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Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

Study acronym: Piezo_Ortho
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Apr 2025 to Oct 2026
    • Study completion date: Apr 2025 to Dec 2026
    • Start date changed from estimate of Apr 2024 to Apr 20, 2024
    v4
  2. Minor Publication revisedv3
  3. Minor Eligibility criteria shortened, about 10 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06315348
Lead Sponsor Universidad Complutense de Madrid
Collaborators: Osteology Foundation
Conditions
(from sponsor)
Dental Malocclusion, Maxillary Deficiency
Related terms Malocclusion, Retrognathia
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov