Gingival Clefts and Orthodontic Movement

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Medical University of Vienna
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01402323
First received: July 25, 2011
Last updated: May 19, 2014
Last verified: July 2011
  Purpose

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
Endpoint Classification: Efficacy Study
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01402323     History of Changes
Other Study ID Numbers: EK Nr 105/2011
Study First Received: July 25, 2011
Last Updated: May 19, 2014
Health Authority: Austria: ethics committee

ClinicalTrials.gov processed this record on September 16, 2014