Clinical trial NCT03335683: Phytotherapy Agent in Third Molar Surgery
Official title: The Effects of a Phytotherapy Agent in Third Molar Surgery: a Split-mouth, Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Soft Tissue Conditions
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split mouth design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. age between 18 and 30 years;
2. good general health;
3. the presence of two asymptomatic mandibular third molars with Class II position B impaction (Pell and Gregory, 1933), with similar root formation characteristics and position; absence of pericoronitis or signs of inflammation during the last 30 days. Ortopantomography (OPT) was used to determine tooth position.

Exclusion Criteria:

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.

Primary outcomes:
measure: Pain
timeFrame: 10 days
Secondary outcomes:
measure: Swelling
timeFrame: 10 days
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: Univeristy of Messina
name: Giovanni Matarese, DDS
role: STUDY_DIRECTOR
References: