NCT02582645

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

3.9 years

First QC Date

October 14, 2015

Last Update Submit

October 20, 2015

Conditions

Impacted Canine

Keywords

impactionimpacted caninepalatallyopen windowclosed windowmanagement

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Length of duration of surgical procedure

    30 - 120 minutes

  • Patient's perception of pain and recovery after surgery measured on 100 mm visual analog scale (VAS)

    7 days

  • Quality of life and satisfaction with treatment measured with Oral Health Impact Profile (OHIP) -14 questionnaire

    24-36 months

  • Amount of root resorption of adjacent teeth

    24-36 months

  • Periodontal status of impacted canine and adjacent teeth - pocket depths, loss of clinical attachment, and gingival recession.

    24-36 months

  • +3 more secondary outcomes

Study Arms (2)

OWT - open window technique

EXPERIMENTAL

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.

Procedure: open window technique

CWT - closed window technique

ACTIVE COMPARATOR

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).

Procedure: closed window technique

Interventions

open window techniquePROCEDURE

palatally impacted canine will be exposed and left without traction for a maximum of 9 months

Also known as: OWT
OWT - open window technique
closed window techniquePROCEDURE

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

Also known as: CWT
CWT - closed window technique

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Ghent

Ghent, Belgium

RECRUITING

University Hospital Olomouc

Olomouc, Olomouc, 77900, Czechia

RECRUITING

Jagiellonian University

Krakow, Poland

RECRUITING

Central Study Contacts

Piotr S Fudalej, DDS, PhD

CONTACT

0041316322592pfudalej@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 21, 2015

Study Start

October 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

CZ(1)PL(1)BE(1)