Ice to reduce pain before dental injectio

Phase 1

Conditions: The patients should be < 20 years and reffered by an orthodontist with two contra lateral premolars in the upper jaw that has to be extracted. They should not have any diseases or medications that, according to the investigator, affects the security of the patient or the quality of the study. Furthermore, they should not have dental fear.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-005305-31-SE

Lead Sponsor: Folktandvården Östergötland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

•The patients should have two contra lateral premolars in the upper jaw that are going to be extracted orthodontically after a referral from an orthodontist
•Age < 20år
•Informed consent from patient and legal guardian when necessary (<18 years)

Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Disease or medication that according to the investigator affects the security of the patient or the quality of the study.
•Expressed dental fear according to health declaration or according to the investigator.
•Hypersensitivity to local anesthesia of amide type or to any of the other ingredients.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to evaluate if the anesthetic effect and the patients' subjective experience is better when using cold than when using Lidocain gel 5%.;Secondary Objective: Not applicable;Primary end point(s): According to the vas scale we expect ice to be at least 4mm lower on a 100mm vas scale.;Timepoint(s) of evaluation of this end point: Baseline, 1min, 2,5min and 5min after application of local anaesthesia and after injection.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 70% of the patients will prefer ice over lidocain gel.;Timepoint(s) of evaluation of this end point: Questionnaire after the last visit