Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15+
SponsorEMS
About this trial
The purpose of this study is to evaluate the efficacy and safety of DIT112 in adolescents and adults with acute pain after dental surgery for the extraction of impacted third molars.
Eligibility criteria
Qualifiers
Ability to confirm voluntary participation and agree with all the purposes of the trial, signing and dating the Free and Informed Consent Form (TCLE) and/or the Free and Informed Assent Form (TALE) in two copies;
Age equal to or over 15 years old;
Indication of extraction of two (02) impacted third molars, one (01) lower third molar and one (01) upper molar on the same side;
Presence of pain of moderate or severe intensity (score greater than or equal to 5 when assessed using an 11-point numeric pain scale) within up to four (04) hours after the end of the surgery.
Disqualifiers
Presence of local conditions (lesions in the region of the third molars) that may interfere with the extraction of third molars, such as, but not limited to, pericoronitis, periodontitis, tumors, cysts and inflammation and/or infection in the region to be operated;
Presence of any clinical observation finding (clinical/physical assessment) or laboratory condition that is interpreted by the investigating physician as a risk to the research participant's participation in the clinical trial or the presence of uncontrolled chronic disease(s);
Presence of a known gastroduodenal ulcer or diagnosis of persistent gastritis;
Presence of compromised bone marrow function or diseases of the hematopoietic system;
Trial design
Treatments tested in this trial
- DIT112
- DIPYRONE
- TRAMADOL
- DIT112 Placebo
- Dipyrone Placebo
- Tramadol Placebo
Treatment groups
252 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov