Local Anesthesia InfiltrationNCT07682181
Efficacy of Facial Massager in Reducing Intra Oral Injection Pain in Pediatric Patients
A study testing Facial T massager and Topical Benzocaine 20% in people with Local Anesthesia Infiltration, run by Government Dental College and Hospital, India.
Trial summary
Abstract Background: Local anesthesia is a primary source of anxiety in pediatric dentistry. Objective: To evaluate if mechanical vibration from a low-cost facial massager reduces pain and anxiety during injections using the Gate Control Theory. Design: Prospective Randomized Controlled Trial . Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia Infiltration
- What is being tested?
- Facial T massager and Topical Benzocaine 20%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-12 years requiring local anesthesia
- Cooperative behaviour (frankl rating 3,4)
Who cannot join
- History of allergy to benzocaine
- acute infection at the site
- special healthcare needs affecting sensory perception
- Medically compromised children
- unco-operative children
- those who do not consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of a Vibrating Facial-T- Massager as an Adjunct to Topical Anesthesia in Reducing Intraoral Injection Pain in Children: A Randomized Controlled Trial.
Abstract
- Background: Local anesthesia is a primary source of anxiety in pediatric dentistry.
- Objective: To evaluate if mechanical vibration from a low-cost facial massager reduces pain and anxiety during injections using the Gate Control Theory.
- Design: Prospective Randomized Controlled Trial .
Read the detailed description
Methodology \& Study Design
- Setting: Pediatric Dental Department, Kadapa, Andhra Pradesh.
- Inclusion Criteria: Children aged 4-12 years requiring local anesthesia, cooperative (frankl 3,4)
- Exclusion Criteria: History of allergy to benzocaine, acute infection at the site, or special healthcare needs affecting sensory perception, Medically compromised, unco-operative children, those who do not consent.
Intervention Protocol
- Group 1: Application of 20% Benzocaine gel for 2 minutes followed by a standard local anesthetic injection.
- Group 2: Application of Facial Massager on the buccal mucosa 30 seconds prior to and during the injection.
- Group 3: Application of 20% Benzocaine gel for 2 minutes + Facial Massager applied to the buccal mucosa 30 seconds prior to and during the injection.
- Infection Control \& Sterilization
To ensure patient safety, the following protocol for the non-medical T-massager will be implemented:
- Barrier Protection: The device will be encased in a single-use, disposable polyethylene sleeve (Digital Sensor Sleeve) and secured with tape.
- Disinfection: After barrier removal, a "Double-Wipe" method using 70% Isopropyl Alcohol wipe will be used.
- Conditions
- Local Anesthesia Infiltration
- Being tested
- Facial T massager, Topical Benzocaine 20%
- Keywords
- local anesthesia, local infiltration, massager, vibrating device, Topical Benzocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial T massagerDevice
vibrating facial T massager used to apply on mucosa for mechanical stimulation and gate control
Topical Benzocaine 20%Drug
topical application of mucopain gel for 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| benzocaine group | Active comparator | 20% topical benzocaine Receives: Drug: Topical Benzocaine 20% |
| vibrating T massager | Experimental | Facial T Massager producing local vibration on mucosal application Receives: Device: Facial T massager |
| combination | Experimental | combination of benzocaine and massager Receives: Device: Facial T massager; Drug: Topical Benzocaine 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
self reort of pain
wong-baker faces pain rating scale with face emoji rating no pain as score zero to score ten as that huts worst.
Measured: after injection
Secondary outcomes (1)
physiologic parameter
measuring heart rate pre and during injection of local Anesthesia
Measured: pre and during administration of local anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Local Anesthesia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Hospital, India
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jaya chandra Reddy Bhumireddy, Government Dental College and Hospital, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682181
- Sponsor's protocol ID
- pr.69/IEC/GDCH/KDP/2025-2026
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data. The aggregated, analyzed results of this clinical trial comparing the intraoral massager and benzocaine gel will be disseminated via publication in a peer-reviewed scientific journal.
Publications
Hambouta HM, Sharaf DA, Wahba NA. Effectiveness of cold vibratory stimuli on pain perception governing infiltration anesthesia in the maxillary arch in children: a randomized controlled clinical trial. BMC Oral Health. 2025 Jun 3;25(1):900. doi: 10.1186/s12903-025-06170-4.
PubMed 40462040
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Vibrating Facial-T- Massager as an Adjunct to Topical Anesthesia in Reducing Intraoral Injection Pain in Children: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07682181
- Acronym / sponsor ID
- pr.69/IEC/GDCH/KDP/2025-2026
- Conditions
- Local Anesthesia Infiltration
- Keywords
- local anesthesia, local infiltration, massager, vibrating device, Topical Benzocaine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Government Dental College and Hospital, IndiaOther government
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jul 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.
Abstract
- Background: Local anesthesia is a primary source of anxiety in pediatric dentistry.
- Objective: To evaluate if mechanical vibration from a low-cost facial massager reduces pain and anxiety during injections using the Gate Control Theory.
- Design: Prospective Randomized Controlled Trial .
Detailed description
Methodology \& Study Design
- Setting: Pediatric Dental Department, Kadapa, Andhra Pradesh.
- Inclusion Criteria: Children aged 4-12 years requiring local anesthesia, cooperative (frankl 3,4)
- Exclusion Criteria: History of allergy to benzocaine, acute infection at the site, or special healthcare needs affecting sensory perception, Medically compromised, unco-operative children, those who do not consent.
Intervention Protocol
- Group 1: Application of 20% Benzocaine gel for 2 minutes followed by a standard local anesthetic injection.
- Group 2: Application of Facial Massager on the buccal mucosa 30 seconds prior to and during the injection.
- Group 3: Application of 20% Benzocaine gel for 2 minutes + Facial Massager applied to the buccal mucosa 30 seconds prior to and during the injection.
- Infection Control \& Sterilization
To ensure patient safety, the following protocol for the non-medical T-massager will be implemented:
- Barrier Protection: The device will be encased in a single-use, disposable polyethylene sleeve (Digital Sensor Sleeve) and secured with tape.
- Disinfection: After barrier removal, a "Double-Wipe" method using 70% Isopropyl Alcohol wipe will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| benzocaine group | Active comparator | Drug: Topical Benzocaine 20%20% topical benzocaine |
| vibrating T massager | Experimental | Device: Facial T massagerFacial T Massager producing local vibration on mucosal application |
| combination | Experimental | Device: Facial T massager, Drug: Topical Benzocaine 20%combination of benzocaine and massager |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 4-12 years requiring local anesthesia
- Cooperative behaviour (frankl rating 3,4)
Key exclusion criteria (6 listed)
- History of allergy to benzocaine
- acute infection at the site
- special healthcare needs affecting sensory perception
- Medically compromised children
- unco-operative children
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 |
|---|---|---|
| Facial T massagervibrating facial T massager used to apply on mucosa for mechanical stimulation and gate control | Device | combination, vibrating T massager |
| Topical Benzocaine 20%topical application of mucopain gel for 30 seconds | Drug | benzocaine group, combination |
Primary outcome
self reort of pain
Time frame: after injection
wong-baker faces pain rating scale with face emoji rating no pain as score zero to score ten as that huts worst.
1 secondary outcome
physiologic parameter
Time frame: pre and during administration of local anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 40462040Hambouta HM, Sharaf DA, Wahba NA. Effectiveness of cold vibratory stimuli on pain perception governing infiltration anesthesia in the maxillary arch in children: a randomized controlled clinical trial. BMC Oral Health. 2025 Jun 3;25(1):900. doi: 10.1186/s12903-025-06170-4.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data. The aggregated, analyzed results of this clinical trial comparing the intraoral massager and benzocaine gel will be disseminated via publication in a peer-reviewed scientific journal.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Facial T massager and Topical Benzocaine 20% in people with Local Anesthesia Infiltration, run by Government Dental College and Hospital, India.
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 2 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: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jayachandra Assistant professor, MDS (+91-9490088514, dr.jayachandra2509@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self reort of pain (time frame: after injection). 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 NCT07682181, 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 2 Jul 2026.