Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Anesthetic Spray | Experimental | Application of 10% lidocaine spray to the oral mucosa before local anesthesia. |
|
| Cryotherapy | Experimental | Application of an ice pen to the oral mucosa for 60 seconds before local anesthesia. |
|
| Combination Arm Type: Experimental | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% lidocaine spray | Drug | Topical application of 10% lidocaine spray to reduce injection pain. |
|
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harran University Faculty of Dentristry,Departman of Endodonti | Sanliurfa | Outside of the US | 63300 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Ice Pen (Cryotherapy) | Other | Pre-cooling the injection site using an ice pen for 60 seconds. |
|