Oral Soft Tissue Conditions Clinical Trial
Official title:
The Effects of a Phytotherapy Agent in Third Molar Surgery: a Split-mouth, Prospective, Randomized Study
The aim of the present study was to evaluate the effect of a phytotherapy agent on clinical and inflammatory parameters, for the postoperative therapy of the impacted third molar surgery. The null hypothesis to invalidate was that, after the last follow-up, there were no variations between the phytotherapy agent and the placebo.
The inclusion criteria were: (1) age between 18 and 32 years; (2) good general health; (3)
the presence of two asymptomatic mandibular third molars with Class II position, type B
impaction (Pell and Gregory, 1933), with similar root formation characteristics and position
between the two sides; (4) absence of pericoronitis or signs of inflammation during the last
30 days. Orthopantomography (OPT) was used to determine tooth position. The exclusion
criteria were (1) any systemic condition which might affect the study; (2) taking
medications; (3) use of hormonal contraceptives; (4) medication by anti-inflammatory and
immunosuppressive drugs; (5) status of pregnancy or lactation; (6) previous history of
excessive drinking; (7) allergy to local anesthetic; (8) smoking.
The study was performed according to the CONSORT (Consolidated Standards Of Reporting Trials)
guidelines. Patients who did not attend the second surgery or were unable to follow the study
protocol were excluded, as were those whose surgical time exceeded 40 minutes.
Patients were scheduled for surgery in two separate clinical sessions (one side at a time),
with a 1-month interval. Subjects were allocated to one of two groups according to the
medication received 1 h and 12 h after surgery: group 1, Lenidase® (Enfarma SRL,
Misterbianco, Italy); group 2, placebo (Sugar pill, Sucratol - Placebo Capsules). All
patients in the study routinely received a prophylactic preoperative dose of oral antibiotic
(1 g amoxicillin/clavulanic acid 1 hour before surgery) (Augmentin; GlaxoSmithKline, Verona,
Italy).
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