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Phytotherapy Agent in Third Molar Surgery

NCT ID: NCT03335683

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-07

Study Completion Date

2017-06-30

Brief Summary

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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

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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).

Conditions

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Oral Soft Tissue Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split mouth design
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Triple blind

Study Groups

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Phytoterapy agent

Subjects were allocated to receive 1 h and 12 h after surgery: group 1, Lenidase® (Enfarma SRL, Misterbianco, Italy)

Group Type EXPERIMENTAL

Lenidase

Intervention Type DRUG

drug per os twice day for 7 days, or for 10 days

Placebo

Subjects were allocated to received 1 h and 12 h after surgery: placebo (Sugar pill, Sucratol - Placebo Capsules).

Group Type PLACEBO_COMPARATOR

Lenidase

Intervention Type DRUG

drug per os twice day for 7 days, or for 10 days

Interventions

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Lenidase

drug per os twice day for 7 days, or for 10 days

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gaetano Isola, DDS, PhD

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola, DDS, PhD

Dr. Gaetano Isola

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Giovanni Matarese, DDS

Role: STUDY_DIRECTOR

Univeristy of Messina

Locations

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University of Messina

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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09/17

Identifier Type: -

Identifier Source: org_study_id