Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial.
C Charavet, G Lecloux, A Bruwier...
https://pubmed.ncbi.nlm.nih.gov/27129491Actively Recruiting
Led by Universidad Complutense de Madrid · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
U
Universidad Complutense de Madrid
Lead Sponsor
O
Osteology Foundation
Collaborating Sponsor
Researchers are evaluating the effects of piezocision-assisted orthodontics combined with either soft tissue grafting or bone grafting in patients who are no longer growing. This randomized clinical trial aims to compare how these two surgical methods impact the hard and soft tissues around the teeth, particularly focusing on the periodontal phenotype and the stability of orthodontic treatment outcomes. The study also investigates treatment duration, tooth movement rates, root resorption, periodontal health, bone level changes, and patient-reported outcomes. Participants will receive orthodontic treatment with clear or metal brackets followed by one of two surgical interventions performed one week after appliance placement. One group will receive a volume-stable collagen matrix as a soft tissue graft, while the other group will receive a bone graft with a bovine xenograft covered by a native collagen membrane. Piezocision surgery involves small corticotomy cuts between tooth roots to accelerate tooth movement. After surgery, orthodontic treatment continues with regular archwire changes and follow-up visits. Throughout the study, participants will undergo extensive evaluations including scans, x-rays, periodontal examinations, and imaging to measure tissue thickness and blood flow. Monthly intraoral scans will monitor treatment progress, and patient questionnaires will capture pain levels and satisfaction. Researchers will analyze changes in tissue contours, bone and soft tissue thickness, periodontal health, orthodontic measurements, and adverse events over six months. The study expects to enroll about 40 patients and follows them through the complete orthodontic treatment period with detailed data collection and monitoring.
CONDITIONS
Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility assessment
Duration - 1 to 2 weeks
Participants undergo initial orthodontic and periodontal assessments including imaging, periodontal exams, and soft tissue measurements before any treatment begins.
1 visit (in-person) for baseline scans, x-rays, photographs, and periodontal measurements
Duration - 1 week between appliance placement and surgery
Participants receive orthodontic appliance placement followed one week later by flapless piezocision surgical intervention with either soft tissue grafting or bone grafting as randomized.
1 visit for appliance placement and 1 visit for surgery (both in-person)
Duration - Approximately 6 months
Participants undergo orthodontic treatment with periodic archwire adjustments every two weeks, starting immediately after surgery and continuing for approximately 6 months.
Biweekly visits for archwire changes and orthodontic adjustments for up to 6 months
Duration - 6 months concurrent with active treatment
Participants have monthly intraoral scans and periodontal evaluations to monitor treatment progress and periodontal health.
Monthly visits for intraoral scanning and periodontal assessments during treatment
Duration - 1 day
At the end of the treatment period, participants undergo final clinical evaluations including intraoral scans, periodontal charting, and assessment of soft tissue and bone changes before removal of orthodontic appliances.
1 visit (in-person) for final assessments and appliance removal
Total: 1 location
1
Faculty of Odontology, University Complutense Madrid
Madrid, Spain, 28040
Actively Recruiting
E
Eduardo Montero, Prof
C
Conchita Martin, Prof
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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C Charavet, G Lecloux, A Bruwier...
https://pubmed.ncbi.nlm.nih.gov/27129491