Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults

Not Applicable

Completed

• Conditions: Tooth Overcrowding
• Interventions: Procedure: Orthodontic Procedure; Procedure: Piezocision surgery

• Registration Number: NCT03406130
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2016-11
• Study Completion: 2017-12
• Status Verified: 2018-01
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-19
• Last Update Submitted: 2018-01-19
• Study First Posted: 2018-01-23
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piezocision-assisted Insignia orthodontic treatment	Orthodontic Procedure	-
Insignia orthodontic treatment	Orthodontic Procedure	-
Piezocision-assisted Insignia orthodontic treatment	Piezocision surgery	-

Primary Outcome Measures

Name	Time	Method
Overall treatment time measurement (in days)	1 year	The cumulative times from bracket placement to each archwire change and to orthodontic appliance removal will be recorded in days.

Secondary Outcome Measures

Name	Time	Method
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 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.
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 treatment	baseline, 1 year