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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03335683
Other study ID # 09/17
Secondary ID
Status Completed
Phase Phase 4
First received October 29, 2017
Last updated November 3, 2017
Start date January 7, 2016
Est. completion date June 30, 2017

Study information

Verified date November 2017
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lenidase
drug per os twice day for 7 days, or for 10 days

Locations

Country Name City State
Italy University of Messina Messina

Sponsors (1)

Lead Sponsor Collaborator
Gaetano Isola, DDS, PhD

Country where clinical trial is conducted

Italy, 

Outcome

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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