Gingival Clefts and Orthodontic Movement

Extraction Socket Clinical Trial

Official title:

A Prospective Split-mouth Designed Study on the Incidence of Gingival Clefts During Orthodontic Space Closure Into Recent or Healed Extraction Sockets.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01402323
• Other study ID #: EK Nr 105/2011
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2011
• Last updated: May 19, 2014
• Start date: July 2011

Study information

• Verified date: July 2011
• Source: Medical University of Vienna
• Contact: Kristina Bertl, DMD
• Phone: +43 664 5151194
• Email: kristina.bertl[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: ethics committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extraction Socket
• Gingival Clefts
• Orthodontic Movement

Intervention

Other:
• time point of tooth extraction

Locations

Country	Name	City	State
Austria	Bernhard Gottlieb School of Dentistry, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of gingival clefts		up to 6 months	No