Local Anesthetic InfiltrationPhase 3No acronymNCT07351383
Topical Cryoanesthesia Versus Benzocaine in Pediatric Dentistry
A Phase 3 study testing Local Anesthesia (lidocaine hydrochloride) in people with Local Anesthetic Infiltration and Topical Anesthesia, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
This clinical study tested and compared two ways (cold-base technique or "cryoanesthesia" and conventional benzocaine gel) to reduce pain from dental injections in children. Researchers worked with 28 children between 6 and 12 years old who needed injections on both sides of the lower jaw for dental treatment. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthetic Infiltration, Topical Anesthesia, Pain Perception
- What is being tested?
- Local Anesthesia (lidocaine hydrochloride)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jun 2025to 25 Nov 2025
- Phase
- Phase 3
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Systemic health: No significant medical history or uncontrolled systemic disease.
- Bilateral dental pathology requiring treatment: At least two teeth (one per mandibular hemiarch) requiring bilateral inferior alveolar nerve blocks for restorative or endodontic treatment.
- Cooperation level: Frankl behavioral rating scale classification III or IV (positive or very positive).
- Informed consent/Child assent: Signed informed consent from parent or legal guardian; signed assent from participant (age-appropriate).
Who cannot join
- Acute dental emergency requiring immediate treatment.
- Known hypersensitivity or allergy to benzocaine or other local anesthetics.
- Known hypersensitivity to cold (cryophobia or cold urticaria).
- Significant dental anxiety or phobia precluding study participation.
- Developmental delay or behavioral disorders limiting communication or cooperation.
- Current use of medications affecting pain perception or hemodynamic parameters.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Pediatric Dentistry Postgraduate Program, Faculty of Denttistry
San Luis Potosí City, S.l.p., 78990
About this study
Official title: Comparison of Topical Cryoanethesia and Benzocaine in Pain Perception During Mandibular Nerve Block in Pediatric Patients: A Randomized Controlled Clinical Trial
This clinical study tested and compared two ways (cold-base technique or "cryoanesthesia" and conventional benzocaine gel) to reduce pain from dental injections in children.
Researchers worked with 28 children between 6 and 12 years old who needed injections on both sides of the lower jaw for dental treatment. Each child received cryoanesthesia on one side and 20% benzocaine gel on the other side, in different appointments, and the team measured pain, behavior, heart rate, and blood oxygen levels.
Read the detailed description
Objective: To evaluate and compare pain perception during inferior alveolar nerve block puncture in pediatric patients using cryoanesthesia versus conventional topical benzocaine anesthesia.
Methods: A split-mouth randomized controlled clinical trial was conducted with 28 patients aged 6 to 12 years requiring bilateral inferior alveolar nerve blocks for bilateral lower arch dental treatment. Each participant received both anesthetic techniques in a randomized order on separate appointments, with treatment allocated to contralateral mandibular hemiarches. Primary and secondary outcome measures included pain intensity (Visual Analog Scale), heart rate, oxygen saturation, and behavioral response (FLACC scale).
- Being tested
- Local Anesthesia (lidocaine hydrochloride)
- Keywords
- Topical dental anesthesia, Children, Anesthesia punction, Pain perception, Cryoanesthesia, Benzocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthesia (lidocaine hydrochloride)Procedure or surgery
After topical anesthesia (either technique), the clinician proceeded with conventional inferior alveolar nerve block using standardized technique:
- Patient positioned recumbent in dental chair with mouth held open.
- Palpation of ipsilateral mandibular condyle by clinician's non-dominant hand.
- Cheek retracted with non-dominant hand to improve visualization.
- Long needle (27-gauge, 32 mm) inserted at horizontal level of contralateral mandibular canine, directed toward insertion of lateral pterygoid muscle below maxillary tuberosity.
- Needle advanced to contact medial mandibular wall (lingual surface).
- Aspiration performed to rule out intravascular needle placement.
- Injection of local anesthetic solution (1.8 mL of 2% lidocaine with 1:100,000 epinephrine).
- Needle carefully withdrawn following injection completion.
Local Anesthesia (lidocaine hydrochloride)Procedure or surgery
After topical anesthesia (either technique), the clinician proceeded with conventional inferior alveolar nerve block using standardized technique:
- Patient positioned recumbent in dental chair with mouth held open
- Palpation of ipsilateral mandibular condyle by clinician's non-dominant hand
- Cheek retracted with non-dominant hand to improve visualization
- Long needle (27-gauge, 32 mm) inserted at horizontal level of contralateral mandibular canine, directed toward insertion of lateral pterygoid muscle below maxillary tuberosity
- Needle advanced to contact medial mandibular wall (lingual surface)
- Aspiration performed to rule out intravascular needle placement
- Injection of local anesthetic solution (1.8 mL of 2% lidocaine with 1:100,000 epinephrine)
- Needle carefully withdrawn following injection completion
| Study group | Role | What they receive |
|---|---|---|
| Cryanesthesia. Topical anesthesia using application of ice cones, before anesthesic punction. | Experimental | Ice cones were prepared using sterile, individual-sized latex gloves filled with purified, sterile water. The open end of each glove was sealed and the glove was placed in a freezer (temperature: -18°C to -20°C) for minimum 24 hours prior to use. This produced a textured ice cone of approximately 5 cm × 3 cm suitable for direct application to the infiltration site.
1. The application site (infiltration area on mucous membrane) was gently dried with sterile gauze.
2. The ice cone was applied directly to the area using gentle circular rubbing motions.
3. Duration of application: 60 seconds.
4. Assessment: Observation for tissue blanching (white appearance) indicating adequate cooling. Receives: Procedure: Local Anesthesia (lidocaine hydrochloride) |
| Benzocaine group: Topical anesthesia using 20% benzocaine, before anesthetic punction. | Active comparator | Benzocaine 20% Topical Anesthesia Technique:
1. The application site was gently dried with sterile gauze
2. Benzocaine 20% topical solution was applied using a sterile cotton applicator via gentle rubbing of the infiltration site
3. Duration of application: 60 seconds
4. No mechanical removal was performed; anesthetic was allowed to remain on tissue Receives: Procedure: Local Anesthesia (lidocaine hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
Pain intensity was assessed using a validated instrument:
Wong-Baker FACES® Pain Rating Scale (Visual Analog Scale): Immediately following completion of infiltration anesthesia injection, the participant was asked to indicate the level of pain experienced using the face scale (0 = no hurt to 10 = hurts worst).
Measured: Baseline: At the time of the anesthetic injection (or needle puncture) at the oral mucosa.
Secondary outcomes (3)
Heart Rate
Continuous pulse oximetry monitoring was conducted using a calibrated pulse oximeter (typical brands: Nellcor or equivalent) with appropriate pediatric finger probe or reusable sensor. Measurement unit: Pulses per minute (ppm) for heart rate (HR), which were recorded at two time points:
- Baseline measurement: Immediately before topical anesthetic application, with the participant in a calm resting state.
- During anesthetic infiltration: Recorded during active injection of local anesthetic solution into the infiltration site (oral mucosa).
Measured: Periprocedural: During the injection anesthetic procedure, from the anesthetic solution injection to the removal of the needle (approximately 45 seconds)
Oxygen saturation
Percentage of blood's hemoglobin carrying oxygen (normally 95-100%). Continuous pulse oximetry monitoring was conducted using a calibrated pulse oximeter (typical brands: Nellcor or equivalent) with appropriate pediatric finger probe or reusable sensor. Measurement units: SpO2 percentage (%), which was recorded at two time points: 1. Baseline measurement: Immediately before topical anesthetic application, with the participant in a calm resting state. And 2. During infiltration measurement: During active injection of local anesthetic solution into the infiltration site.
Measured: Periprocedural: During the injection anesthetic procedure, from the needle puncture to the removal of the needle (approximately 45 seconds).
Patient's behavioral response
Observable emotional and physiological reactions to the anesthetic injection through the FLACC (Facial expression, Legs, Activity, Cry, and Consolability) scale. Values: 0-10 (0 = relaxed, calm; 10 = severe distress).
Measured: Periprocedural: 45 seconds, from the anesthetic injection to the removal of the needle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Jun 2025
- Primary completion10 Oct 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Local Anesthetic InfiltrationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A split-mouth randomized controlled clinical trial was conducted with 28 patients aged 6 to 12 years requiring bilateral inferior alveolar nerve blocks for bilateral lower arch dental treatment. Each participant received both anesthetic techniques in a randomized order on separate appointments, with treatment allocated to contralateral mandibular hemiarches. Primary and secondary outcome measures included pain intensity (Visual Analog Scale), heart rate, oxygen saturation, and behavioral response (FLACC scale).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Arturo Garrocho Rangel, Universidad Autonoma de San Luis Potosí
- Investigators
- Amaury Pozos Guillén, Ph.D., Study director, Universidad Autónoma de San Luis Potosi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351383
- Sponsor's protocol ID
- U.A.S.L.P.
- Other IDs
- No funding
- Acronym
- No acronym
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ninawe N, Anija CK. Comparative Evaluation of Effectiveness of Benzocaine Gel and Ice for Pain Management in Children during Local Anesthetic Administration by CCLAD: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Jan;18(1):19-23. doi: 10.5005/jp-journals-10005-3045. Epub 2025 Feb 14.
PubMed 40110448Tirupathi SP, Rajasekhar S. Effect of precooling on pain during local anesthesia administration in children: a systematic review. J Dent Anesth Pain Med. 2020 Jun;20(3):119-127. doi: 10.17245/jdapm.2020.20.3.119. Epub 2020 Jun 24.
PubMed 32617406Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
PubMed 26379379
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Cryoanethesia and Benzocaine in Pain Perception During Mandibular Nerve Block in Pediatric Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07351383
- Acronym / sponsor ID
- No acronym / U.A.S.L.P.
- Keywords
- Topical dental anesthesia, Children, Anesthesia punction, Pain perception, Cryoanesthesia, Benzocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study tested and compared two ways (cold-base technique or "cryoanesthesia" and conventional benzocaine gel) to reduce pain from dental injections in children.
Researchers worked with 28 children between 6 and 12 years old who needed injections on both sides of the lower jaw for dental treatment. Each child received cryoanesthesia on one side and 20% benzocaine gel on the other side, in different appointments, and the team measured pain, behavior, heart rate, and blood oxygen levels.
Detailed description
Objective: To evaluate and compare pain perception during inferior alveolar nerve block puncture in pediatric patients using cryoanesthesia versus conventional topical benzocaine anesthesia.
Methods: A split-mouth randomized controlled clinical trial was conducted with 28 patients aged 6 to 12 years requiring bilateral inferior alveolar nerve blocks for bilateral lower arch dental treatment. Each participant received both anesthetic techniques in a randomized order on separate appointments, with treatment allocated to contralateral mandibular hemiarches. Primary and secondary outcome measures included pain intensity (Visual Analog Scale), heart rate, oxygen saturation, and behavioral response (FLACC scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A split-mouth randomized controlled clinical trial was conducted with 28 patients aged 6 to 12 years requiring bilateral inferior alveolar nerve blocks for bilateral lower arch dental treatment. Each participant received both anesthetic techniques in a randomized order on separate appointments, with treatment allocated to contralateral mandibular hemiarches. Primary and secondary outcome measures included pain intensity (Visual Analog Scale), heart rate, oxygen saturation, and behavioral response (FLACC scale).
| Arm | Type | Receives |
|---|---|---|
| Cryanesthesia. Topical anesthesia using application of ice cones, before anesthesic punction. | Experimental | Procedure: Local Anesthesia (lidocaine hydrochloride)Ice cones were prepared using sterile, individual-sized latex gloves filled with purified, sterile water. The open end of each glove was sealed and the glove was placed in a freezer (temperature: -18°C to -20°C) for minimum 24 hours prior to use. This produced a textured ice cone of approximately 5 cm × 3 cm suitable for direct application to the infiltration site. 1. The application site (infiltration area on mucous membrane) was gently dried with sterile gauze. 2. The ice cone was applied directly to the area using gentle circular rubbing motions. 3. Duration of application: 60 seconds. 4. Assessment: Observation for tissue blanching (white appearance) indicating adequate cooling. |
| Benzocaine group: Topical anesthesia using 20% benzocaine, before anesthetic punction. | Active comparator | Procedure: Local Anesthesia (lidocaine hydrochloride)Benzocaine 20% Topical Anesthesia Technique: 1. The application site was gently dried with sterile gauze 2. Benzocaine 20% topical solution was applied using a sterile cotton applicator via gentle rubbing of the infiltration site 3. Duration of application: 60 seconds 4. No mechanical removal was performed; anesthetic was allowed to remain on tissue |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Systemic health: No significant medical history or uncontrolled systemic disease.
- Bilateral dental pathology requiring treatment: At least two teeth (one per mandibular hemiarch) requiring bilateral inferior alveolar nerve blocks for restorative or endodontic treatment.
- Cooperation level: Frankl behavioral rating scale classification III or IV (positive or very positive).
- Informed consent/Child assent: Signed informed consent from parent or legal guardian; signed assent from participant (age-appropriate).
Key exclusion criteria (6 listed)
- Acute dental emergency requiring immediate treatment.
- Known hypersensitivity or allergy to benzocaine or other local anesthetics.
- Known hypersensitivity to cold (cryophobia or cold urticaria).
- Significant dental anxiety or phobia precluding study participation.
- Developmental delay or behavioral disorders limiting communication or cooperation.
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 |
|---|---|---|
| Local Anesthesia (lidocaine hydrochloride)After topical anesthesia (either technique), the clinician proceeded with conventional inferior alveolar nerve block using standardized technique: 1. Patient positioned recumbent in dental chair with mouth held open. 2. Palpation of ipsilateral mandibular condyle by clinician's non-dominant hand. 3. Cheek retracted with non-dominant hand to improve visualization. 4. Long needle (27-gauge, 32 mm) inserted at horizontal level of contralateral mandibular canine, directed toward insertion of lateral pterygoid muscle below maxillary tuberosity. 5. Needle advanced to contact medial mandibular wall (lingual surface). 6. Aspiration performed to rule out intravascular needle placement. 7. Injection of local anesthetic solution (1.8 mL of 2% lidocaine with 1:100,000 epinephrine). 8. Needle carefully withdrawn following injection completion. | Procedure or surgery | Benzocaine group: Topical anesthesia using 20% benzocaine, before anesthetic punction., Cryanesthesia. Topical anesthesia using application of ice cones, before anesthesic punction. |
| Local Anesthesia (lidocaine hydrochloride)After topical anesthesia (either technique), the clinician proceeded with conventional inferior alveolar nerve block using standardized technique: 1. Patient positioned recumbent in dental chair with mouth held open 2. Palpation of ipsilateral mandibular condyle by clinician's non-dominant hand 3. Cheek retracted with non-dominant hand to improve visualization 4. Long needle (27-gauge, 32 mm) inserted at horizontal level of contralateral mandibular canine, directed toward insertion of lateral pterygoid muscle below maxillary tuberosity 5. Needle advanced to contact medial mandibular wall (lingual surface) 6. Aspiration performed to rule out intravascular needle placement 7. Injection of local anesthetic solution (1.8 mL of 2% lidocaine with 1:100,000 epinephrine) 8. Needle carefully withdrawn following injection completion | Procedure or surgery | Benzocaine group: Topical anesthesia using 20% benzocaine, before anesthetic punction., Cryanesthesia. Topical anesthesia using application of ice cones, before anesthesic punction. |
Primary outcome
Pain perception
Time frame: Baseline: At the time of the anesthetic injection (or needle puncture) at the oral mucosa.
Pain intensity was assessed using a validated instrument: Wong-Baker FACES® Pain Rating Scale (Visual Analog Scale): Immediately following completion of infiltration anesthesia injection, the participant was asked to indicate the level of pain experienced using the face scale (0 = no hurt to 10 = hurts worst).
3 secondary outcomes
Heart Rate
Time frame: Periprocedural: During the injection anesthetic procedure, from the anesthetic solution injection to the removal of the needle (approximately 45 seconds)
Oxygen saturation
Time frame: Periprocedural: During the injection anesthetic procedure, from the needle puncture to the removal of the needle (approximately 45 seconds).
Patient's behavioral response
Time frame: Periprocedural: 45 seconds, from the anesthetic injection to the removal of the needle.
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 20 Jan 2026.
- Background: PubMed 40110448Ninawe N, Anija CK. Comparative Evaluation of Effectiveness of Benzocaine Gel and Ice for Pain Management in Children during Local Anesthetic Administration by CCLAD: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Jan;18(1):19-23. doi: 10.5005/jp-journals-10005-3045. Epub 2025 Feb 14.
- Background: PubMed 32617406Tirupathi SP, Rajasekhar S. Effect of precooling on pain during local anesthesia administration in children: a systematic review. J Dent Anesth Pain Med. 2020 Jun;20(3):119-127. doi: 10.17245/jdapm.2020.20.3.119. Epub 2020 Jun 24.
- Background: PubMed 26379379Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
- Step-by-step instructions for performing oral cryotherapyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Amaury Pozos Guillén, Ph.D. study director
Universidad Autónoma de San Luis Potosi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Local Anesthesia (lidocaine hydrochloride) in people with Local Anesthetic Infiltration and Topical Anesthesia, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 6 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 20 Jan 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain perception (time frame: Baseline: At the time of the anesthetic injection (or needle puncture) at the oral mucosa.). 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 NCT07351383, which also lists 3 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 20 Jan 2026.