Gingival Clefts and Orthodontic Movement
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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. |
- 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: | September 2012 (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 |
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| Contact: Kristina Bertl, DMD | +43 664 5151194 | kristina.bertl@meduniwien.ac.at |
| 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 | |
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: | July 25, 2011 |
| Health Authority: | Austria: ethics committee |
ClinicalTrials.gov processed this record on May 23, 2013