NCT03335683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

October 29, 2017

Last Update Submit

November 3, 2017

Conditions

Oral Soft Tissue Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Swelling

    10 days

Study Arms (2)

Phytoterapy agent

EXPERIMENTAL

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

Drug: Lenidase

Placebo

PLACEBO COMPARATOR

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

Drug: Lenidase

Interventions

LenidaseDRUG

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

Also known as: Placebo
Phytoterapy agentPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Messina

Messina, 98125, Italy

Location

MeSH Terms

Interventions

Lenidase

Study Officials

  • Giovanni Matarese, DDS

    Univeristy of Messina

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple blind
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Split mouth design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Gaetano Isola

Study Record Dates

First Submitted

October 29, 2017

First Posted

November 8, 2017

Study Start

January 7, 2016

Primary Completion

June 20, 2017

Study Completion

June 30, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

IT(1)