Localized Piezoelectric Alveolar Decortication With Customized Orthodontic Treatment in Adults: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Liege
- Enrollment
- 20
- Primary Endpoint
- Overall treatment time measurement (in days)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •altered bone metabolism (e.g., due to antiresorptive drug, steroid, or immunosuppressant use)
- •mental or motor disabilities; and 6) pregnancy.
Arms & Interventions
Insignia orthodontic treatment
Intervention: Orthodontic Procedure (Procedure)
Piezocision-assisted Insignia orthodontic treatment
Intervention: Orthodontic Procedure (Procedure)
Piezocision-assisted Insignia orthodontic treatment
Intervention: Piezocision surgery (Procedure)
Outcomes
Primary Outcomes
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
- 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)
- 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)
Investigators
Dr. France LAMBERT
Prof. France Lambert
University of Liege