Harran University Faculty of Dentristry,Departman of Endodonti
Sanliurfa, Outside of the US, 63300, Turkey (Türkiye)
NCT Number: NCT07703553
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Sanliurfa, Outside of the US, 63300, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Topical application of 10% lidocaine spray to reduce injection pain.
Pre-cooling the injection site using an ice pen for 60 seconds.
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.
Time frame: During the initial local anesthesia needle insertion.
Pain levels will be assessed objectively by the researchers based on the participants' sound, eye, and motor reactions (SEM score).
Harran University
Other
Comparison of Pre-Anesthetic Approaches to Reduce Needle Insertion Pain Before Dental Local Anesthesia.
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