Clinical trial related to the effect of different painkillers (etoricoxib and celecoxib). How do these medicaments reduce the pain after the removal of a lower wisdom tooth?

Phase 1

• Conditions: postoperative pain; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-001638-37-HU
• Lead Sponsor: Semmelweis Egyetem Fogorvostudományi Kar Arc- Állcsont- Szájsebészeti és Fogászati Klinika, Budapest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-05
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

female and male patients aged between 18 and 30, without any current medical conditions or existing in the medical history.

class I and II, A and B positioned (Pell & Gregory) wisdom teeth will be removed (with the exception of Class II B- due to the more invasive surgery a longer healing period is suspected)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded if the following conditions exist:

- patients under medication (we would like to avoid the interactions)
- patients who have taken any type of a painkiller during the week prior to the surgery
- smokers (longer healing period is suspected)
- pregnancy
- patients in breast feeding period
- patients with allergy for the examined medicaments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: to evaluate the necessity of the preventive usage of selective COX-2 inhibitors prior to M3M surgery;Primary end point(s): The volume of the postoperative pain will be estimated by the patients on a Visual Analog Scale where 0 means no pain et all ad 10 equals the unbearable pain;Timepoint(s) of evaluation of this end point: pain should be registered in the first 8 hours after the surgery and on the next day of the intervention in three different timepoints (09:00, 15:00 és 21:00);Main Objective: to compare the preventive painkiller efficacy of the examined substances (celecoxib and etoricoxib)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): the rate of the discomfort will be registered on a verbal rating scale (VRS-4);Timepoint(s) of evaluation of this end point: the discomfort should be registered in the first 8 hours after the surgery and on the next day of the intervention in three different timepoints (09:00, 15:00 és 21:00)