MedTrace Logo

Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

NCT06315348 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Dental Malocclusion
  • Maxillary Deficiency

Interventions

PROCEDURE

flapless alveolar decortication with augmentation

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. Piezocisions will be performed using a piezoelectric device.

Sponsors & Collaborators

  • Osteology Foundation

    collaborator OTHER

  • Universidad Complutense de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06315348 on ClinicalTrials.gov