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

University Hospital Olomouc

Status: Unknown

Conditions: Impacted Canine

Treatments: Procedure: closed window technique; Procedure: open window technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02582645

001_IMPACTED_CANINES

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

OWT - open window technique

Experimental group

Description:

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.

Treatment:

Procedure: open window technique

CWT - closed window technique

Active Comparator group

Description:

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).

Treatment:

Procedure: closed window technique