Effect of Alveolar-decortication on Velocity of Tooth Movement

October 10, 2018 updated by: Mary Alice Bussell, University of Birmingham

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B4 6NN
        • School of Dentistry, University of Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard
Standard expose and bond.
Experimental: Alveolar-decortication
Following surgical exposure of the impacted canine, additional perforations will be made in the surrounding cortical bone prior to wound closure.
Procedure: Alveolar-decortication.
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.
Other Names:
  • Alveolar-decortication
  • Corticotomy assisted orthodontics

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6-8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time for alignment
Time Frame: approx. 2 years.
This will record the overall time for canine alignment, from its initial position to its final position when active orthodontic appliances are removed.
approx. 2 years.
Total orthodontic treatment time
Time Frame: approx. 2.5 years.
This will record the overall time, from placement to removal of active orthodontic appliances.
approx. 2.5 years.
Duration of surgery
Time Frame: 1 day
The duration of the surgical procedure in minutes, the time inbetween raising and closing the flap of gum tissue will be recorded.
1 day
Adverse effects of surgery
Time Frame: approx. 2.5 years.
approx. 2.5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Dietrich, DMD, MD, MPH, School of Dentistry, University of Birmingham.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09/H1207/108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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