NCT02582645

Closed Window vs. Open Window Technique in Management of Palatally Impacted Canines

Closed Window Technique Versus Open Window Technique in Management of Palatally Impacted Canines. A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital Olomouc · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Rationale and objective: Two techniques for exposing palatally impacted canines are routinely used, the closed window technique (CWT) and the open window technique (OWT). To our knowledge, there is no evidence-based information that would suggest, which of the two techniques results in a better outcome. Our null hypothesis is that there is no difference in the outcome of exposed impacted maxillary canines after CWT or OWT. Study design: A randomized clinical multicentre trial with a two-group design. The randomization is by canine, not by patient. Study population: The case group consists of healthy persons of 11-17 years old who have unilateral palatally impacted canines. Intervention: One group will be treated with the CWT and the other group with the OWT. Main study parameters/endpoints: The main outcome measure will be the total duration of treatment (including also orthodontic treatment) with two techniques of management of impacted canines. The secondary outcome measures will be: (1) duration of surgical procedure, (2) patients perception of pain and recovery after surgery, (3) burden of care, (4) cost-effectiveness, (5) quality of life and satisfaction with treatment, (6) degree of root resorption of the lateral incisor, (7) periodontal status of impacted canine and adjacent teeth, (8) esthetic outcome, (9) need for endodontic treatment of the impacted canine or adjacent lateral incisor, (10) occlusal outcome (evaluated with PAR index). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The CWT and OWT are current treatment techniques. To our knowledge, there is no sound scientific information available on which to base a treatment decision. The burden of each treatment is for the patient the same. Routine pre- and post-treatment records will be taken. The extra burden for the patients participating in the trial will be records and questionnaires during treatment and long-term

Conditions

• Impacted Canine

Interventions

Type	Name	Description
PROCEDURE	open window technique	palatally impacted canine will be exposed and left without traction for a maximum of 9 months
PROCEDURE	closed window technique	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

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-09-01
• Completion: 2020-09-01
• First posted: 2015-10-21
• Last updated: 2015-10-21

Locations

3 sites across 3 countries: Belgium, Czechia, Poland