Phytotherapy Agent in Third Molar Surgery

Oral Soft Tissue Conditions Clinical Trial

Official title:

The Effects of a Phytotherapy Agent in Third Molar Surgery: a Split-mouth, Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335683
• Other study ID #: 09/17
• 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
• 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.

Related Conditions & MeSH terms

• Oral Soft Tissue Conditions

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