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

Impacted Canine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02582645
• Other study ID #: 001_IMPACTED_CANINES
• Status: Recruiting
• Phase: N/A
• First received: October 14, 2015
• Last updated: October 20, 2015
• Start date: October 2015
• Est. completion date: September 2020

Study information

• Verified date: October 2015
• Source: University Hospital Olomouc
• Contact: Piotr S Fudalej, DDS, PhD
• Phone: 0041316322592
• Email: pfudalej[@]gmail.com
• Is FDA regulated: No
• Health authority: Czech Republic: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impacted Canine
• Tooth, Impacted

Intervention

Procedure:
• open window technique
palatally impacted canine will be exposed and left without traction for a maximum of 9 months
• 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

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent
Czech Republic	University Hospital Olomouc	Olomouc
Poland	Jagiellonian University	Krakow

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Olomouc	Jagiellonian University, University Hospital, Ghent

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total duration of treatment	The main study parameter will be the total duration of treatment. The beginning of the treatment will be at the moment of placement of fixed orthodontic appliances. In OWT group, the exposure of impacted canine will be performed prior to placement of fixed appliances. Nevertheless, the beginning of treatment will also be the moment of placement of fixed appliances. The end point of the study will be 6 months after completion of orthodontic treatment.	24 - 36 months	No
Secondary	Length of duration of surgical procedure		30 - 120 minutes	No
Secondary	Patient's perception of pain and recovery after surgery measured on 100 mm visual analog scale (VAS)	Patients will report pain/discomfort perception before surgery (baseline) and 1, 2, 3, 4, 5, 6, and 7 days after surgery.	7 days	No
Secondary	Quality of life and satisfaction with treatment measured with Oral Health Impact Profile (OHIP) -14 questionnaire	Quality of life and satisfaction with treatment will be assessed after completion of treatment orthodontic treatment (24-36 months after surgery). Patients will be asked to answer questions from Oral Health Impact Profile 14 questionnaire.	24-36 months	No
Secondary	Amount of root resorption of adjacent teeth		24-36 months	No
Secondary	Periodontal status of impacted canine and adjacent teeth - pocket depths, loss of clinical attachment, and gingival recession.	Pocket depth (in mm), loss of clinical attachment level (in mm), and presence of gingival recession (Yes/No) will be measured on impacted canine and adjacent teeth 6 months after completion of orthodontic treatment.	24-36 months	No
Secondary	Dentofacial esthetic outcome assessed on a photograph of the smile	6 months after completion of orthodontic treatment a photograph of smiling patient will be made. Using 100 mm visual analog scale (VAS) a panel of raters will judge esthetics of a smile.	24-36 months	No
Secondary	Occlusal outcome assessed with PAR index	A Peer Assessment Rating (PAR) index will be established on plaster models made immediately before any treatment and after completion of orthodontic treatment.	24-36 months	No
Secondary	Need for endodontic treatment of the impacted canine or adjacent lateral incisor		24-36 months	No