Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients

NCT02590835 | Completed

• 1 other identifier: H2013-3
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tooth Overcrowding

Keywords

Adult patients; Patient demand for orthodontic treatment

Outcome Measures

Primary Outcomes (1)

• Overall treatment time measurement (in days)

  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.

  3 years

Secondary Outcomes (3)

• Root resorption parameters measurements (intrabuccal radiographic in millimeters)

  3 years

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

  3 years

• Patient-centered outcomes (VAS questionnaire)

  7 days

Study Arms (2)

Control group

ACTIVE COMPARATOR

Treated with conventional orthodontics

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

Test group

EXPERIMENTAL

subjected to piezo-assisted orthodontics

Procedure: Orthodontic procedures (for both groups : Control group and Test group); Procedure: Piezo-assisted orthodontics (only the Test group)

Interventions

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.

Control group; Test group

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.

Test group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. France LAMBERT: lead

Related Publications (1)

• Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.

  PMID: 27129491 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 29, 2015
• Study Start: February 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: October 1, 2015
• Last Updated: October 29, 2015

Record last verified: 2015-10