Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients

NCT ID: NCT02590835

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Treated with conventional orthodontics

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Test group

subjected to piezo-assisted orthodontics

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Intervention Type: 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.

Interventions

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

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.

Intervention Type: PROCEDURE

Piezo-assisted orthodontics (only the Test group)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. France LAMBERT

OTHER

Sponsor Role: lead

Responsible Party

Dr. France LAMBERT

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 27129491 (View on PubMed)

Other Identifiers

H2013-3

Identifier Type: -

Identifier Source: org_study_id