Tooth OvercrowdingNCT02590835
Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients
A study testing Piezo-assisted orthodontics (only the Test group) in people with Tooth Overcrowding, run by Dr. France LAMBERT.
Trial summary
This study was designed as a randomized controlled clinical trial to compare conventional orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS group). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Overcrowding
- What is being tested?
- Piezo-assisted orthodontics (only the Test group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Oct 2015
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (completed growth)
- Maxillary and mandibular overcrowding
- Patient demand for orthodontic treatment
- Adequate dento-oral health
- ASA I and ASA II
- Compliance with clinic visits every 2 weeks
Who cannot join
- A need for tooth extraction
- A need for orthodontic temporary anchorage devices
- A history of periodontal disease
- Smokers
- Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
- Mental or motor disabilities
- Pregnancy
About this study
This study was designed as a randomized controlled clinical trial to compare conventional orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege University Hospital, Belgium who met the inclusion criteria were enrolled from January to October of 2013.
- Conditions
- Tooth Overcrowding
- Being tested
- Orthodontic procedures (for both groups : Control group and Test group), Piezo-assisted orthodontics (only the Test group)
- Keywords
- Adult patients, Patient demand for orthodontic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic procedures (for both groups : Control group and Test group)Procedure or surgery
Damon self-ligating systems (Ormco, Orange, Calif) were used for all patients. The patients were allowed to choose between clear or metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in copper-nickel-titanium Damon arch forms were placed. The subjects were recalled every two weeks, and the archwires were changed only when full bracket engagement was achieved. The sequence of archwires was as follows: 0.018-in, 0.014x0.025-in and 0.018x0.025-in copper nickel-titanium archwires for alignment; and 0.019x0.025-in stainless steel archwires for fine-tuning. Following the alignment steps, impressions were taken, and blinded orthodontic consultants validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and both fixed and removable retainers were placed.
Piezo-assisted orthodontics (only the Test group)Procedure or surgery
The piezocisionTM surgery was performed one week after orthodontic appliance placement . The patients received local anesthesia in both arches, and vertical interproximal micro-incisions were created below each interdental papilla. In cases of root proximity (i.e., less than 2 mm of interdental bone), this procedure was not applied. These incisions were kept to a minimum (varying from 5 mm to 8 mm). Next, using a vertical piezoelectric device, 5-mm long and 3-mm deep corticotomies were made, and no subsequent sutures were required needed (figure 1). The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intakes for one week. Anti-inflammatories were prohibited to avoid interference with the RAP. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Treated with conventional orthodontics Receives: Procedure: Orthodontic procedures (for both groups : Control group and Test group) |
| Test group | Experimental | subjected to piezo-assisted orthodontics Receives: Procedure: Orthodontic procedures (for both groups : Control group and Test group); Procedure: Piezo-assisted orthodontics (only the Test group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall treatment time measurement (in days)
Comparaison of the overall treatment time between the test group (piezocision group) and the control group will be performed. It will be evaluated by measuring the time (in days) between the placement and the debond of the orthodontic appliance. The hypothesis is that piezocision accelerate orthodontic tooth movement.
Measured: 3 years
Secondary outcomes (3)
Root resorption parameters measurements (intrabuccal radiographic in millimeters)
A comparaison of orthodontic parameters (root resorption) between the test group and the control group before and after orthodontic treatment will be performed. The root resorption will be measured in intrabuccal radiographic (millimeters) on the day of the placement of this appliance and at the debond.
Measured: 3 years
Comparaison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.
Measured: 3 years
Patient-centered outcomes (VAS questionnaire)
Satisfaction post treatment using a VAS questionnaire and analgesic consumption (milligrams of paracetamol) during 7 days after the placement of the orthodontic appliance.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth OvercrowdingStudies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. France LAMBERT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590835
- Sponsor's protocol ID
- H2013-3
- Status last verified
- Oct 2015
- First submitted
- 21 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
PubMed 27129491
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients
- ClinicalTrials.gov ID
- NCT02590835
- Acronym / sponsor ID
- H2013-3
- Conditions
- Tooth Overcrowding
- Keywords
- Adult patients, Patient demand for orthodontic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dr. France LAMBERTUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 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.
This study was designed as a randomized controlled clinical trial to compare conventional orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege University Hospital, Belgium who met the inclusion criteria were enrolled from January to October of 2013.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Orthodontic procedures (for both groups : Control group and Test group)Treated with conventional orthodontics |
| Test group | Experimental | Procedure: Orthodontic procedures (for both groups : Control group and Test group), Procedure: Piezo-assisted orthodontics (only the Test group)subjected to piezo-assisted orthodontics |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (completed growth)
- Maxillary and mandibular overcrowding
- Patient demand for orthodontic treatment
- Adequate dento-oral health
- ASA I and ASA II
Key exclusion criteria (7 listed)
- A need for tooth extraction
- A need for orthodontic temporary anchorage devices
- A history of periodontal disease
- Smokers
- Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
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 |
|---|---|---|
| Orthodontic procedures (for both groups : Control group and Test group)Damon self-ligating systems (Ormco, Orange, Calif) were used for all patients. The patients were allowed to choose between clear or metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in copper-nickel-titanium Damon arch forms were placed. The subjects were recalled every two weeks, and the archwires were changed only when full bracket engagement was achieved. The sequence of archwires was as follows: 0.018-in, 0.014x0.025-in and 0.018x0.025-in copper nickel-titanium archwires for alignment; and 0.019x0.025-in stainless steel archwires for fine-tuning. Following the alignment steps, impressions were taken, and blinded orthodontic consultants validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and both fixed and removable retainers were placed. | Procedure or surgery | Control group, Test group |
| Piezo-assisted orthodontics (only the Test group)The piezocisionTM surgery was performed one week after orthodontic appliance placement . The patients received local anesthesia in both arches, and vertical interproximal micro-incisions were created below each interdental papilla. In cases of root proximity (i.e., less than 2 mm of interdental bone), this procedure was not applied. These incisions were kept to a minimum (varying from 5 mm to 8 mm). Next, using a vertical piezoelectric device, 5-mm long and 3-mm deep corticotomies were made, and no subsequent sutures were required needed (figure 1). The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intakes for one week. Anti-inflammatories were prohibited to avoid interference with the RAP. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days. | Procedure or surgery | Test group |
Primary outcome
Overall treatment time measurement (in days)
Time frame: 3 years
Comparaison of the overall treatment time between the test group (piezocision group) and the control group will be performed. It will be evaluated by measuring the time (in days) between the placement and the debond of the orthodontic appliance. The hypothesis is that piezocision accelerate orthodontic tooth movement.
3 secondary outcomes
Root resorption parameters measurements (intrabuccal radiographic in millimeters)
Time frame: 3 years
Comparaison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.
Time frame: 3 years
Patient-centered outcomes (VAS questionnaire)
Time frame: 7 days
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 29 Oct 2015.
- Derived from this study: PubMed 27129491Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Piezo-assisted orthodontics (only the Test group) in people with Tooth Overcrowding, run by Dr. France LAMBERT.
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 6 inclusion and 7 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall treatment time measurement (in days) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590835, which also lists 1 linked publication.
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 29 Oct 2015.