Injection Site PainNCT07703553
Comparing Pre-Anesthetic Approaches in Dentistry
A study testing 10% lidocaine spray and Ice Pen (Cryotherapy) in people with Injection Site Pain and Pain, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of this study is to find out which pre-treatment method works best to reduce pain from dental anesthesia injections in adult patients. Researchers will compare four different approaches: Topical numbing spray (10% lidocaine) Brief cold application (cryotherapy) A combination of both cold application… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Pain, Pain
- What is being tested?
- 10% lidocaine spray and Ice Pen (Cryotherapy)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 1 Jul 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 65 years.
- Systemically healthy individuals classified as ASA I or II.
- Patients presenting to the Harran University Faculty of Dentistry Hospital who require local anesthesia during dental treatment.
- Treatment plan requiring mandibular block anesthesia, anterior/posterior infiltration, or palatal infiltration.
- No regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days.
- No history of allergy to cold application or topical anesthetics.
Who cannot join
- Regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days.
- Chronic pain syndrome, migraine, or systemic diseases requiring continuous use of analgesics.
- Pregnancy or lactation.
- Presence of active lesions in the oral mucosa, severe periodontal infection, or pathology at the injection site.
- History of allergy to topical gel or cold application.
- Psychiatric disorders or conditions preventing compliance with dental treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Harran University Faculty of Dentristry,Departman of Endodonti
Sanliurfa, Outside of the US, 63300
About this study
Official title: Comparison of Pre-Anesthetic Approaches to Reduce Needle Insertion Pain Before Dental Local Anesthesia.
The main purpose of this study is to find out which pre-treatment method works best to reduce pain from dental anesthesia injections in adult patients. Researchers will compare four different approaches:
Topical numbing spray (10% lidocaine) Brief cold application (cryotherapy) A combination of both cold application and cooled numbing spray A control group Participants who need a standard local anesthesia injection for their dental treatment will be randomly assigned to one of these four groups. Right after the needle insertion, participants will rate their pain level using a simple visual scale, and their physical reactions will also be observed and scored by the researchers.
Read the detailed description
Local anesthesia injection is one of the stages that causes the most fear and discomfort in patients during dental procedures. While topical anesthetics are widely used to reduce this discomfort, their effectiveness can be limited. Cryotherapy is a simple and economical method that provides short-term analgesia by slowing nerve conduction and raising the pain threshold. Although the literature shows that cryotherapy is effective in reducing injection pain in pediatric patients, randomized controlled trials comparing different methods in adult individuals are limited. Fear of needles and injection pain are important factors that negatively affect compliance with dental treatment. Proving the effectiveness of simple, inexpensive, and side-effect-free methods will increase patient comfort and elevate treatment success in clinical practice. In particular, the combination of cryotherapy and a topical anesthetic can minimize injection pain by providing a stronger analgesic effect. This study aims to fill the gap in the literature regarding adult patients by revealing the comparative effectiveness of different pre-anesthetic approaches in pain control before dental local anesthesia. In this prospective, randomized, controlled clinical trial, adult participants will be randomly divided into four groups to evaluate the pre-anesthetic protocols: Topical anesthetic spray group: Application of 10% lidocaine spray to the mucosa. Cold application group: Gentle contact of an ice pen (cryotherapy) to the mucosa for 60 seconds. Combination group: Cold application for 60 seconds, followed by the application of cooled 10% lidocaine spray. Control group: Standard procedure with a placebo control. Following the pre-anesthetic mucosal preparation, standard local anesthesia will be administered using 1.8 mL of 4% articaine with 1:100,000 epinephrine. Pain measurements will be conducted separately for three different injection sites: mandibular block anesthesia, buccal infiltrative anesthesia in anterior and posterior regions, and palatal infiltration anesthesia. During the initial needle insertion, pain levels will be assessed subjectively using a Visual Analog Scale (VAS) and objectively by the researchers using the Sound-Eye-Motor (SEM) scale.
- Conditions
- Injection Site Pain, Pain
- Being tested
- 10% lidocaine spray, Ice Pen (Cryotherapy)
- Keywords
- Dental Anesthesia, Cryotherapy, Topical Anesthesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% lidocaine sprayDrug
Topical application of 10% lidocaine spray to reduce injection pain.
Ice Pen (Cryotherapy)Other
Pre-cooling the injection site using an ice pen for 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Topical Anesthetic Spray | Experimental | Application of 10% lidocaine spray to the oral mucosa before local anesthesia. Receives: Drug: 10% lidocaine spray |
| Cryotherapy | Experimental | Application of an ice pen to the oral mucosa for 60 seconds before local anesthesia. Receives: Other: Ice Pen (Cryotherapy) |
| Combination Arm Type: Experimental | Experimental | Application of an ice pen for 60 seconds followed by 10% lidocaine spray before local anesthesia. Receives: Drug: 10% lidocaine spray; Other: Ice Pen (Cryotherapy) |
| Control | No intervention | Standard local anesthesia injection without any pre-anesthetic intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during initial needle insertion (VAS)
Subjective pain levels will be assessed by participants using a Visual Analog Scale (VAS) ranging from 0 to 10 mm. Higher scores indicate greater pain.
Measured: During the initial local anesthesia needle insertion.
Secondary outcomes (1)
Objective pain assessment using Sound-Eye-Motor (SEM) scale
Pain levels will be assessed objectively by the researchers based on the participants' sound, eye, and motor reactions using the Sound, Eye, and Motor (SEM) scale. Total scores range from 0 to 5, where higher scores indicate greater pain.
Measured: During the initial local anesthesia needle insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start23 Feb 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
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 Injection Site PainStudies 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
- Model description
- This is a randomized, parallel-group clinical trial. Participants are randomly assigned to one of four independent groups: 1) topical anesthetic spray group, 2) cryotherapy (cold application) group, 3) combination group (cryotherapy followed by topical spray), and 4) placebo control group. Each participant receives only the specific pre-anesthetic intervention assigned to their group before the administration of standard local dental anesthesia.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet AKAY, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703553
- Sponsor's protocol ID
- HRÜ/26.02.87
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to maintain patient confidentiality and privacy, in strict accordance with the informed consent form approved by the local ethics committee.
Publications
1. Chandrasekaran, J., et al., Efficacy of painless injection technique-Vibraject-Clinical trial in Chennai, India. 2014. 2. Kumar, M., R. Chawla, and M. Goyal, Topical anesthesia. Journal of Anaesthesiology Clinical Pharmacology, 2015. 31(4): p. 450-456. 3. Ghaderi, F., S. Banakar, and S. Rostami, Effect of pre-cooling injection site on pain perception in pediatric dentistry:"A randomized clinical trial". Dental research journal, 2013. 10(6): p. 790. 4. Aminabadi, N.A. and R.M.Z. Farahani, The effect of pre-cooling the injection site on pediatric pain perception during the administration of local anesthesia. The journal of contemporary dental practice, 2012. 10: p. 43-50. 5. Lakshmanan, L. and V. Ravindran, Efficacy of cryotherapy application on the pain perception during intraoral injection: a randomized controlled trial. International Journal of Clinical Pediatric Dentistry, 2021. 14(5): p. 616. 6. Wiswall, A.T., Palatal anesthesia: comparison of four techniques for decreasing injection discomfort. 2011.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-Anesthetic Approaches to Reduce Needle Insertion Pain Before Dental Local Anesthesia.
- ClinicalTrials.gov ID
- NCT07703553
- Acronym / sponsor ID
- HRÜ/26.02.87
- Conditions
- Injection Site Pain, Pain
- Keywords
- Dental Anesthesia, Cryotherapy, Topical Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 14 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.
The main purpose of this study is to find out which pre-treatment method works best to reduce pain from dental anesthesia injections in adult patients. Researchers will compare four different approaches:
Topical numbing spray (10% lidocaine) Brief cold application (cryotherapy) A combination of both cold application and cooled numbing spray A control group Participants who need a standard local anesthesia injection for their dental treatment will be randomly assigned to one of these four groups. Right after the needle insertion, participants will rate their pain level using a simple visual scale, and their physical reactions will also be observed and scored by the researchers.
Detailed description
Local anesthesia injection is one of the stages that causes the most fear and discomfort in patients during dental procedures. While topical anesthetics are widely used to reduce this discomfort, their effectiveness can be limited. Cryotherapy is a simple and economical method that provides short-term analgesia by slowing nerve conduction and raising the pain threshold. Although the literature shows that cryotherapy is effective in reducing injection pain in pediatric patients, randomized controlled trials comparing different methods in adult individuals are limited. Fear of needles and injection pain are important factors that negatively affect compliance with dental treatment. Proving the effectiveness of simple, inexpensive, and side-effect-free methods will increase patient comfort and elevate treatment success in clinical practice. In particular, the combination of cryotherapy and a topical anesthetic can minimize injection pain by providing a stronger analgesic effect. This study aims to fill the gap in the literature regarding adult patients by revealing the comparative effectiveness of different pre-anesthetic approaches in pain control before dental local anesthesia. In this prospective, randomized, controlled clinical trial, adult participants will be randomly divided into four groups to evaluate the pre-anesthetic protocols: Topical anesthetic spray group: Application of 10% lidocaine spray to the mucosa. Cold application group: Gentle contact of an ice pen (cryotherapy) to the mucosa for 60 seconds. Combination group: Cold application for 60 seconds, followed by the application of cooled 10% lidocaine spray. Control group: Standard procedure with a placebo control. Following the pre-anesthetic mucosal preparation, standard local anesthesia will be administered using 1.8 mL of 4% articaine with 1:100,000 epinephrine. Pain measurements will be conducted separately for three different injection sites: mandibular block anesthesia, buccal infiltrative anesthesia in anterior and posterior regions, and palatal infiltration anesthesia. During the initial needle insertion, pain levels will be assessed subjectively using a Visual Analog Scale (VAS) and objectively by the researchers using the Sound-Eye-Motor (SEM) scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a randomized, parallel-group clinical trial. Participants are randomly assigned to one of four independent groups: 1) topical anesthetic spray group, 2) cryotherapy (cold application) group, 3) combination group (cryotherapy followed by topical spray), and 4) placebo control group. Each participant receives only the specific pre-anesthetic intervention assigned to their group before the administration of standard local dental anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Topical Anesthetic Spray | Experimental | Drug: 10% lidocaine sprayApplication of 10% lidocaine spray to the oral mucosa before local anesthesia. |
| Cryotherapy | Experimental | Other: Ice Pen (Cryotherapy)Application of an ice pen to the oral mucosa for 60 seconds before local anesthesia. |
| Combination Arm Type: Experimental | Experimental | Drug: 10% lidocaine spray, Other: Ice Pen (Cryotherapy)Application of an ice pen for 60 seconds followed by 10% lidocaine spray before local anesthesia. |
| Control | No intervention | –Standard local anesthesia injection without any pre-anesthetic intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged between 18 and 65 years.
- Systemically healthy individuals classified as ASA I or II.
- Patients presenting to the Harran University Faculty of Dentistry Hospital who require local anesthesia during dental treatment.
- Treatment plan requiring mandibular block anesthesia, anterior/posterior infiltration, or palatal infiltration.
- No regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days.
Key exclusion criteria (6 listed)
- Regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days.
- Chronic pain syndrome, migraine, or systemic diseases requiring continuous use of analgesics.
- Pregnancy or lactation.
- Presence of active lesions in the oral mucosa, severe periodontal infection, or pathology at the injection site.
- History of allergy to topical gel or cold application.
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 |
|---|---|---|
| 10% lidocaine sprayTopical application of 10% lidocaine spray to reduce injection pain. | Drug | Combination Arm Type: Experimental, Topical Anesthetic Spray |
| Ice Pen (Cryotherapy)Pre-cooling the injection site using an ice pen for 60 seconds. | Other | Combination Arm Type: Experimental, Cryotherapy |
Primary outcome
Pain intensity during initial needle insertion (VAS)
Time frame: During the initial local anesthesia needle insertion.
Subjective pain levels will be assessed by participants using a Visual Analog Scale (VAS) ranging from 0 to 10 mm. Higher scores indicate greater pain.
1 secondary outcome
Objective pain assessment using Sound-Eye-Motor (SEM) scale
Time frame: During the initial local anesthesia needle insertion.
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 10 Sep 2026.
- Results publication1. Chandrasekaran, J., et al., Efficacy of painless injection technique-Vibraject-Clinical trial in Chennai, India. 2014. 2. Kumar, M., R. Chawla, and M. Goyal, Topical anesthesia. Journal of Anaesthesiology Clinical Pharmacology, 2015. 31(4): p. 450-456. 3. Ghaderi, F., S. Banakar, and S. Rostami, Effect of pre-cooling injection site on pain perception in pediatric dentistry:"A randomized clinical trial". Dental research journal, 2013. 10(6): p. 790. 4. Aminabadi, N.A. and R.M.Z. Farahani, The effect of pre-cooling the injection site on pediatric pain perception during the administration of local anesthesia. The journal of contemporary dental practice, 2012. 10: p. 43-50. 5. Lakshmanan, L. and V. Ravindran, Efficacy of cryotherapy application on the pain perception during intraoral injection: a randomized controlled trial. International Journal of Clinical Pediatric Dentistry, 2021. 14(5): p. 616. 6. Wiswall, A.T., Palatal anesthesia: comparison of four techniques for decreasing injection discomfort. 2011.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to maintain patient confidentiality and privacy, in strict accordance with the informed consent form approved by the local ethics committee.
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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 10% lidocaine spray and Ice Pen (Cryotherapy) in people with Injection Site Pain and Pain, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 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 10 Sep 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 intensity during initial needle insertion (VAS) (time frame: During the initial local anesthesia needle insertion.). 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 NCT07703553, 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 10 Sep 2026.