Vurdering af det operative forløb i forbindelse med fjernelse af mandiblens 3. molar med særligt henblik på forekomsten af smerte og hævelse

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000866-22-DK

Enrollment

Unknown

Registered

2008-03-31

Start date

2008-05-15

Completion date

Unknown

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain after surgical removal of lower third molars MedDRA version: 9.1 Level: LLT Classification code 10051059 Term: Oral surgery

Interventions

Trade Name: Marcain-adrenalin Product Name: Marcain-adrenalin Pharmaceutical Form: Solution for injection INN or Proposed INN: bupivacaine Concentration unit: mg/ml milligram(s)/millilitre Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy individuals, minimum age 18, have two partially or fully non-erupted lower third molars 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: pregnancy, age under 18, use of medication (except oral contraceptives), need for sedation during surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the postoperative discomfort (especially pain and swelling) after surgical removal of lower third molars using 1) lidocaine, 2) lidocain combined with methylprednisolone, 3) bupivacaine and 4) bupivacaine combined with methylprednisolone.;Secondary Objective: ;Primary end point(s): pain measurements (100 mm VAS scale) and swelling (thermography)	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026