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Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults

Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03406130
Enrollment
20
Registered
2018-01-23
Start date
2016-08-31
Completion date
2017-12-31
Last updated
2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Overcrowding

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.

Interventions

PROCEDUREOrthodontic Procedure

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.

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.

Sponsors

ACTEON Group
CollaboratorINDUSTRY
University of Liege
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall treatment time measurement (in days)1 yearThe cumulative times from bracket placement to each archwire change and to orthodontic appliance removal will be recorded in days.

Secondary

MeasureTime frameDescription
Comparison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.baseline, 1 year
Alveolar crest parameters measurements (CBCT in millimeters)baseline, 1 yearThe 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.
Comparison of radiographic parameters between the test group and the control group before (at baseline) and after orthodontic treatment (CBCT)baseline, 1 year
Comparison of Patient-centered outcomes (VAS questionnaire) between the test group and the control group before (at baseline) and after orthodontic treatmentbaseline, 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026