Clinical Trial

Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

Study acronym: Piezo_Ortho
Recruiting
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Summary
Research Question While the reduction in treatment times and the patient satisfaction after periodontally accelerated osteogenic orthodontics (PAOO) are well sustained in the scientific literature, there is still controversy regarding if grafting leads to i) change of the periodontal phenotype and ii) greater stability of post-orthodontic treatment outcomes, highlighting the need of controlled clinical trials. Aims of the Project The aim of this randomized clinical trial (RCT) is to compare piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane, in orthodontic non-growing patients. The primary aim will be to determine the impact of this surgical protocol on the hard and soft tissue changes occurring on the buccal aspect of the dentition. Secondary objectives will include the assessment of the comparative impact on treatment duration, rate of tooth movements, presence of root resorption, periodontal parameters, bone level changes and patient-reported outcome measures (PROMs) between the two groups.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-03-11; most recent amendment 2026-05-04.
Trial Details
NCT Number NCT06315348
Lead Sponsor Universidad Complutense de Madrid
Collaborators: Osteology Foundation
Conditions Dental Malocclusion, Maxillary Deficiency
Enrollment 40 participants
Start Date 2024-04-20
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-08