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Completed

NCT Number: NCT03406130

Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults

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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthodontic Procedure

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.

Piezocision surgery

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.

    Time frame: baseline, 1 year

  2. Alveolar crest parameters measurements (CBCT in millimeters)

    Time frame: baseline, 1 year

    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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • ACTEON Group

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 23, 2018
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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