Clinical trial NCT02582645: Closed Window vs. Open Window Technique in Management of Palatally Impacted Canines
Official title: Closed Window Technique Versus Open Window Technique in Management of Palatally Impacted Canines. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impacted Canine
Keywords: impaction
impacted canine
palatally
open window
closed window
management
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
name: University Hospital, Ghent
First posted: 2015-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Healthy boys and girls aged 11 to 17 years
* Unilaterally palatally impacted canine
* Canine axis \> 100 to the midline measured on an orthopantomogram

Exclusion Criteria:

* Dental abnormalities (hyperdontia, hypodontia, etc.)
* Previous dental or facial trauma
* Congenital craniofacial disorder

Primary outcomes:
measure: Total duration of treatment
timeFrame: 24 - 36 months
Secondary outcomes:
measure: Length of duration of surgical procedure
timeFrame: 30 - 120 minutes
measure: Patient's perception of pain and recovery after surgery measured on 100 mm visual analog scale (VAS)
timeFrame: 7 days
measure: Quality of life and satisfaction with treatment measured with Oral Health Impact Profile (OHIP) -14 questionnaire
timeFrame: 24-36 months
measure: Amount of root resorption of adjacent teeth
timeFrame: 24-36 months
measure: Periodontal status of impacted canine and adjacent teeth - pocket depths, loss of clinical attachment, and gingival recession.
timeFrame: 24-36 months
measure: Dentofacial esthetic outcome assessed on a photograph of the smile
timeFrame: 24-36 months
measure: Occlusal outcome assessed with PAR index
timeFrame: 24-36 months
measure: Need for endodontic treatment of the impacted canine or adjacent lateral incisor
timeFrame: 24-36 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Krakow
country: Poland
facility: Jagiellonian University
Study officials:
References: