Gingival Clefts and Orthodontic Movement

May 19, 2014 updated by: Medical University of Vienna

A Prospective Split-mouth Designed Study on the Incidence of Gingival Clefts During Orthodontic Space Closure Into Recent or Healed Extraction Sockets.

Clefts or invaginations of the gingival tissue are a frequent finding during orthodontic space closure after extraction of a tooth. They occur in about 35% of the cases. Increased risk of developing a gingival cleft is given in the mandibular arch. A gingival invagination impairs aesthetics, orthodontic treatment and periodontal health. The aim of this prospective split-mouth designed observer blinded study is to evaluate possible differences between tooth movement in recent or in healed extraction sockets on incidence of gingival clefts. We hypothesize, that similar to the results originated from an animal study immediate movement in extraction sockets reduces incidence of gingival clefts during orthodontic space closure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

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

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Bernhard Gottlieb School of Dentistry, Medical University of Vienna
        • Contact:

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

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • extraction of both molars or premolars in the upper or lower jaw and orthodontic space closure

Exclusion Criteria:

  • periodontal status not allowing orthodontic treatment

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: early or late tooth extraction
Other: time point of tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of gingival clefts
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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

July 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (ESTIMATE)

July 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

July 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • EK Nr 105/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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