Oral Soft Tissue Conditions
Conditions
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).
Interventions
DRUGLenidase
drug per os twice day for 7 days, or for 10 days
Sponsors
Gaetano Isola, DDS, PhD
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Triple blind
Intervention model description
Split mouth design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 10 days | visual analogue scale (VAS), a score of 1 to 10. A score of 0 indicated no pain and 10, the worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swelling | 10 days | Facial measure: swelling on the facial side receiving surgery. Measurement tragus to the nasal border (Tr-Al). |
Countries
Italy
Outcome results
None listed