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Gingival Clefts and Orthodontic Movement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Medical University of Vienna.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: July 26, 2011
Last Update Posted: May 20, 2014
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.
Information provided by:
Medical University of Vienna
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 Intervention
Gingival Clefts Extraction Socket Orthodontic Movement Other: time point of tooth extraction

Study Type: Interventional
Study Design: 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.

Further study details as provided by Medical University of Vienna:

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

Estimated Enrollment: 25
Study Start Date: July 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
early or late tooth extraction Other: time point of tooth extraction


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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

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

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
  More Information

ClinicalTrials.gov Identifier: NCT01402323     History of Changes
Other Study ID Numbers: EK Nr 105/2011
First Submitted: July 25, 2011
First Posted: July 26, 2011
Last Update Posted: May 20, 2014
Last Verified: July 2011