Clinical trial NCT03406130: Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults
Official title: Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Overcrowding
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: ACTEON Group
First posted: 2018-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall treatment time measurement (in days)
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.
timeFrame: baseline, 1 year
measure: Alveolar crest parameters measurements (CBCT in millimeters)
timeFrame: baseline, 1 year
measure: Comparison of radiographic parameters between the test group and the control group before (at baseline) and after orthodontic treatment (CBCT)
timeFrame: baseline, 1 year
measure: Comparison of Patient-centered outcomes (VAS questionnaire) between the test group and the control group before (at baseline) and after orthodontic treatment
timeFrame: baseline, 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Charavet 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.