Comparing Pre-Anesthetic Approaches in Dentistry

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.

Study Overview

• Status: Completed
• Conditions: Pain; Injection Site Pain
• Intervention / Treatment: Drug: 10% lidocaine spray; Other: Ice Pen (Cryotherapy)

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 Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Outside of the US
    • Sanliurfa, Outside of the US, Turkey (Türkiye), 63300
      • Harran University Faculty of Dentristry,Departman of Endodonti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Anesthetic Spray; Application of 10% lidocaine spray to the oral mucosa before local anesthesia.	Drug: 10% lidocaine spray; Topical application of 10% lidocaine spray to reduce injection pain.
Experimental: Cryotherapy; Application of an ice pen to the oral mucosa for 60 seconds before local anesthesia.	Other: Ice Pen (Cryotherapy); Pre-cooling the injection site using an ice pen for 60 seconds.
Experimental: Combination Arm Type: Experimental; Application of an ice pen for 60 seconds followed by 10% lidocaine spray before local anesthesia.	Drug: 10% lidocaine spray; Topical application of 10% lidocaine spray to reduce injection pain.; Other: Ice Pen (Cryotherapy); Pre-cooling the injection site using an ice pen for 60 seconds.
No Intervention: Control; Standard local anesthesia injection without any pre-anesthetic intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (SEM score).	During the initial local anesthesia needle insertion.

Collaborators and Investigators

• Sponsor: Harran University

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Actual): July 1, 2026
• Study Completion (Actual): July 1, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cryotherapy; Dental Anesthesia; Topical Anesthesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Therapeutics; Cryotherapy
• Other Study ID Numbers: HRÜ/26.02.87

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No