CompletedNot Applicable

The Impact of Surgical Technique on PDC

Sweden120 participantsStarted 2013-06

Plain-language 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.

Who can participate

Age range

8 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with diagnosis of uni- or bilateral palatally impacted canine/-s planned for surgical exposure at start of treatment of the impacted canines. In the bilateral impaction cases, the impacted canine in the more severe position according to the criteria (in Zone 2-4) proposed by Ericson and Kurol is included in the trial. * Dental development stage: maxillary DS2M1 and DS3M2 according to Björk * Pretreatment mesial position of the impacted canine in Zone 2-4, according to the criteria proposed by Ericson and Kurol, documented in panoramic radiographs. Exclusion Criteria: * Diseases affecting the somatic and/or craniofacial growth * Diseases not compatible with anaesthesia or surgery * Known neuropsychiatric diagnosis or documented learning disability * Problem to understand Swedish (patient and parent). Interpreter needed * Patients older than 16 years of age at the year of start of treatment * Ongoing orthodontic treatment * Patients with agenesis of the lateral incisor in the impacted side * Pretreatment mesial position of the impacted canine in Zone 5, according to the criteria proposed by Ericson and Kurol, documented in panoramic radiographs * Pretreatment vertical position of the impacted canine above the full length root of the central incisor on the same side, according to Fleming, PS. et al.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment success; the previous impacted canine is positioned in the dental arch

Timeframe: Within 3 years after surgery

Trial details

NCT IDNCT02186548

SponsorÖrebro County Council

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2021-01

View on ClinicalTrials.gov More Tooth, Impacted trials