Tooth OvercrowdingNCT03406130
Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults
A study testing Orthodontic Procedure and Piezocision surgery in people with Tooth Overcrowding, run by University of Liege.
Trial summary
The aim of the present randomized controlled clinical trial will compare Insignia orthodontic treatment to piezocision-assisted Insignia orthodontics in adult patients. The primary objective will be to determine the efficacy of piezocision-accelerated orthodontic treatment by measuring the treatment duration in both… 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?
- Orthodontic Procedure and Piezocision surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring maxillary and mandible orthodontic treatment (both arches)
- Adult patients with completed growth based on the cervical vertebral maturation method as described by Baccetti et al. (Baccetti et al. 2002)
- Minimal to moderate maxillary and mandibular anterior crowding at baseline (irregularity index <6;(Little 1975));
- American Society of Anesthesiology I or II (I = nor- mal healthy patient; II = patient with mild systemic disease);
- Adequate dento-oral health (i.e., the absence of periodontal diseases, periapical infection, or untreated caries).
Who cannot join
- controlled periodontitis with a loss of alveolar support >10%
- gingival recession >2 mm
- smokers
- altered bone metabolism (e.g., due to antiresorptive drug, steroid, or immunosuppressant use)
- mental or motor disabilities; and 6) pregnancy.
About this study
Official title: Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults: A Randomized Controlled Trial
The aim of the present randomized controlled clinical trial will compare Insignia orthodontic treatment to piezocision-assisted Insignia orthodontics in adult patients. The primary objective will be to determine the efficacy of piezocision-accelerated orthodontic treatment by measuring the treatment duration in both groups. The secondary objectives will be to compare periodontal health, alveolar crest changes, bone and gingival healing, analgesic intake and patient-centered outcomes between the 2 groups.
- Conditions
- Tooth Overcrowding
- Being tested
- Orthodontic Procedure, Piezocision surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic ProcedureProcedure or surgery
Damon self-ligating systems (Ormco) were used for all patients. The patients were allowed to choose between clear and 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 returned every 2 wk, and the archwires were changed only when full bracket engagement were achieved. The sequence of archwires was the following: 0.018-in., 0.014 × 0.025-in., and 0.018 × 0.025-in. copper nickel-titanium archwires were used for alignment, while 0.019 × 0.025-in. stainless-steel archwires were used for fine-tuning. Following the alignment steps, impressions were taken, and a blinded senior orthodontist validated appliance removal or provided advice regarding further adjustments.
Alginate impressions were taken after the removal of the appliances, and fixed and removable retainers were placed.
Piezocision surgeryProcedure or surgery
The piezocision surgery was performed 1 week after orthodontic appliance placement. The surgical protocol was performed as described by Dibart and al. (Dibart et al. 2009). However, to avoid bias, hard and soft tissue augmentations were not considered. The patients received local anesthesia in both arches; vertical interproximal microincisions were created below each interdental papilla. In cases of root proximity (i.e., <2 mm of interdental bone), this procedure was not performed. These incisions were kept to a minimum (varying from 5 to 8 mm). Next, with a vertical piezoelectric device, 5-mm-long and 3-mm-deep corticotomies were made, and no subsequent sutures were required. The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intake for 1 wk. Anti-inflammatories were prohibited to avoid interference with the RAP.
| Study group | Role | What they receive |
|---|---|---|
| Insignia orthodontic treatment | Active comparator | Not described Receives: Procedure: Orthodontic Procedure |
| Piezocision-assisted Insignia orthodontic treatment | Experimental | Not described Receives: Procedure: Orthodontic Procedure; Procedure: Piezocision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall treatment time measurement (in days)
The cumulative times from bracket placement to each archwire change and to orthodontic appliance removal will be recorded in days.
Measured: 1 year
Secondary outcomes (4)
Comparison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.
Measured: baseline, 1 year
Alveolar crest parameters measurements (CBCT in millimeters)
The patients will be undergone baseline and post- treatment CBCT. The thick- ness of the buccal alveolar plate and the buccolingual thickness of the alveolar crest will be measured.
Measured: baseline, 1 year
Comparison of radiographic parameters between the test group and the control group before (at baseline) and after orthodontic treatment (CBCT)
Measured: baseline, 1 year
Comparison of Patient-centered outcomes (VAS questionnaire) between the test group and the control group before (at baseline) and after orthodontic treatment
Measured: baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startAug 2016
- Primary completionNov 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- ACTEON Group
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406130
- Sponsor's protocol ID
- P2016-1 WP1
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Charavet C, Lecloux G, Jackers N, Maes N, Lambert F. Patient-reported outcomes measures (PROMs) following a piezocision-assisted versus conventional orthodontic treatments: a randomized controlled trial in adults. Clin Oral Investig. 2019 Dec;23(12):4355-4363. doi: 10.1007/s00784-019-02887-z. Epub 2019 Apr 6.
PubMed 30955096Charavet C, Lecloux G, Jackers N, Albert A, Lambert F. Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults. Eur J Orthod. 2019 Sep 21;41(5):495-501. doi: 10.1093/ejo/cjy082.
PubMed 30649257
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03406130
- Acronym / sponsor ID
- P2016-1 WP1
- Conditions
- Tooth Overcrowding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- ACTEON Group
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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 aim of the present randomized controlled clinical trial will compare Insignia orthodontic treatment to piezocision-assisted Insignia orthodontics in adult patients. The primary objective will be to determine the efficacy of piezocision-accelerated orthodontic treatment by measuring the treatment duration in both groups. The secondary objectives will be to compare periodontal health, alveolar crest changes, bone and gingival healing, analgesic intake and patient-centered outcomes between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insignia orthodontic treatment | Active comparator | Procedure: Orthodontic Procedure |
| Piezocision-assisted Insignia orthodontic treatment | Experimental | Procedure: Orthodontic Procedure, Procedure: Piezocision surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients requiring maxillary and mandible orthodontic treatment (both arches)
- Adult patients with completed growth based on the cervical vertebral maturation method as described by Baccetti et al. (Baccetti et al. 2002)
- Minimal to moderate maxillary and mandibular anterior crowding at baseline (irregularity index <6;(Little 1975));
- American Society of Anesthesiology I or II (I = nor- mal healthy patient; II = patient with mild systemic disease);
- Adequate dento-oral health (i.e., the absence of periodontal diseases, periapical infection, or untreated caries).
Key exclusion criteria (5 listed)
- controlled periodontitis with a loss of alveolar support >10%
- gingival recession >2 mm
- smokers
- altered bone metabolism (e.g., due to antiresorptive drug, steroid, or immunosuppressant use)
- mental or motor disabilities; and 6) pregnancy.
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 ProcedureDamon self-ligating systems (Ormco) were used for all patients. The patients were allowed to choose between clear and 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 returned every 2 wk, and the archwires were changed only when full bracket engagement were achieved. The sequence of archwires was the following: 0.018-in., 0.014 × 0.025-in., and 0.018 × 0.025-in. copper nickel-titanium archwires were used for alignment, while 0.019 × 0.025-in. stainless-steel archwires were used for fine-tuning. Following the alignment steps, impressions were taken, and a blinded senior orthodontist validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and fixed and removable retainers were placed. | Procedure or surgery | Insignia orthodontic treatment, Piezocision-assisted Insignia orthodontic treatment |
| Piezocision surgeryThe piezocision surgery was performed 1 week after orthodontic appliance placement. The surgical protocol was performed as described by Dibart and al. (Dibart et al. 2009). However, to avoid bias, hard and soft tissue augmentations were not considered. The patients received local anesthesia in both arches; vertical interproximal microincisions were created below each interdental papilla. In cases of root proximity (i.e., <2 mm of interdental bone), this procedure was not performed. These incisions were kept to a minimum (varying from 5 to 8 mm). Next, with a vertical piezoelectric device, 5-mm-long and 3-mm-deep corticotomies were made, and no subsequent sutures were required. The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intake for 1 wk. Anti-inflammatories were prohibited to avoid interference with the RAP. | Procedure or surgery | Piezocision-assisted Insignia orthodontic treatment |
Primary outcome
Overall treatment time measurement (in days)
Time frame: 1 year
The cumulative times from bracket placement to each archwire change and to orthodontic appliance removal will be recorded in days.
4 secondary outcomes
Comparison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.
Time frame: baseline, 1 year
Alveolar crest parameters measurements (CBCT in millimeters)
Time frame: baseline, 1 year
Comparison of radiographic parameters between the test group and the control group before (at baseline) and after orthodontic treatment (CBCT)
Time frame: baseline, 1 year
Comparison of Patient-centered outcomes (VAS questionnaire) between the test group and the control group before (at baseline) and after orthodontic treatment
Time frame: baseline, 1 year
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 23 Jan 2018.
- Derived from this study: PubMed 30955096Charavet C, Lecloux G, Jackers N, Maes N, Lambert F. Patient-reported outcomes measures (PROMs) following a piezocision-assisted versus conventional orthodontic treatments: a randomized controlled trial in adults. Clin Oral Investig. 2019 Dec;23(12):4355-4363. doi: 10.1007/s00784-019-02887-z. Epub 2019 Apr 6.
- Derived from this study: PubMed 30649257Charavet C, Lecloux G, Jackers N, Albert A, Lambert F. Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults. Eur J Orthod. 2019 Sep 21;41(5):495-501. doi: 10.1093/ejo/cjy082.
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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 Orthodontic Procedure and Piezocision surgery in people with Tooth Overcrowding, run by University of Liege.
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 5 inclusion and 5 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 23 Jan 2018. 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: 1 year). 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 NCT03406130, which also lists 2 linked publications.
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 23 Jan 2018.