Closed Window Technique Versus Open Window Technique in Management of Palatally Impacted Canines. A Randomized Clinical Trial
Sponsor study identifier
interventional
100
3 countries
3
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In this investigation the investigators would like to find out which of two commonly used techniques of management of palatally impacted canines: closed-window (CWT) or open-window (OWT), produces more favorable outcome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
October 14, 2015
Actual (reported)October 21, 2015
Actual (reported)September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Total duration of treatment
The main study parameter will be the total duration of treatment. The beginning of the treatment will be at the moment of placement of fixed orthodontic appliances. In OWT group, the exposure of impacted canine will be performed prior to placement of fixed appliances. Nevertheless, the beginning of treatment will also be the moment of placement of fixed appliances. The end point of the study will be 6 months after completion of orthodontic treatment.
24 - 36 months
Length of duration of surgical procedure
30 - 120 minutes
Patient's perception of pain and recovery after surgery measured on 100 mm visual analog scale (VAS)
7 days
Quality of life and satisfaction with treatment measured with Oral Health Impact Profile (OHIP) -14 questionnaire
24-36 months
Amount of root resorption of adjacent teeth
24-36 months
Periodontal status of impacted canine and adjacent teeth - pocket depths, loss of clinical attachment, and gingival recession.
24-36 months
In this arm, a palatally impacted canine will be exposed surgically and left for max 9 months. No traction will be applied during this time.
In this arm, a palatally impacted canine will be exposed surgically, an attachment will be bonded to the tooth and traction will be applied after healing period is complete (1-2 weeks).
palatally impacted canine will be exposed and left without traction for a maximum of 9 months
palatally impacted canine will be exposed, an attachment will be bonded, and then the canine will be covered with palatal tissue; traction of the canine will be initiated within 2 weeks following surgery
University Hospital Ghent
Ghent, Belgium
University Hospital Olomouc
Olomouc, Olomouc, 77900, Czechia
Jagiellonian University
Krakow, Poland
First Submitted
October 14, 2015
First Posted
October 21, 2015
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2019
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 21, 2015
Record last verified: 2015-10
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