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Gingival Clefts and Orthodontic Movement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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 Phase
Gingival Clefts Extraction Socket Orthodontic Movement Other: time point of tooth extraction Not Applicable

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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 ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT01402323

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Contact: Kristina Bertl, DMD +43 664 5151194

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Bernhard Gottlieb School of Dentistry, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Kristina Bertl, DMD    +43 664 51515194   
Sponsors and Collaborators
Medical University of Vienna
Layout table for additonal information Identifier: NCT01402323    
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