Palatally Impacted CaninesNCT01093352
Effect of Alveolar-decortication on Velocity of Tooth Movement
A study testing Alveolar-decortication. in people with Palatally Impacted Canines, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
The purpose of this pilot clinical trial is to evaluate whether alveolar-decortication has the potential to reduce orthodontic treatment time following surgical exposure of palatally impacted canines. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Palatally Impacted Canines
- What is being tested?
- Alveolar-decortication.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Feb 2010to 25 Oct 2017
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients at Birmingham Dental Hospital.
- Patients with a palatally impacted canine, awaiting surgical exposure.
- Patients with bilateral impacted canines may be included; in these cases both canines will be treated using the same surgical technique determined by allocation into either the test or control group.
- Informed consent gained.
Who cannot join
- History of periodontal disease.
- Radiographical evidence of pathology associated with the impacted canine.
- Patients already participating in a research study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Dentistry, University of Birmingham
Birmingham, B4 6NN
About this study
Official title: The Efficacy of Surgical Exposure With Alveolar-decortication vs. Conventional Surgical Exposure to Reduce Treatment Time for Orthodontic Alignment of Palatally Impacted Canines
The purpose of this pilot clinical trial is to evaluate whether alveolar-decortication has the potential to reduce orthodontic treatment time following surgical exposure of palatally impacted canines.
Read the detailed description
Purpose:
Upper permanent canines frequently become impacted (2%), which prevents their normal eruption (Brin et al, 1986. Ericson and Kurol, 1986). The upper canine may become impacted palatally (61%) or buccally (4.5%) (Stivaros and Mandall, 2000).
One of the treatment options for impacted canines is to surgically expose the canine tooth and to align it using orthodontic appliances. A bracket is attached to the tooth at the time of surgery. The tooth is then aligned using orthodontic forces.
Alveolar-decortication is also referred to as corticotomy-assisted orthodontics (Fischer, 2007). The technique involves exposure of alveolar bone and partial decortication of the cortical plates followed by primary flap closure.
It is believed that this alternative surgical technique reduces the time taken to orthodontically align teeth; previous case reports and preliminary studies report reductions by 28% to 80% in treatment time (Fischer, 2007. Wilcko et al, 2001).
No rigorous clinical trials have been conducted to evaluate the efficacy of alveolar-decortication to reduce orthodontic treatment times. We plan to evaluate this technique in patients with palatally impacted canines because a surgical procedure is necessary anyway to expose the tooth and the additional surgical trauma is minimal.
Aims and objectives:
This study aims to investigate the effect of alveolar-decortication in addition to surgical exposure, on the time taken to align palatally impacted canines. The alternative surgical technique will be compared to the conventional surgical exposure, by recording the time taken to subsequently align the tooth.
The objective is to determine whether the use of alveolar-decortication whilst exposing an impacted tooth, will lead to a reduction in the time required to align the tooth, and therefore a reduction in the overall treatment time.
Recruitment and consent:
30 orthodontic patients (n=15 per group), who are awaiting exposure and bonding of a palatally impacted canine tooth, will be selected from the waiting list at Birmingham Dental Hospital. Potential participants will be invited to take part in the study; they will be given verbal and written information. If they are happy to take part, written consent will be obtained. All patients recruited will be competent and capable of making the decision. For patients under 16 years of age, parental/legal guardian consent will be obtained. The patients will be able to withdraw from the study at any time, should they not wish to continue participating.
Methods:
Participants will be randomly allocated to either the control or test group, at the time of surgery.
Randomisation will use the method of randomly permuted blocks with variable block size. Enrolled participants will be assigned a study number at the time of surgery. The envelope with group assignment will be opened after completion of the surgical exposure (prior to wound closure). For subjects randomised to the test group, alveolar-decortication will then be carried out prior to wound closure. While the surgeon cannot be blinded for obvious reasons, group assignment will not be disclosed to the patient and will not be disclosed to the orthodontist.
At the time of surgery, 3 intra-oral photographs will be taken of the upper arch, including the exposed tooth.
Following surgery, the orthodontic treatment will be carried out in the normal way. At routine appointments, 3 intra-oral photographs will be taken of the upper arch, including the canine tooth. These photographs will be inserted into a computer programme, and a stereo-imaging technique will be used to construct a 3-D image, which will allow the velocity of tooth movement to be calculated.
Impressions will be taken of the upper arch during treatment, the resultant study models can also be used to calculate velocity of tooth movement. The distance between the tip of the canine tooth, to the line of the arch will be measured with callipers, at the time of surgery and also during routine orthodontic appointments.
Inclusion criteria:
Patients at Birmingham Dental Hospital. Patients with a palatally impacted canine, awaiting surgical exposure. Patients with bilateral impacted canines may be included, in these cases both canines will be treated using the same surgical technique determined by allocation into either the test or control group.
Informed consent gained.
Exclusion criteria:
History of periodontal disease. Radiographical evidence of pathology associated with the impacted canine. Patients already participating in a research study.
- Conditions
- Palatally Impacted Canines
- Being tested
- Alveolar-decortication.
- Keywords
- Alveolar-decortication, Corticotomy assisted orthodontics, Palatally impacted canine, Surgical exposure of canines, Velocity of tooth movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar-decortication.Procedure or surgery
Also called Alveolar-decortication, Corticotomy assisted orthodontics
Following surgical exposure of the impacted tooth, the surgeon will prepare small holes (perforations) and/or grooves in the cortical bone surrounding the exposed tooth as well as in the buccal bone.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Standard expose and bond. |
| Alveolar-decortication | Experimental | Following surgical exposure of the impacted canine, additional perforations will be made in the surrounding cortical bone prior to wound closure. Receives: Procedure: Alveolar-decortication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity of tooth movement
The velocity of movement of the canine tooth will be recorded, from the start (buried) position until it is in the line of the arch. Measurements will be taken at each orthodontic appointment, usually 6-8 weeks apart throughtout treatment.
Distance will be measured with the use of linear measurements, impressions and clinical photographs.
Measured: 6-8 weeks
Secondary outcomes (4)
Time for alignment
This will record the overall time for canine alignment, from its initial position to its final position when active orthodontic appliances are removed.
Measured: approx. 2 years.
Total orthodontic treatment time
This will record the overall time, from placement to removal of active orthodontic appliances.
Measured: approx. 2.5 years.
Duration of surgery
The duration of the surgical procedure in minutes, the time inbetween raising and closing the flap of gum tissue will be recorded.
Measured: 1 day
Adverse effects of surgery
Measured: approx. 2.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study start23 Feb 2010
- Primary completion1 Mar 2015
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatally Impacted CaninesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Alice Bussell, University of Birmingham
- Investigators
- Thomas Dietrich, DMD, MD, MPH, Principal investigator, School of Dentistry, University of Birmingham.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093352
- Sponsor's protocol ID
- 09/H1207/108
- Status last verified
- Oct 2018
- First submitted
- 18 Mar 2010
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Surgical Exposure With Alveolar-decortication vs. Conventional Surgical Exposure to Reduce Treatment Time for Orthodontic Alignment of Palatally Impacted Canines
- ClinicalTrials.gov ID
- NCT01093352
- Acronym / sponsor ID
- 09/H1207/108
- Conditions
- Palatally Impacted Canines
- Keywords
- Alveolar-decortication, Corticotomy assisted orthodontics, Palatally impacted canine, Surgical exposure of canines, Velocity of tooth movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 23 Feb 2010 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 25 Mar 2010 (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.
The purpose of this pilot clinical trial is to evaluate whether alveolar-decortication has the potential to reduce orthodontic treatment time following surgical exposure of palatally impacted canines.
Detailed description
Purpose:
Upper permanent canines frequently become impacted (2%), which prevents their normal eruption (Brin et al, 1986. Ericson and Kurol, 1986). The upper canine may become impacted palatally (61%) or buccally (4.5%) (Stivaros and Mandall, 2000).
One of the treatment options for impacted canines is to surgically expose the canine tooth and to align it using orthodontic appliances. A bracket is attached to the tooth at the time of surgery. The tooth is then aligned using orthodontic forces.
Alveolar-decortication is also referred to as corticotomy-assisted orthodontics (Fischer, 2007). The technique involves exposure of alveolar bone and partial decortication of the cortical plates followed by primary flap closure.
It is believed that this alternative surgical technique reduces the time taken to orthodontically align teeth; previous case reports and preliminary studies report reductions by 28% to 80% in treatment time (Fischer, 2007. Wilcko et al, 2001).
No rigorous clinical trials have been conducted to evaluate the efficacy of alveolar-decortication to reduce orthodontic treatment times. We plan to evaluate this technique in patients with palatally impacted canines because a surgical procedure is necessary anyway to expose the tooth and the additional surgical trauma is minimal.
Aims and objectives:
This study aims to investigate the effect of alveolar-decortication in addition to surgical exposure, on the time taken to align palatally impacted canines. The alternative surgical technique will be compared to the conventional surgical exposure, by recording the time taken to subsequently align the tooth.
The objective is to determine whether the use of alveolar-decortication whilst exposing an impacted tooth, will lead to a reduction in the time required to align the tooth, and therefore a reduction in the overall treatment time.
Recruitment and consent:
30 orthodontic patients (n=15 per group), who are awaiting exposure and bonding of a palatally impacted canine tooth, will be selected from the waiting list at Birmingham Dental Hospital. Potential participants will be invited to take part in the study; they will be given verbal and written information. If they are happy to take part, written consent will be obtained. All patients recruited will be competent and capable of making the decision. For patients under 16 years of age, parental/legal guardian consent will be obtained. The patients will be able to withdraw from the study at any time, should they not wish to continue participating.
Methods:
Participants will be randomly allocated to either the control or test group, at the time of surgery.
Randomisation will use the method of randomly permuted blocks with variable block size. Enrolled participants will be assigned a study number at the time of surgery. The envelope with group assignment will be opened after completion of the surgical exposure (prior to wound closure). For subjects randomised to the test group, alveolar-decortication will then be carried out prior to wound closure. While the surgeon cannot be blinded for obvious reasons, group assignment will not be disclosed to the patient and will not be disclosed to the orthodontist.
At the time of surgery, 3 intra-oral photographs will be taken of the upper arch, including the exposed tooth.
Following surgery, the orthodontic treatment will be carried out in the normal way. At routine appointments, 3 intra-oral photographs will be taken of the upper arch, including the canine tooth. These photographs will be inserted into a computer programme, and a stereo-imaging technique will be used to construct a 3-D image, which will allow the velocity of tooth movement to be calculated.
Impressions will be taken of the upper arch during treatment, the resultant study models can also be used to calculate velocity of tooth movement. The distance between the tip of the canine tooth, to the line of the arch will be measured with callipers, at the time of surgery and also during routine orthodontic appointments.
Inclusion criteria:
Patients at Birmingham Dental Hospital. Patients with a palatally impacted canine, awaiting surgical exposure. Patients with bilateral impacted canines may be included, in these cases both canines will be treated using the same surgical technique determined by allocation into either the test or control group.
Informed consent gained.
Exclusion criteria:
History of periodontal disease. Radiographical evidence of pathology associated with the impacted canine. Patients already participating in a research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Standard expose and bond. |
| Alveolar-decortication | Experimental | Procedure: Alveolar-decortication.Following surgical exposure of the impacted canine, additional perforations will be made in the surrounding cortical bone prior to wound closure. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients at Birmingham Dental Hospital.
- Patients with a palatally impacted canine, awaiting surgical exposure.
- Patients with bilateral impacted canines may be included; in these cases both canines will be treated using the same surgical technique determined by allocation into either the test or control group.
- Informed consent gained.
Key exclusion criteria (3 listed)
- History of periodontal disease.
- Radiographical evidence of pathology associated with the impacted canine.
- Patients already participating in a research study.
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 |
|---|---|---|
| Alveolar-decortication.Also: Alveolar-decortication, Corticotomy assisted orthodonticsFollowing surgical exposure of the impacted tooth, the surgeon will prepare small holes (perforations) and/or grooves in the cortical bone surrounding the exposed tooth as well as in the buccal bone. | Procedure or surgery | Alveolar-decortication |
Primary outcome
Velocity of tooth movement
Time frame: 6-8 weeks
The velocity of movement of the canine tooth will be recorded, from the start (buried) position until it is in the line of the arch. Measurements will be taken at each orthodontic appointment, usually 6-8 weeks apart throughtout treatment. Distance will be measured with the use of linear measurements, impressions and clinical photographs.
4 secondary outcomes
Time for alignment
Time frame: approx. 2 years.
Total orthodontic treatment time
Time frame: approx. 2.5 years.
Duration of surgery
Time frame: 1 day
Adverse effects of surgery
Time frame: approx. 2.5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Related trials for Palatally Impacted Canines
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.
Thomas Dietrich, DMD, MD, MPH principal investigator
School of Dentistry, University of Birmingham.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar-decortication. in people with Palatally Impacted Canines, run by University of Birmingham at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity of tooth movement (time frame: 6-8 weeks). 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 11 Oct 2018.