Clinical trial NCT05830747: Effect of Pre-emptive Dose of Prednisone Versus Placebo in Impacted Third Molar Surgery
Official title: Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Swelling
Tooth Position Anomalies
Tooth, Impacted
Tooth Extraction Status Nos
Tooth Avulsion
Keywords: third molar surgery
facial swelling
3D facial swelling evaluation
tooth impacted
prednisone drug administration
corticosteroids administration
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.

Detailed description: This study aims to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus, and pain after surgical removal of M3M in a split-mouth randomized controlled clinical trial. Facial swelling will be evaluated using an innovative three-dimensional digital technique.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 32 years who required both M3M extractions were recruited
* Good health status
* Indication to surgical extraction of both M3M
* Complete root formation
* Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification

Exclusion Criteria:

* Person under the age of 18 or over 32
* Allergy or contraindications to administration of corticosteroids
* Acute infection in any of the teeth to be extracted
* Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
* Pregnancy or breastfeeding
* History of treatment with antiresorptive drugs
* Chronic kidney disease
* History of systemic corticosteroid therapy in the past 4 weeks

Primary outcomes:
measure: Change in facial swelling
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Change in facial swelling
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Secondary outcomes:
measure: Change in trismus
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Change in pain with Visual analogue scale (VAS)
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Magna Graecia University of Catanzaro
state: CZ
Study officials:
affiliation: Magna Graecia University of Catanzaro
name: Alessandro Antonelli, PhDs, DDS
role: PRINCIPAL_INVESTIGATOR
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