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Completed

NCT Number: NCT03335683

Phytotherapy Agent in Third Molar Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Messina

Messina, 98125, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 and 30 years;
  • good general health;
  • 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

  • any systemic condition which might affect the study;
  • taking medications;
  • use of hormonal contraceptives;
  • medication by anti-inflammatory and immunosuppressive drugs;
  • status of pregnancy or lactation;
  • previous history of excessive drinking;
  • allergy to local anesthetic;
  • smoking.

Treatment and study plan

Lenidase

Drug

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

Other names: Placebo

Primary outcomes

  1. Pain

    Time frame: 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 outcomes

  1. Swelling

    Time frame: 10 days

    Facial measure: swelling on the facial side receiving surgery. Measurement tragus to the nasal border (Tr-Al).

Sponsors and collaborators

Lead sponsor

Gaetano Isola, DDS, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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