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Phytotherapy Agent in Third Molar Surgery

Sponsor
Gaetano Isola, DDS, PhD (Other)
Overall Status
Completed
CT.gov ID
NCT03335683
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
17.7
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Split mouth designSplit mouth design
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Triple blind
Primary Purpose:
Treatment
Official Title:
The Effects of a Phytotherapy Agent in Third Molar Surgery: a Split-mouth, Prospective, Randomized Study
Actual Study Start Date :
Jan 7, 2016
Actual Primary Completion Date :
Jun 20, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phytoterapy agent

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

Drug: Lenidase
drug per os twice day for 7 days, or for 10 days
Other Names:
  • Placebo

    		•
    Placebo Comparator: Placebo

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

    Drug: Lenidase
    drug per os twice day for 7 days, or for 10 days
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain [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 Outcome Measures

    1. Swelling [10 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Messina Messina Italy 98125

    Sponsors and Collaborators

    • Gaetano Isola, DDS, PhD

    Investigators

    • Study Director: Giovanni Matarese, DDS, Univeristy of Messina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gaetano Isola, DDS, PhD, Dr. Gaetano Isola, University of Messina
    ClinicalTrials.gov Identifier:
    NCT03335683
    Other Study ID Numbers:
    • 09/17
    First Posted:
    Nov 8, 2017
    Last Update Posted:
    Nov 8, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 8, 2017