RecruitingNot ApplicableNCT06315348

Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

Effect on the Periodontal Phenotype of Flapless Alveolar Decortication and Augmentation During Orthodontic Treatment: A Randomized Clinical Trial


Sponsor

Universidad Complutense de Madrid

Enrollment

40 participants

Start Date

Apr 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 70 Years

Inclusion Criteria5

  • Patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain) looking for orthodontic therapy.
  • patients requiring maxillary and/or mandible orthodontic treatment;
  • patients with permanent dentition in stage 5 or 6 of the cervical vertebral maturation method as described by Baccetti et al. (2002);
  • minimal to moderate maxillary and/or mandibular anterior crowding at baseline (arch length discrepancy from 3-8 mm); and
  • adequate oral health (i.e. periodontal health, absence of periapical infections and untreated caries).

Exclusion Criteria6

  • subjects with periodontitis stage III or IV (Papapanou et al., 2018);
  • subjects with poor oral hygiene (represented as full-mouth plaque scores (FMPS) >25%);
  • ongoing chronic drug therapy influencing bone metabolism (e.g. steroids, immunosuppressors or antiresorptive drugs);
  • subjects with uncontrolled systemic diseases (e.g. diabetes);
  • pregnancy and
  • subjects not willing to comply with the study visits

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Interventions

PROCEDUREflapless 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.


Locations(1)

Faculty of Odontology, University Complutense Madrid

Madrid, Spain

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NCT06315348


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