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Gingival Clefts and Orthodontic Movement

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ClinicalTrials.gov Identifier: NCT01402323
Recruitment Status : Unknown
Verified July 2011 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : July 26, 2011
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment
Gingival Clefts Extraction Socket Orthodontic Movement Other: time point of tooth extraction

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Split-mouth Designed Study on the Incidence of Gingival Clefts During Orthodontic Space Closure Into Recent or Healed Extraction Sockets.
Study Start Date : July 2011
Estimated Primary Completion Date : December 2015

Arm Intervention/treatment
early or late tooth extraction Other: time point of tooth extraction



Primary Outcome Measures :
  1. incidence of gingival clefts [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402323


Contacts
Contact: Kristina Bertl, DMD +43 664 5151194 kristina.bertl@meduniwien.ac.at

Locations
Austria
Bernhard Gottlieb School of Dentistry, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Kristina Bertl, DMD    +43 664 51515194    kristina.bertl@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

ClinicalTrials.gov Identifier: NCT01402323     History of Changes
Other Study ID Numbers: EK Nr 105/2011
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: July 2011