Comparing Pre-Anesthetic Approaches in Dentistry

NCT07703553 | Completed

• 1 other identifier: HRÜ/26.02.87
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Injection Site Pain; Pain

Keywords

Dental Anesthesia; Cryotherapy; Topical Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  During the initial local anesthesia needle insertion.

Secondary Outcomes (1)

• Objective pain assessment using Sound-Eye-Motor (SEM) scale

  During the initial local anesthesia needle insertion.

Study Arms (4)

Topical Anesthetic Spray

EXPERIMENTAL

Application of 10% lidocaine spray to the oral mucosa before local anesthesia.

Drug: 10% lidocaine spray

Cryotherapy

EXPERIMENTAL

Application of an ice pen to the oral mucosa for 60 seconds before local anesthesia.

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.

Drug: 10% lidocaine spray; Other: Ice Pen (Cryotherapy)

Control

NO INTERVENTION

Standard local anesthesia injection without any pre-anesthetic intervention.

Interventions

10% lidocaine spray DRUG

Topical application of 10% lidocaine spray to reduce injection pain.

Combination Arm Type: Experimental; Topical Anesthetic Spray

Ice Pen (Cryotherapy) OTHER

Pre-cooling the injection site using an ice pen for 60 seconds.

Combination Arm Type: Experimental; Cryotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University Faculty of Dentristry,Departman of Endodonti

Sanliurfa, Outside of the US, 63300, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Pain

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: February 23, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)