Oral Soft Tissue Conditions Clinical Trial
Official title:
The Effects of a Phytotherapy Agent in Third Molar Surgery: a Split-mouth, Prospective, Randomized Study
Verified date | November 2017 |
Source | University of Messina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 20, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | University of Messina | Messina |
Lead Sponsor | Collaborator |
---|---|
Gaetano Isola, DDS, PhD |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain | visual analogue scale (VAS), a score of 1 to 10. A score of 0 indicated no pain and 10, the worst pain. | 10 days | |
Secondary | Swelling | Facial measure: swelling on the facial side receiving surgery. Measurement tragus to the nasal border (Tr-Al). | 10 days |
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