Gingival Clefts and Orthodontic Movement | NCT01402323

Studies
Gingival Clefts and Orthodontic Movement

NCT01402323

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

May 20, 2014Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Gingival Clefts
Extraction Socket
Orthodontic Movement

Interventions

time point of tooth extraction

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Jul 25, 2011

First Submission Date that Met QC Criteria

Jul 25, 2011

First Posted Date

Jul 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2014

Last Update Posted Date

May 20, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
early or late tooth extraction	Other		Other: time point of tooth extraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
time point of tooth extraction	Other		early or late tooth extraction

Measure	Description	Time Frame
incidence of gingival clefts		up to 6 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kristina Bertl, DMD	Contact	+43 664 5151194		kristina.bertl@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bernhard Gottlieb School of Dentistry, Medical University of Vienna	Recruiting	Vienna		1090	Austria