CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 target
Drug / intervention
Closed surgical technique +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT02186548
NCT02186548N/ACompleted

Closed Versus Open Surgical Exposure of Palatally Displaced Canines (PDC); Treatment and Treatment Outcome Including Aspects of Cost-benefit and Patients´Perceptions. A Multicenter Prospective Randomized Clinical Trial

Örebro County Council·interventional·Posted Jul 10, 2014·Updated Sep 10, 2021

In Brief

A clinical study evaluating Closed surgical technique and Open surgical technique for Tooth, Impacted. Completed, enrolled 120 participants across 3 sites.

Detailed Summary

Permanent canines in the maxilla usually erupt into the mouth at 11-12 years of age. In approximately 2% of the Swedish population they fail to erupt, and are then referred to as impacted. One severe complication of impacted maxillary canines is damage (root resorption) to the roots of adjacent teeth. The root resorption may be so severe that neighboring teeth are lost. If the impaction is detected early (at 9-10 years of age), the recommended treatment is to extract the deciduous canine, to help the permanent canine to resolve its unfavorable position. If there is no improvement of the position of the canine 1 year after the extraction, surgical and orthodontic treatment is indicated. Surgical exposure is followed by orthodontic treatment with fixed appliance for 2 to 3 years to bring the canine into correct position. Two different main principles of surgical exposure in palatally impacted maxillary permanent canines are the so called closed versus open surgical techniques. Closed technique involves surgically uncovering of the canine with a mucoperiosteal flap dissected off the bone. The bone covering the canine is being removed and an attachment with a chain is bonded to the tooth. The flap is repositioned and sutured back with the chain above the mucosa. Shortly after the surgery, orthodontic force is applied via the chain. The canine is orthodontically moved beneath the palatal mucosa by forced eruption. Open technique involves surgically uncovering of the canine, removing a window of tissue around it and placing pack to cover the exposed area. Then the treatment approaches vary depending on whether the attachment with a chain is bonded to the exposed tooth at surgery or if spontaneous eruption of the palatally impacted canine is expected postsurgically. In both alternatives orthodontic force is applied via the chain and the canine is orthodontically moved above the mucosa. These two techniques of surgical exposure of palatally impacted canines seem to be the two routinely used in Sweden. The purposes of this study are to examine, describe and compare the treatment outcomes in regard to success and duration of treatment, complications, side effects, cost-benefit aspects and patients´ perceptions in closed versus open surgical exposure techniques, in cases with palatally impacted canines. The objective is to test the null hypothesis that there are no differences in the above outcomes between open or closed surgical exposure of palatally impacted canines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTooth, Impacted
CountriesSweden

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 10, 2014
Enrollment StartJun 1, 2013
Primary CompletionJan 1, 2021
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 12.0 years ago

Interventions

Closed surgical techniqueprocedure

* Surgically uncovering of the impacted canine with a mucoperiosteal flap dissected off the bone * The bone covering the canine is being removed * Attachment with a chain is bonded to the exposed tooth * The palatal flap is repositioned and sutured back with the chain above the mucosa. Shortly after the surgery * The canine is orthodontically moved beneath the palatal mucosa

Open surgical techniqueprocedure

* Surgically uncovering of the impacted canine, removing a window of tissue from around the tooth * Pack/filling material is applied on the tooth * Spontaneous eruption of the palatally impacted canine is allowed expected * The canine is orthodontically moved above the mucosa