Trapezoidal Flap vs. Envelope Flap in Mandibular Third Molar Extraction.

April 17, 2014 updated by: nicola baldini, University of Firenze and Siena, Napoli, Italy

Trapezoidal Flap Versus Envelope Flap in Impacted Mandibular Third Molar Extraction

the purpose of this study was to test the effectiveness of the envelope flap compared to trapezoidal flap in impacted mandibular third molar extractions.

Study Overview

Status

Completed

Conditions

Impacted Third Molar Tooth

Detailed Description

a sample of 50 patients requiring mandibular third molar extraction was selected for the study. Healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study. A total number of 52 consecutive cases of mandibular third molar surgical extractions were performed using either a trapezoidal flap or an envelope flap. The choice of the flap was randomized. The following parameters were recorded: Probing Pocket Depth, Clinical Attachment Level, Bleeding on Probing, Full Mouth Plaque Score, Full Mouth Bleeding Score, total time for the surgical intervention, age of the patient, type of inclusion, ostectomy. All the patients received a questionnaire to evaluate the post-intervention discomfort (swelling, pain, number of pain-killers, bleeding). Periodontal parameters were checked at 6-month follow up.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Siena, Italy, 53100
    - Tuscan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

a sample of 50 patients requiring mandibular third molar extracion was selected for the study. Healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study

Description

Inclusion Criteria:

third molar impaction
mild symptoms of pericoronitis

Exclusion Criteria:

systemic diseases
cigarettes smoking
history of irradiation therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
test envelope envelope flap
control, trapezodal standard incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline on the periodontal status of adjacent second molar Time Frame: 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
post surgical complication Time Frame: 2 weeks	2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Firenze and Siena, Napoli, Italy

Investigators

Principal Investigator: nicola nb baldini, oral surgeon, tuscan scool of dental medicine of florence and siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Estimate)