-blind randomized controlled trial, 50 participants were included. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear Needles
- What is being tested?
- Photobiomodulation, Mepivacaine hydrochloride in combination with epinephrine and Photobiomodulation simulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2023to 20 Feb 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 18 to 60 years old
- Both genders
- Without comorbidities
- Who required pterygomandibular anaesthesia for a dental procedure.
Who cannot join
- Any sign of pain or inflammation at the puncture site (e.g. presence of pericoronaritis)
- Active periodontitis/gingivitis
- Use of a pacemaker
- Use of prostheses, fixed metal appliances
- Using anti-inflammatory, analgesic or corticosteroid therapy for less than 1 week.
- Pregnant and/or breastfeeding women
- Need to use a local anaesthetic other than Mepivacaine with vasoconstrictor (anaesthetic of choice for the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain: A Double-Blind, Randomized Controlled Clinical Study
The objective of this study is to assess whether pre-anesthetic photobiomodulation (PBM) can effectively reduce needle puncture pain and enhance the efficiency of local anesthesia. In this double-blind randomized controlled trial, 50 participants were included. The control group underwent the standard anesthetic procedure, while the experimental group received the application of an infrared laser (100mW at 808nm, 8J at a single point) immediately before anesthesia, at the site of the intended needle puncture. Both groups underwent the same anesthetic procedure, administered by the same operator. The outcome evaluator and the patient were blind to the FBM application. The primary outcome of the study focused on pain experienced at the time of needle insertion, assessed using the Visual Analogue Scale (VAS) during the needle's introduction. Secondary outcomes encompassed anxiety levels, measured using the Beck questionnaire, anesthetic onset time determined through the electric pulp test, the number of anesthetics required for the procedure, and the necessity for supplementary anesthesia.
Read the detailed description
Dental fear and phobia are widespread worldwide, with local anesthesia being one of the procedures that patients fear the most. To alleviate the pain associated with needle insertion and the need for repeat procedures, various complementary therapies have been introduced. However, to date, there is no established protocol for this intervention. The objective of this study is to assess whether pre-anesthetic photobiomodulation (PBM) can effectively reduce needle puncture pain and enhance the efficiency of local anesthesia. In this double-blind randomized controlled trial, 50 participants were included. The control group underwent the standard anesthetic procedure, while the experimental group received the application of an infrared laser (100mW at 808nm, 8J at a single point) immediately before anesthesia, at the site of the intended needle puncture. Both groups underwent the same anesthetic procedure, administered by the same operator. The outcome evaluator and the patient were blind to the FBM application. The primary outcome of the study focused on pain experienced at the time of needle insertion, assessed using the Visual Analogue Scale (VAS) during the needle's introduction. Secondary outcomes encompassed anxiety levels, measured using the Beck questionnaire, anesthetic onset time determined through the electric pulp test, the number of anesthetics required for the procedure, and the necessity for supplementary anesthesia. Categorical variables will be presented as absolute and relative frequencies and compared using the Pearson chi-squared test, likelihood ratio test, or Fisher's exact test. Quantitative variables will be assessed for normality using the Kolmogorov-Smirnov test. Outcome variables will be presented as mean and standard deviation or median and interquartile range (IQR) and compared using the Student's t-test or Mann-Whitney test. Variables measured under multiple conditions will be compared using analysis of variance for repeated measures. A significance level of P < 0.05 will be considered statistically significant.
- Conditions
- Fear Needles
- Being tested
- Photobiomodulation, Mepivacaine hydrochloride in combination with epinephrine, Photobiomodulation simulation
- Keywords
- photobiomodulation, local anesthesics
- Medical subject headings
- Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Photobiomodulation was applied before the procedures at an infrared wavelength of 808nm, at a power of 100mW, 1 point with a total energy of 8J, time of 80s, irradiance of 3.33W/cm² and radiant exposure of 266.66 J/cm2. The application point was on the retromolar region where the needle was inserted to perform the anesthetic, in a single application before the procedure.
The patient and operator were properly protected with goggles in both the control and experimental groups.
Mepivacaine hydrochloride in combination with epinephrineDrug
Also called Local anesthetic
The anesthetic of choice will be Mepivacaine, which is widely used in dentistry with duration between 1.5 and 2 minutes. The maximum recommended dose is 6.6 mg/Kg, not exceeding 400 mg or 11 anesthetic tubes.
It is a sterile injectable solution of 2% mepivacaine hydrochloride (20 mg/mL) in combination with epinephrine 1:100,000 (0.01 mg/mL). Each vial contains 1.8 mL, 36 mg of mepivacaine hydrochloride, and 0.018 mg of epinephrine. All patients will use anesthetics from the same brand (DLA Pharmaceutical LTDA), one of the most widely used on the market. All patients will be anesthetized with tubes from the same batch, one tube per procedure.
Photobiomodulation simulationDevice
The participants will be treated in the same manner as in group A. The person responsible for the application of FBM will simulate the irradiations by placing the device in the same location described for the experimental group, but the equipment will remain turned off. To prevent the participant from identifying their group, the activation sounds of the devices (beeps) will be recorded to simulate the device's operation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Photobiomodulation (Group A) | Experimental | Participants will receive photobiomodulation therapy immediately before local anesthesia, in the same place where the puncture will be performed for pterygomandibular anesthesia. Receives: Device: Photobiomodulation; Drug: Mepivacaine hydrochloride in combination with epinephrine |
| Control: Laser Sham (Group B) | Sham comparator | The participants will be treated in the same way as in group A. The person responsible for applying the PBM will simulate the irradiations by positioning the device in the same place as described for the experimental group, but the equipment will be switched off. So that the participant does not identify the group to which they belong, the device's activation sound (beep) will be simulated by the device itself, which makes the beep sound by pressing the activation button only once. After this, pterygomandibular anesthesia will be carried out in the same way. Receives: Drug: Mepivacaine hydrochloride in combination with epinephrine; Device: Photobiomodulation simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
It will be carried out as follows: the healthcare professional asks the patient to select a point on a line 10cm long, drawn between two extremities to express the intensity of the pain. Patients will be asked to rate "current" pain intensity or, in other cases, pain intensity "in the last 24 hours". The VAS is a simple-to-use assessment tool that does not require sophisticated equipment. It is also highly sensitive in detecting the effects of treatment, and its results can be analyzed using parametric tests. In this study, a plastic band was made for all patients,
Measured: Immediately Before anesthesia
Pain assessment
It will be carried out as follows: the healthcare professional asks the patient to select a point on a line 10cm long, drawn between two extremities to express the intensity of the pain. Patients will be asked to rate "current" pain intensity or, in other cases, pain intensity "in the last 24 hours". The VAS is a simple-to-use assessment tool that does not require sophisticated equipment. It is also highly sensitive in detecting the effects of treatment, and its results can be analyzed using parametric tests. In this study, a plastic band was made for all patients,
Measured: Immediately After anesthesia
Secondary outcomes (16)
Anxiety assessment using Beck's questionnaire
Anxiety analyses will be carried out using the BAI (by Beck, Epstein, Brown \& Steer, 1988), adapted and validated for Brazil by Cunha (2001), which will be applied before and after treatment.
The BAI is a multiple-choice questionnaire containing 21 questions about common anxiety symptoms. The score ranges from 0 to 63, and is classified as minimal anxiety (score: 0-10), mild anxiety (score: 11-20), moderate anxiety (score: 21-30) and severe anxiety (score: 31-63). The questionnaire will be answered by the participants themselves, who will read the questions and answer them manually before starting the research and after the end of the treatment. At the end of the treatment, the score obtained will be calculated and applied to the results collection form.
Measured: Immediately Before anesthesia
Anxiety assessment using Beck's questionnaire
Anxiety analyses will be carried out using the BAI (by Beck, Epstein, Brown \& Steer, 1988), adapted and validated for Brazil by Cunha (2001), which will be applied before and after treatment.
The BAI is a multiple-choice questionnaire containing 21 questions about common anxiety symptoms. The score ranges from 0 to 63, and is classified as minimal anxiety (score: 0-10), mild anxiety (score: 11-20), moderate anxiety (score: 21-30) and severe anxiety (score: 31-63). The questionnaire will be answered by the participants themselves, who will read the questions and answer them manually before starting the research and after the end of the treatment. At the end of the treatment, the score obtained will be calculated and applied to the results collection form.
Measured: Immediately After anesthesia
Latency time
To establish a standard, the tests will be carried out on permanent premolars, with normal reaction scales ranging from 20 to 50. For convenience in terms of ease of visualization, the first lower premolar was preferably chosen; if the element was absent, it was carried out on the second lower premolar. Data was collected before treatment and at 2, 5, 10, 15, 20, 25 and 30 minutes after anaesthesia, timed using a digital stopwatch on a mobile phone.
The thermal test will be carried out before the procedure to double-check the pulp vitality of the elements, as stated in the literature.The cold test will be carried out with cotton wool on the buccal surface of the first premolar or the same as the electrical test, for 15 seconds or until the patient indicates that they feel sensitivity.
Measured: Immediately Before anesthesia
Latency time
To establish a standard, the tests will be carried out on permanent premolars, with normal reaction scales ranging from 20 to 50. For convenience in terms of ease of visualization, the first lower premolar was preferably chosen; if the element was absent, it was carried out on the second lower premolar. Data was collected before treatment and at 2, 5, 10, 15, 20, 25 and 30 minutes after anaesthesia, timed using a digital stopwatch on a mobile phone.
The thermal test will be carried out before the procedure to double-check the pulp vitality of the elements, as stated in the literature.The cold test will be carried out with cotton wool on the buccal surface of the first premolar or the same as the electrical test, for 15 seconds or until the patient indicates that they feel sensitivity.
Measured: 2 minutes after anesthesia
Latency time
To establish a standard, the tests will be carried out on permanent premolars, with normal reaction scales ranging from 20 to 50. For convenience in terms of ease of visualization, the first lower premolar was preferably chosen; if the element was absent, it was carried out on the second lower premolar. Data was collected before treatment and at 2, 5, 10, 15, 20, 25 and 30 minutes after anaesthesia, timed using a digital stopwatch on a mobile phone.
The thermal test will be carried out before the procedure to double-check the pulp vitality of the elements, as stated in the literature.The cold test will be carried out with cotton wool on the buccal surface of the first premolar or the same as the electrical test, for 15 seconds or until the patient indicates that they feel sensitivity.
Measured: 5 minutes after anesthesia
Latency time
To establish a standard, the tests will be carried out on permanent premolars, with normal reaction scales ranging from 20 to 50. For convenience in terms of ease of visualization, the first lower premolar was preferably chosen; if the element was absent, it was carried out on the second lower premolar. Data was collected before treatment and at 2, 5, 10, 15, 20, 25 and 30 minutes after anaesthesia, timed using a digital stopwatch on a mobile phone.
The thermal test will be carried out before the procedure to double-check the pulp vitality of the elements, as stated in the literature.The cold test will be carried out with cotton wool on the buccal surface of the first premolar or the same as the electrical test, for 15 seconds or until the patient indicates that they feel sensitivity.
Measured: 10 minutes after anesthesia
Latency time
To establish a standard, the tests will be carried out on permanent premolars, with normal reaction scales ranging from 20 to 50. For convenience in terms of ease of visualization, the first lower premolar was preferably chosen; if the element was absent, it was carried out on the second lower premolar. Data was collected before treatment and at 2, 5, 10, 15, 20, 25 and 30 minutes after anaesthesia, timed using a digital stopwatch on a mobile phone.
The thermal test will be carried out before the procedure to double-check the pulp vitality of the elements, as stated in the literature.The cold test will be carried out with cotton wool on the buccal surface of the first premolar or the same as the electrical test, for 15 seconds or until the patient indicates that they feel sensitivity.
Measured: 15 minutes after anesthesia
Latency time
To establish a standard, the tests will be carried out on permanent premolars, with normal reaction scales ranging from 20 to 50. For convenience in terms of ease of visualization, the first lower premolar was preferably chosen; if the element was absent, it was carried out on the second lower premolar. Data was collected before treatment and at 2, 5, 10, 15, 20, 25 and 30 minutes after anaesthesia, timed using a digital stopwatch on a mobile phone.
The thermal test will be carried out before the procedure to double-check the pulp vitality of the elements, as stated in the literature.The cold test will be carried out with cotton wool on the buccal surface of the first premolar or the same as the electrical test, for 15 seconds or until the patient indicates that they feel sensitivity.
Measured: 20 minutes after anesthesia
Latency time
To establish a standard, the tests will be carried out on permanent premolars, with normal reaction scales ranging from 20 to 50. For convenience in terms of ease of visualization, the first lower premolar was preferably chosen; if the element was absent, it was carried out on the second lower premolar. Data was collected before treatment and at 2, 5, 10, 15, 20, 25 and 30 minutes after anaesthesia, timed using a digital stopwatch on a mobile phone.
The thermal test will be carried out before the procedure to double-check the pulp vitality of the elements, as stated in the literature.The cold test will be carried out with cotton wool on the buccal surface of the first premolar or the same as the electrical test, for 15 seconds or until the patient indicates that they feel sensitivity.
Measured: 25 minutes after anesthesia
Latency time
To establish a standard, the tests will be carried out on permanent premolars, with normal reaction scales ranging from 20 to 50. For convenience in terms of ease of visualization, the first lower premolar was preferably chosen; if the element was absent, it was carried out on the second lower premolar. Data was collected before treatment and at 2, 5, 10, 15, 20, 25 and 30 minutes after anaesthesia, timed using a digital stopwatch on a mobile phone.
The thermal test will be carried out before the procedure to double-check the pulp vitality of the elements, as stated in the literature.The cold test will be carried out with cotton wool on the buccal surface of the first premolar or the same as the electrical test, for 15 seconds or until the patient indicates that they feel sensitivity.
Measured: 30 minutes after anesthesia
Assessment of blood pressure
A manual sphygmomanometer was used, and assessed by the same professional.
Measured: Immediately Before anesthesia
Assessment of blood pressure
A manual sphygmomanometer was used, and assessed by the same professional.
Measured: 10 minutes after anesthesia
Blood oxygen saturation level
For this purpose, digital oximeter were used, and assessed by the same professional.
Measured: Immediately Before anesthesia
Blood oxygen saturation level
For this purpose, digital oximeter were used, and assessed by the same professional.
Measured: 10 minutes after anesthesia
Pterygomandibular technique success rate
The anesthetic success rate will be calculated by counting the number of times the procedure has been effective, i.e. if 30 minutes after anesthesia, the electrical test does not determine a mark of 50 on the display, this means that the anesthetic technique has failed. Even if the patient reports that the tissues are anesthetized, for complete pterygomandibular anesthesia, it is necessary to anesthetize the pulp, the lingual region, the vestibular region and the corresponding lower lip. If there is no complete anesthesia, this patient will be considered a "failure of anesthesia", but the patient will not be excluded from the study, since the main outcome of pain has already been collected without interference.
Measured: Immediately After procedure
Suplementar anesthesia
Number of anesthetic tubets needed for anesthetic supplementation during the procedure was counted
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Feb 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 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 Fear NeedlesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To randomly allocate participants into the experimental groups, a draw was conducted with 50 numbers using the Sealed Envelope website: https://www.sealedenvelope.com. The distribution was identical (1:1) for both groups, using a blocked design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- Anna Carolina Horliana, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128590
- Sponsor's protocol ID
- 5.598.425
- Status last verified
- Jul 2024
- First submitted
- 7 Nov 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferreira GF, Machado GGA, Roncolato VL, Ramalho KM, Motta LJ, Bussadori SK, Duran CCG, Fernandes KPS, Mesquita Ferrari RA, Chiniforush N, Horliana ACRT. Photobiomodulation therapy on puncture-associated pain: A controlled randomized double-blind clinical trial. Photochem Photobiol. 2025 May-Jun;101(3):771-781. doi: 10.1111/php.14027. Epub 2024 Oct 14.
PubMed 39400883
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain: A Double-Blind, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06128590
- Acronym / sponsor ID
- 5.598.425
- Conditions
- Fear Needles
- Keywords
- photobiomodulation, local anesthesics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 13 Nov 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.
The objective of this study is to assess whether pre-anesthetic photobiomodulation (PBM) can effectively reduce needle puncture pain and enhance the efficiency of local anesthesia. In this double-blind randomized controlled trial, 50 participants were included. The control group underwent the standard anesthetic procedure, while the experimental group received the application of an infrared laser (100mW at 808nm, 8J at a single point) immediately before anesthesia, at the site of the intended needle puncture. Both groups underwent the same anesthetic procedure, administered by the same operator. The outcome evaluator and the patient were blind to the FBM application. The primary outcome of the study focused on pain experienced at the time of needle insertion, assessed using the Visual Analogue Scale (VAS) during the needle's introduction. Secondary outcomes encompassed anxiety levels, measured using the Beck questionnaire, anesthetic onset time determined through the electric pulp test, the number of anesthetics required for the procedure, and the necessity for supplementary anesthesia.
Detailed description
Dental fear and phobia are widespread worldwide, with local anesthesia being one of the procedures that patients fear the most. To alleviate the pain associated with needle insertion and the need for repeat procedures, various complementary therapies have been introduced. However, to date, there is no established protocol for this intervention. The objective of this study is to assess whether pre-anesthetic photobiomodulation (PBM) can effectively reduce needle puncture pain and enhance the efficiency of local anesthesia. In this double-blind randomized controlled trial, 50 participants were included. The control group underwent the standard anesthetic procedure, while the experimental group received the application of an infrared laser (100mW at 808nm, 8J at a single point) immediately before anesthesia, at the site of the intended needle puncture. Both groups underwent the same anesthetic procedure, administered by the same operator. The outcome evaluator and the patient were blind to the FBM application. The primary outcome of the study focused on pain experienced at the time of needle insertion, assessed using the Visual Analogue Scale (VAS) during the needle's introduction. Secondary outcomes encompassed anxiety levels, measured using the Beck questionnaire, anesthetic onset time determined through the electric pulp test, the number of anesthetics required for the procedure, and the necessity for supplementary anesthesia. Categorical variables will be presented as absolute and relative frequencies and compared using the Pearson chi-squared test, likelihood ratio test, or Fisher's exact test. Quantitative variables will be assessed for normality using the Kolmogorov-Smirnov test. Outcome variables will be presented as mean and standard deviation or median and interquartile range (IQR) and compared using the Student's t-test or Mann-Whitney test. Variables measured under multiple conditions will be compared using analysis of variance for repeated measures. A significance level of P < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To randomly allocate participants into the experimental groups, a draw was conducted with 50 numbers using the Sealed Envelope website: https://www.sealedenvelope.com. The distribution was identical (1:1) for both groups, using a blocked design.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Photobiomodulation (Group A) | Experimental | Device: Photobiomodulation, Drug: Mepivacaine hydrochloride in combination with epinephrineParticipants will receive photobiomodulation therapy immediately before local anesthesia, in the same place where the puncture will be performed for pterygomandibular anesthesia. |
| Control: Laser Sham (Group B) | Sham comparator | Drug: Mepivacaine hydrochloride in combination with epinephrine, Device: Photobiomodulation simulationThe participants will be treated in the same way as in group A. The person responsible for applying the PBM will simulate the irradiations by positioning the device in the same place as described for the experimental group, but the equipment will be switched off. So that the participant does not identify the group to which they belong, the device's activation sound (beep) will be simulated by the device itself, which makes the beep sound by pressing the activation button only once. After this, pterygomandibular anesthesia will be carried out in the same way. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- From 18 to 60 years old
- Both genders
- Without comorbidities
- Who required pterygomandibular anaesthesia for a dental procedure.
Key exclusion criteria (7 listed)
- Any sign of pain or inflammation at the puncture site (e.g. presence of pericoronaritis)
- Active periodontitis/gingivitis
- Use of a pacemaker
- Use of prostheses, fixed metal appliances
- Using anti-inflammatory, analgesic or corticosteroid therapy for less than 1 week.
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 |
|---|---|---|
| PhotobiomodulationPhotobiomodulation was applied before the procedures at an infrared wavelength of 808nm, at a power of 100mW, 1 point with a total energy of 8J, time of 80s, irradiance of 3.33W/cm² and radiant exposure of 266.66 J/cm2. The application point was on the retromolar region where the needle was inserted to perform the anesthetic, in a single application before the procedure. The patient and operator were properly protected with goggles in both the control and experimental groups. | Device | Experimental: Photobiomodulation (Group A) |
| Mepivacaine hydrochloride in combination with epinephrineAlso: Local anestheticThe anesthetic of choice will be Mepivacaine, which is widely used in dentistry with duration between 1.5 and 2 minutes. The maximum recommended dose is 6.6 mg/Kg, not exceeding 400 mg or 11 anesthetic tubes. It is a sterile injectable solution of 2% mepivacaine hydrochloride (20 mg/mL) in combination with epinephrine 1:100,000 (0.01 mg/mL). Each vial contains 1.8 mL, 36 mg of mepivacaine hydrochloride, and 0.018 mg of epinephrine. All patients will use anesthetics from the same brand (DLA Pharmaceutical LTDA), one of the most widely used on the market. All patients will be anesthetized with tubes from the same batch, one tube per procedure. | Drug | Control: Laser Sham (Group B), Experimental: Photobiomodulation (Group A) |
| Photobiomodulation simulationThe participants will be treated in the same manner as in group A. The person responsible for the application of FBM will simulate the irradiations by placing the device in the same location described for the experimental group, but the equipment will remain turned off. To prevent the participant from identifying their group, the activation sounds of the devices (beeps) will be recorded to simulate the device's operation. | Device | Control: Laser Sham (Group B) |
Primary outcome
Pain assessment
Time frame: Immediately Before anesthesia
It will be carried out as follows: the healthcare professional asks the patient to select a point on a line 10cm long, drawn between two extremities to express the intensity of the pain. Patients will be asked to rate "current" pain intensity or, in other cases, pain intensity "in the last 24 hours". The VAS is a simple-to-use assessment tool that does not require sophisticated equipment. It is also highly sensitive in detecting the effects of treatment, and its results can be analyzed using parametric tests. In this study, a plastic band was made for all patients,
Pain assessment
Time frame: Immediately After anesthesia
It will be carried out as follows: the healthcare professional asks the patient to select a point on a line 10cm long, drawn between two extremities to express the intensity of the pain. Patients will be asked to rate "current" pain intensity or, in other cases, pain intensity "in the last 24 hours". The VAS is a simple-to-use assessment tool that does not require sophisticated equipment. It is also highly sensitive in detecting the effects of treatment, and its results can be analyzed using parametric tests. In this study, a plastic band was made for all patients,
16 secondary outcomes
Anxiety assessment using Beck's questionnaire
Time frame: Immediately Before anesthesia
Anxiety assessment using Beck's questionnaire
Time frame: Immediately After anesthesia
Latency time
Time frame: Immediately Before anesthesia
Latency time
Time frame: 2 minutes after anesthesia
Latency time
Time frame: 5 minutes after anesthesia
Latency time
Time frame: 10 minutes after anesthesia
Latency time
Time frame: 15 minutes after anesthesia
Latency time
Time frame: 20 minutes after anesthesia
Latency time
Time frame: 25 minutes after anesthesia
Latency time
Time frame: 30 minutes after anesthesia
Assessment of blood pressure
Time frame: Immediately Before anesthesia
Assessment of blood pressure
Time frame: 10 minutes after anesthesia
Blood oxygen saturation level
Time frame: Immediately Before anesthesia
Blood oxygen saturation level
Time frame: 10 minutes after anesthesia
Pterygomandibular technique success rate
Time frame: Immediately After procedure
Suplementar anesthesia
Time frame: Immediately after procedure
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 18 Jul 2024.
- Derived from this study: PubMed 39400883Ferreira GF, Machado GGA, Roncolato VL, Ramalho KM, Motta LJ, Bussadori SK, Duran CCG, Fernandes KPS, Mesquita Ferrari RA, Chiniforush N, Horliana ACRT. Photobiomodulation therapy on puncture-associated pain: A controlled randomized double-blind clinical trial. Photochem Photobiol. 2025 May-Jun;101(3):771-781. doi: 10.1111/php.14027. Epub 2024 Oct 14.
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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.
Anna Carolina Horliana, PhD study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation, Mepivacaine hydrochloride in combination with epinephrine and Photobiomodulation simulation in people with Fear Needles, run by University of Nove de Julho at 1 site in Brazil.
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 7 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 18 Jul 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 Brazil. 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?
Pain assessment (time frame: Immediately Before anesthesia). 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 NCT06128590, 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 18 Jul 2024.