Impacted Canine Clinical Trial
Official title:
Closed Window Technique Versus Open Window Technique in Management of Palatally Impacted Canines. A Randomized Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05644678 -
Evaluation of the Periodontal Status After the Treatment of Palatally Impacted Canines Using Acceleration Procedures
|
N/A |