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Completed

NCT Number: NCT02590835

Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients

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.

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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

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Orthodontic procedures (for both groups : Control group and Test group)

Procedure

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Root resorption parameters measurements (intrabuccal radiographic in millimeters)

    Time frame: 3 years

    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.

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

    Time frame: 3 years

  3. Patient-centered outcomes (VAS questionnaire)

    Time frame: 7 days

    Satisfaction post treatment using a VAS questionnaire and analgesic consumption (milligrams of paracetamol) during 7 days after the placement of the orthodontic appliance.

Sponsors and collaborators

Lead sponsor

Dr. France LAMBERT

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Oct 29, 2015
Registry last updated
Oct 29, 2015

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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