Different dosis of corticosteroids in mandibular third molar surgery.

Different dosis of corticosteroids in mandibular third molar surgery. A randomized, blinded clinical trial assessing pain, trismus, edema, and quality of life outcome measurements.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000622-35-DK

Enrollment

Registered

2017-06-30

Start date

2017-10-23

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

The purpose is to investigate the postoperative morbidity after removal of mandibular third molar with different doses of methylprednisolone. MedDRA version: 20.0 Level: LLT Classification code 10036278 Term: Postoperative complications NOS System Organ Class: 100000004863

Interventions

Trade Name: Solu-medrol® Product Name: Methylprednisolone Product Code: SUB08872MIG Pharmaceutical Form: Concentrate and solvent for solution for inject

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Bilateral symmetrical impacted mandibular third molars. Indication for removal of mandibular third molars. Age between 18 and 40 years. 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 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: No indication for removal of mandibular third molars. Unilateral mandibular third molar. Infections and inflammatory symptoms in the oral cavity at the time of surgery. Previous maxillofacial trauma. Craniofacial clefts or syndromes. Systemic bone disease (i.e. arthritis) or diabetes mellitus. Active acne vulgaris, viral, and fungal infections. Psychological disease. Failure to attend follow-up.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of treatment with intramuscular methylprednisolone on the postoperative morbidity after removal of mandibular third molar.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: One, three, seven, and 30 days postoperatively.; Primary end point(s): Facial appearance changes as evaluated by three-dimensional stereophotography. Mouth opening. Surgical complications. Blood samples. QOL assessment (OHIP-14). Pain and swelling assess by visual analog scale (VAS).	—

Measure

Time frame

Main Objective: To investigate the effects of treatment with intramuscular methylprednisolone on the postoperative morbidity after removal of mandibular third molar.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: One, three, seven, and 30 days postoperatively.; Primary end point(s): Facial appearance changes as evaluated by three-dimensional stereophotography. Mouth opening. Surgical complications. Blood samples. QOL assessment (OHIP-14). Pain and swelling assess by visual analog scale (VAS).

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactDepartment of Oral and Maxillofacia

Aalborg University Hospital

004597 66 00 00

Outcome results

None listed

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