Dental AnxietyIANBNCT07667725
Reducing Pain During Dental Nerve Block Injections in Children
A study testing Buzzy Device, Counterstimulation and 30-Gauge Needle in people with Dental Anxiety and Inferior Alveolar Nerve, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
Title of Study: Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients Why was this study done? The inferior alveolar nerve block (IANB) is a dental injection used to numb the lower jaw and… Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Inferior Alveolar Nerve, Pain Management
- What is being tested?
- Buzzy Device, Counterstimulation and 30-Gauge Needle
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2025to 30 Sep 2025
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5 to 9 years. Requiring dental procedures under inferior alveolar nerve block (IANB) anesthesia.
- Medically healthy children classified as American Society of Anesthesiologists (ASA) Class I or II.
- Baseline Frankl Behavior Rating of 2 or 3 (indicating cooperative or potentially cooperative behavior).
- Written informed consent obtained from parents or legal guardians. Age-appropriate assent obtained from the child. -
Who cannot join
- Presence of systemic illness.
- Neurological disorders.
- Developmental conditions affecting pain perception.
- Previous traumatic dental injection experiences.
- Allergy or hypersensitivity to lidocaine with epinephrine.
- Significant respiratory or cardiovascular conditions (to avoid confounding physiological monitoring).
- Children who exhibit excessive distress during the procedure will be withdrawn and treated per standard care (this can be added as a withdrawal criterion if needed).
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients
Title of Study: Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients
Why was this study done? The inferior alveolar nerve block (IANB) is a dental injection used to numb the lower jaw and teeth in children. Many children find this injection very painful and scary. Bad experiences can make them afraid of the dentist for years. This study was designed to test different ways to make the injection less painful and stressful for children.
Read more
What did the researchers want to find out?
They planned to compare three different methods to see which one works best to reduce pain, distress, and physical signs of fear (like a fast heartbeat) during the injection:
External cooling + vibration (using a special device that cools and vibrates on the skin near the injection site)
Counterstimulation (gentle tapping or pressing with a cotton roll near the injection site)
A thinner needle (30-gauge instead of the standard 27-gauge)
Standard method (27-gauge needle with no extra distraction) - this is the control group
Who took part? The study enrolled 166 healthy children between the ages of 5 and 9 years who needed a lower jaw dental injection at Al-Mustansiriyah University Dental College.
What happened during the study?
Children were randomly placed into one of the four groups. All children received the same numbing medicine (2% lidocaine with epinephrine). Dentists gave the injection at the same speed for everyone. Researchers planned to measure:
How much pain the child felt (using the Wong-Baker Faces scale, where children point to a face showing their pain level)
How much pain the child showed (using the FLACC scale, which looks at face, legs, activity, crying, and comfort)
Heart rate and oxygen level (using a finger clip device)
How well the child cooperated (using the Frankl Behavior Rating Scale)
What outcomes are being measured? The primary outcomes are children's self-reported pain and observer-rated pain behavior. Secondary outcomes include physiological responses (heart rate and oxygen saturation) and behavioral cooperation scores. The study will compare changes in these measures across the four intervention groups.
What is the purpose of this research? The findings from this trial are expected to provide evidence to help dentists choose the most effective comfort measures to keep children calm and pain-free during lower jaw injections. The study aims to clarify whether distraction-based methods (cooling+vibration or counterstimulation) offer advantages over simply changing the needle gauge.
Were there any side effects or risks? Safety is being monitored continuously throughout the procedure via pulse oximetry (oxygen saturation) and heart rate tracking. The interventions are considered low-risk, and children who show excessive distress are withdrawn and managed according to standard care.
Who paid for this study? The study received no outside funding. The authors declared no conflicts of interest.
Where was the study done? Department of Pediatric Dentistry, Al-Mustansiriyah University, Baghdad, Iraq.
Read the detailed description
Study Design This is a prospective, parallel-group, randomized controlled clinical trial (RCT) conducted at the Department of Pediatric Dentistry, Al-Mustansiriyah University College of Dentistry, Baghdad, Iraq. The trial is designed to compare the effectiveness of three interventions versus a standard control in reducing pain, physiological stress, and behavioral distress during inferior alveolar nerve block (IANB) in pediatric dental patients.
Participants A total of 166 medically healthy children (ASA I or II) aged 5 to 9 years, who required dental treatment under IANB, were enrolled. Inclusion criteria included a baseline Frankl Behavior Rating of 2 or 3 (cooperative or potentially cooperative). Exclusion criteria were systemic illness, neurological or developmental conditions affecting pain perception, previous traumatic dental injection experience, allergy to lidocaine or epinephrine, and significant respiratory or cardiovascular conditions.
Randomization and Allocation Children were randomly assigned to one of four groups using a sealed-envelope method to ensure allocation concealment. Group sizes: Cooling + Vibration (n=40), Counterstimulation (n=41), 30-gauge needle (n=43), and standard 27-gauge needle control (n=42).
Interventions All injections use 2% lidocaine with 1:100,000 epinephrine, administered at a controlled rate of 1 mL/min by calibrated pediatric dentists.
Cooling + Vibration group: A thermomechanical device (Buzzy®, MMJ Labs, USA) is applied externally to the injection site for 30-60 seconds before needle insertion and remains in place during anesthetic deposition. The device provides simultaneous cooling and vibration.
Counterstimulation group: Gentle manual tapping or pressure with a cotton roll is applied adjacent to the injection site throughout the procedure.
30-gauge needle group: IANB is performed using a long 30-gauge needle without any distraction technique.
Standard control group (27-gauge needle): Routine IANB using a long 27-gauge needle, representing standard clinical practice.
Outcome Measures
Primary outcomes:
Child self-reported pain using the Wong-Baker FACES Pain Rating Scale (0-10) immediately post-injection.
Observer-rated pain behavior using the FLACC scale (Face, Legs, Activity, Cry, Consolability; 0-10) during the injection.
Secondary outcomes:
Heart rate (beats per minute) and oxygen saturation (%) continuously recorded via pediatric pulse oximetry.
Behavioral cooperation assessed with the Frankl Behavior Rating Scale (1-4).
All outcome assessments are performed by a blinded, calibrated observer. Children provide self-reported pain scores immediately after the injection using age-appropriate instructions.
Statistical Analysis Descriptive statistics will summarize baseline characteristics. Paired t-tests will compare within-group changes from baseline to follow-up. One-way analysis of variance (ANOVA) with Bonferroni post-hoc corrections will be used for between-group comparisons. The level of statistical significance is set at p < 0.05. Analyses will be performed using IBM SPSS version 28.
Ethical Approval The study protocol was approved by the Institutional Review Board of Al-Mustansiriyah University College of Dentistry (clinical trial number: MUPEDO4, REC199). Written informed consent was obtained from parents or legal guardians, and assent was obtained from children. The study complies with the Declaration of Helsinki (2013). Children who become excessively distressed are withdrawn and managed according to standard care.
Trial Registration (If applicable, the registry number and date would be entered here; the document lists an internal number MUPEDO4, REC199.
- Conditions
- Dental Anxiety, Inferior Alveolar Nerve, Pain Management
- Being tested
- Buzzy Device, Counterstimulation, 30-Gauge Needle, 27-Gauge Needle, Lidocaine hydrochloride 2% with epinephrine 1:100 000
- Keywords
- inferior alveolar nerve block, pain management, cooling and vibration, Pediatric dentistry, needle gauge
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy DeviceDevice
A thermomechanical device providing simultaneous vibration and cooling, placed externally at the injection site for 30-60 seconds before and during local anesthetic deposition.
CounterstimulationProcedure or surgery
Gentle manual tapping and pressure applied with a cotton roll adjacent to the injection site throughout the injection to provide tactile distraction.
30-Gauge NeedleDevice
A 30-gauge long dental needle used for the inferior alveolar nerve block.
27-Gauge NeedleDevice
A 27-gauge long dental needle used for the inferior alveolar nerve block (standard control).
Lidocaine hydrochloride 2% with epinephrine 1:100 000Drug
2% lidocaine with 1:100,000 epinephrine administered as a local anesthetic for the inferior alveolar nerve block at 1 mL/min.
| Study group | Role | What they receive |
|---|---|---|
| Cooling + Vibration | Experimental | A thermomechanical device (Buzzy™, MMJ Labs, USA) is positioned externally at the injection site for 30-60 seconds before needle insertion and remains in place during anesthetic deposition, providing simultaneous vibration and cooling. The inferior alveolar nerve block (IANB) is performed using 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. Receives: Device: Buzzy Device; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 |
| Counterstimulation | Experimental | Gentle manual tapping and pressure with a cotton roll adjacent to the injection site is applied throughout the injection to provide non-noxious tactile input and attentional distraction. The IANB is performed using 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. Receives: Procedure: Counterstimulation; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 |
| 30-Gauge Needle | Experimental | A standard IANB is performed using a 30-gauge long needle without additional distraction techniques. The anesthetic used is 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. Receives: Device: 30-Gauge Needle; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 |
| Standard 27G Needle (Control) | Active comparator | A routine IANB is performed using a standard 27-gauge long needle as the control condition. The anesthetic used is 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. This represents the current standard of care. Receives: Device: 27-Gauge Needle; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale
Description: Self-reported pain intensity assessed by the child immediately after the inferior alveolar nerve block (IANB) injection. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." Children select the face that best matches their pain experience.
Measured: Time Frame: Immediately post-procedure
FLACC Scale (Face, Legs, Activity, Cry, Consolability)
Description: Observer-rated behavioral pain assessment scored by a blinded, calibrated observer during the injection procedure. The scale evaluates five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored 0-2, for a total score ranging from 0 to 10. Higher scores indicate greater pain and distress.
Measured: Periprocedural
Secondary outcomes (3)
Heart Rate (bpm)
Description: Assessed continuously during injection via pulse oximetry.
Measured: Periprocedural
Oxygen Saturation
Assessed continuously during injection via pulse oximetry
Measured: Periprocedural
Frankl Behavior Rating Scale
Observer-rated behavioral cooperation assessed during the procedure.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Feb 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Fadhil Mohamed-Ali, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667725
- Sponsor's protocol ID
- MUPEDO4
- Acronym
- IANB
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study involves a vulnerable pediatric population (children aged 5-9 years). Informed consent obtained from parents/guardians did not include provisions for sharing de-identified data with external researchers. Additionally, institutional policies at Al-Mustansiriyah University restrict the sharing of pediatric health data to protect patient privacy and confidentiality. No data-sharing agreement or repository has been established for this single-center trial.
Publications
Eleraky RH, Mohy ElDin M, Ibrahim Y, Soliman RS, Wahba NA. Effect of needle bevel type on pain perception in children during inferior alveolar nerve block anesthesia: randomized controlled clinical trial. BMC Oral Health. 2025 Sep 2;25(1):1400. doi: 10.1186/s12903-025-06731-7.
PubMed 40898243Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.
PubMed 30908775Turan Y, Senirkentli GB, Cekmen N, Tirali E, Cakmak E. Retrospective Evaluation of the Effects of Local Anesthesia Before Tooth Extraction Procedures under General Anesthesia on Physiologic Parameters and Postoperative Bleeding in Children. Niger J Clin Pract. 2024 Jun 1;27(6):723-731. doi: 10.4103/njcp.njcp_708_23. Epub 2024 Jun 29.
PubMed 38943296Roberts JF, Curzon ME, Koch G, Martens LC. Review: behaviour management techniques in paediatric dentistry. Eur Arch Paediatr Dent. 2010 Aug;11(4):166-74. doi: 10.1007/BF03262738.
PubMed 20840826
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07667725
- Acronym / sponsor ID
- IANB / MUPEDO4
- Conditions
- Dental Anxiety, Inferior Alveolar Nerve, Pain Management
- Keywords
- inferior alveolar nerve block, pain management, cooling and vibration, Pediatric dentistry, needle gauge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 25 Jun 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.
Title of Study: Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients
Why was this study done? The inferior alveolar nerve block (IANB) is a dental injection used to numb the lower jaw and teeth in children. Many children find this injection very painful and scary. Bad experiences can make them afraid of the dentist for years. This study was designed to test different ways to make the injection less painful and stressful for children.
What did the researchers want to find out?
They planned to compare three different methods to see which one works best to reduce pain, distress, and physical signs of fear (like a fast heartbeat) during the injection:
External cooling + vibration (using a special device that cools and vibrates on the skin near the injection site)
Counterstimulation (gentle tapping or pressing with a cotton roll near the injection site)
A thinner needle (30-gauge instead of the standard 27-gauge)
Standard method (27-gauge needle with no extra distraction) - this is the control group
Who took part? The study enrolled 166 healthy children between the ages of 5 and 9 years who needed a lower jaw dental injection at Al-Mustansiriyah University Dental College.
What happened during the study?
Children were randomly placed into one of the four groups. All children received the same numbing medicine (2% lidocaine with epinephrine). Dentists gave the injection at the same speed for everyone. Researchers planned to measure:
How much pain the child felt (using the Wong-Baker Faces scale, where children point to a face showing their pain level)
How much pain the child showed (using the FLACC scale, which looks at face, legs, activity, crying, and comfort)
Heart rate and oxygen level (using a finger clip device)
How well the child cooperated (using the Frankl Behavior Rating Scale)
What outcomes are being measured? The primary outcomes are children's self-reported pain and observer-rated pain behavior. Secondary outcomes include physiological responses (heart rate and oxygen saturation) and behavioral cooperation scores. The study will compare changes in these measures across the four intervention groups.
What is the purpose of this research? The findings from this trial are expected to provide evidence to help dentists choose the most effective comfort measures to keep children calm and pain-free during lower jaw injections. The study aims to clarify whether distraction-based methods (cooling+vibration or counterstimulation) offer advantages over simply changing the needle gauge.
Were there any side effects or risks? Safety is being monitored continuously throughout the procedure via pulse oximetry (oxygen saturation) and heart rate tracking. The interventions are considered low-risk, and children who show excessive distress are withdrawn and managed according to standard care.
Who paid for this study? The study received no outside funding. The authors declared no conflicts of interest.
Where was the study done? Department of Pediatric Dentistry, Al-Mustansiriyah University, Baghdad, Iraq.
Detailed description
Study Design This is a prospective, parallel-group, randomized controlled clinical trial (RCT) conducted at the Department of Pediatric Dentistry, Al-Mustansiriyah University College of Dentistry, Baghdad, Iraq. The trial is designed to compare the effectiveness of three interventions versus a standard control in reducing pain, physiological stress, and behavioral distress during inferior alveolar nerve block (IANB) in pediatric dental patients.
Participants A total of 166 medically healthy children (ASA I or II) aged 5 to 9 years, who required dental treatment under IANB, were enrolled. Inclusion criteria included a baseline Frankl Behavior Rating of 2 or 3 (cooperative or potentially cooperative). Exclusion criteria were systemic illness, neurological or developmental conditions affecting pain perception, previous traumatic dental injection experience, allergy to lidocaine or epinephrine, and significant respiratory or cardiovascular conditions.
Randomization and Allocation Children were randomly assigned to one of four groups using a sealed-envelope method to ensure allocation concealment. Group sizes: Cooling + Vibration (n=40), Counterstimulation (n=41), 30-gauge needle (n=43), and standard 27-gauge needle control (n=42).
Interventions All injections use 2% lidocaine with 1:100,000 epinephrine, administered at a controlled rate of 1 mL/min by calibrated pediatric dentists.
Cooling + Vibration group: A thermomechanical device (Buzzy®, MMJ Labs, USA) is applied externally to the injection site for 30-60 seconds before needle insertion and remains in place during anesthetic deposition. The device provides simultaneous cooling and vibration.
Counterstimulation group: Gentle manual tapping or pressure with a cotton roll is applied adjacent to the injection site throughout the procedure.
30-gauge needle group: IANB is performed using a long 30-gauge needle without any distraction technique.
Standard control group (27-gauge needle): Routine IANB using a long 27-gauge needle, representing standard clinical practice.
Outcome Measures
Primary outcomes:
Child self-reported pain using the Wong-Baker FACES Pain Rating Scale (0-10) immediately post-injection.
Observer-rated pain behavior using the FLACC scale (Face, Legs, Activity, Cry, Consolability; 0-10) during the injection.
Secondary outcomes:
Heart rate (beats per minute) and oxygen saturation (%) continuously recorded via pediatric pulse oximetry.
Behavioral cooperation assessed with the Frankl Behavior Rating Scale (1-4).
All outcome assessments are performed by a blinded, calibrated observer. Children provide self-reported pain scores immediately after the injection using age-appropriate instructions.
Statistical Analysis Descriptive statistics will summarize baseline characteristics. Paired t-tests will compare within-group changes from baseline to follow-up. One-way analysis of variance (ANOVA) with Bonferroni post-hoc corrections will be used for between-group comparisons. The level of statistical significance is set at p < 0.05. Analyses will be performed using IBM SPSS version 28.
Ethical Approval The study protocol was approved by the Institutional Review Board of Al-Mustansiriyah University College of Dentistry (clinical trial number: MUPEDO4, REC199). Written informed consent was obtained from parents or legal guardians, and assent was obtained from children. The study complies with the Declaration of Helsinki (2013). Children who become excessively distressed are withdrawn and managed according to standard care.
Trial Registration (If applicable, the registry number and date would be entered here; the document lists an internal number MUPEDO4, REC199.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cooling + Vibration | Experimental | Device: Buzzy Device, Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000A thermomechanical device (Buzzy™, MMJ Labs, USA) is positioned externally at the injection site for 30-60 seconds before needle insertion and remains in place during anesthetic deposition, providing simultaneous vibration and cooling. The inferior alveolar nerve block (IANB) is performed using 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. |
| Counterstimulation | Experimental | Procedure: Counterstimulation, Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000Gentle manual tapping and pressure with a cotton roll adjacent to the injection site is applied throughout the injection to provide non-noxious tactile input and attentional distraction. The IANB is performed using 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. |
| 30-Gauge Needle | Experimental | Device: 30-Gauge Needle, Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000A standard IANB is performed using a 30-gauge long needle without additional distraction techniques. The anesthetic used is 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. |
| Standard 27G Needle (Control) | Active comparator | Device: 27-Gauge Needle, Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000A routine IANB is performed using a standard 27-gauge long needle as the control condition. The anesthetic used is 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. This represents the current standard of care. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 5 to 9 years. Requiring dental procedures under inferior alveolar nerve block (IANB) anesthesia.
- Medically healthy children classified as American Society of Anesthesiologists (ASA) Class I or II.
- Baseline Frankl Behavior Rating of 2 or 3 (indicating cooperative or potentially cooperative behavior).
- Written informed consent obtained from parents or legal guardians. Age-appropriate assent obtained from the child. -
Key exclusion criteria (8 listed)
- Presence of systemic illness.
- Neurological disorders.
- Developmental conditions affecting pain perception.
- Previous traumatic dental injection experiences.
- Allergy or hypersensitivity to lidocaine with epinephrine.
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 |
|---|---|---|
| Buzzy DeviceA thermomechanical device providing simultaneous vibration and cooling, placed externally at the injection site for 30-60 seconds before and during local anesthetic deposition. | Device | Cooling + Vibration |
| CounterstimulationGentle manual tapping and pressure applied with a cotton roll adjacent to the injection site throughout the injection to provide tactile distraction. | Procedure or surgery | Counterstimulation |
| 30-Gauge NeedleA 30-gauge long dental needle used for the inferior alveolar nerve block. | Device | 30-Gauge Needle |
| 27-Gauge NeedleA 27-gauge long dental needle used for the inferior alveolar nerve block (standard control). | Device | Standard 27G Needle (Control) |
| Lidocaine hydrochloride 2% with epinephrine 1:100 0002% lidocaine with 1:100,000 epinephrine administered as a local anesthetic for the inferior alveolar nerve block at 1 mL/min. | Drug | 30-Gauge Needle, Cooling + Vibration, Counterstimulation, Standard 27G Needle (Control) |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: Time Frame: Immediately post-procedure
Description: Self-reported pain intensity assessed by the child immediately after the inferior alveolar nerve block (IANB) injection. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." Children select the face that best matches their pain experience.
FLACC Scale (Face, Legs, Activity, Cry, Consolability)
Time frame: Periprocedural
Description: Observer-rated behavioral pain assessment scored by a blinded, calibrated observer during the injection procedure. The scale evaluates five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored 0-2, for a total score ranging from 0 to 10. Higher scores indicate greater pain and distress.
3 secondary outcomes
Heart Rate (bpm)
Time frame: Periprocedural
Oxygen Saturation
Time frame: Periprocedural
Frankl Behavior Rating Scale
Time frame: Periprocedural
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 Jun 2026.
- Background: PubMed 40898243Eleraky RH, Mohy ElDin M, Ibrahim Y, Soliman RS, Wahba NA. Effect of needle bevel type on pain perception in children during inferior alveolar nerve block anesthesia: randomized controlled clinical trial. BMC Oral Health. 2025 Sep 2;25(1):1400. doi: 10.1186/s12903-025-06731-7.
- Background: PubMed 30908775Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.
- Background: PubMed 38943296Turan Y, Senirkentli GB, Cekmen N, Tirali E, Cakmak E. Retrospective Evaluation of the Effects of Local Anesthesia Before Tooth Extraction Procedures under General Anesthesia on Physiologic Parameters and Postoperative Bleeding in Children. Niger J Clin Pract. 2024 Jun 1;27(6):723-731. doi: 10.4103/njcp.njcp_708_23. Epub 2024 Jun 29.
- Results publication: PubMed 20840826Roberts JF, Curzon ME, Koch G, Martens LC. Review: behaviour management techniques in paediatric dentistry. Eur Arch Paediatr Dent. 2010 Aug;11(4):166-74. doi: 10.1007/BF03262738.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study involves a vulnerable pediatric population (children aged 5-9 years). Informed consent obtained from parents/guardians did not include provisions for sharing de-identified data with external researchers. Additionally, institutional policies at Al-Mustansiriyah University restrict the sharing of pediatric health data to protect patient privacy and confidentiality. No data-sharing agreement or repository has been established for this single-center trial.
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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 Buzzy Device, Counterstimulation and 30-Gauge Needle in people with Dental Anxiety and Inferior Alveolar Nerve, run by Al-Mustansiriyah University at 1 site in Iraq.
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 8 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 Jun 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 Iraq. 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?
Wong-Baker FACES Pain Rating Scale (time frame: Time Frame: Immediately post-procedure). 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 NCT07667725, which also lists 4 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 Jun 2026.