Impacted CanineNCT02582645
Closed Window vs. Open Window Technique in Management of Palatally Impacted Canines
A study testing open window technique and closed window technique in people with Impacted Canine, run by University Hospital Olomouc at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Impacted Canine
- What is being tested?
- open window technique and closed window technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy boys and girls aged 11 to 17 years
- Unilaterally palatally impacted canine
- Canine axis > 100 to the midline measured on an orthopantomogram
Who cannot join
- Dental abnormalities (hyperdontia, hypodontia, etc.)
- Previous dental or facial trauma
- Congenital craniofacial disorder
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent
Guy De Pauw, DDS, PhD
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Olomouc
Olomouc, Olomouc, 77900
Piotr Fudalej, DDS, PhD
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University
Krakow
Bartlomiej Loster, DDS, PhD
About this study
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.
Read the 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
- Conditions
- Impacted Canine
- Being tested
- open window technique, closed window technique
- Keywords
- impaction, impacted canine, palatally, open window, closed window, management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open window techniqueProcedure or surgery
Also called OWT
palatally impacted canine will be exposed and left without traction for a maximum of 9 months
closed window techniqueProcedure or surgery
Also called CWT
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: closed window technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 - 36 months
Secondary outcomes (8)
Length of duration of surgical procedure
Measured: 30 - 120 minutes
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.
Measured: 7 days
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.
Measured: 24-36 months
Amount of root resorption of adjacent teeth
Measured: 24-36 months
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.
Measured: 24-36 months
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.
Measured: 24-36 months
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.
Measured: 24-36 months
Need for endodontic treatment of the impacted canine or adjacent lateral incisor
Measured: 24-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted CanineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, University Hospital, Ghent
- Responsible party
- Principal investigator, Piotr Fudalej, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582645
- Sponsor's protocol ID
- 001_IMPACTED_CANINES
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Window Technique Versus Open Window Technique in Management of Palatally Impacted Canines. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02582645
- Acronym / sponsor ID
- 001_IMPACTED_CANINES
- Conditions
- Impacted Canine
- Keywords
- impaction, impacted canine, palatally, open window, closed window, management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Jagiellonian University, University Hospital, Ghent
- Study start
- Oct 2015
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OWT - open window technique | Experimental | Procedure: open window techniqueIn this arm, a palatally impacted canine will be exposed surgically and left for max 9 months. No traction will be applied during this time. |
| CWT - closed window technique | Active comparator | Procedure: closed window techniqueIn 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). |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy boys and girls aged 11 to 17 years
- Unilaterally palatally impacted canine
- Canine axis > 100 to the midline measured on an orthopantomogram
Key exclusion criteria (3 listed)
- Dental abnormalities (hyperdontia, hypodontia, etc.)
- Previous dental or facial trauma
- Congenital craniofacial disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open window techniqueAlso: OWTpalatally impacted canine will be exposed and left without traction for a maximum of 9 months | Procedure or surgery | OWT - open window technique |
| closed window techniqueAlso: CWTpalatally 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 | Procedure or surgery | CWT - closed window technique |
Primary outcome
Total duration of treatment
Time frame: 24 - 36 months
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.
8 secondary outcomes
Length of duration of surgical procedure
Time frame: 30 - 120 minutes
Patient's perception of pain and recovery after surgery measured on 100 mm visual analog scale (VAS)
Time frame: 7 days
Quality of life and satisfaction with treatment measured with Oral Health Impact Profile (OHIP) -14 questionnaire
Time frame: 24-36 months
Amount of root resorption of adjacent teeth
Time frame: 24-36 months
Periodontal status of impacted canine and adjacent teeth - pocket depths, loss of clinical attachment, and gingival recession.
Time frame: 24-36 months
Dentofacial esthetic outcome assessed on a photograph of the smile
Time frame: 24-36 months
Occlusal outcome assessed with PAR index
Time frame: 24-36 months
Need for endodontic treatment of the impacted canine or adjacent lateral incisor
Time frame: 24-36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open window technique and closed window technique in people with Impacted Canine, run by University Hospital Olomouc at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Czechia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr S Fudalej, DDS, PhD (0041316322592, pfudalej@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration of treatment (time frame: 24 - 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.