NCT02120131

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
Last Updated

April 22, 2014

Status Verified

April 1, 2014

Enrollment Period

1.6 years

First QC Date

April 15, 2014

Last Update Submit

April 17, 2014

Conditions

Impacted Third Molar Tooth

Keywords

third molar surgery, periodontal probing depth , flap design

Outcome Measures

Primary Outcomes (1)

  • change from baseline on the periodontal status of adjacent second molar

    6 months

Secondary Outcomes (1)

  • post surgical complication

    2 weeks

Study Arms (2)

test envelope

envelope flap

control, trapezodal

standard incision

Eligibility Criteria

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

You may qualify if:

  • third molar impaction
  • mild symptoms of pericoronitis

You may not qualify if:

  • systemic diseases
  • cigarettes smoking
  • history of irradiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuscan School of Dentistry

Siena, Siena, 53100, Italy

Location

Study Officials

  • nicola nb baldini, oral surgeon

    tuscan scool of dental medicine of florence and siena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
oral surgeon

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 22, 2014

Study Start

February 1, 2012

Primary Completion

September 1, 2013

Study Completion

March 1, 2014

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations

IT(1)