Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

Recruiting now · Not applicable

Conditions studied: Dental Malocclusion, Maxillary Deficiency

In brief

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.

Key facts

Study ID

NCT06315348

Run by

Universidad Complutense de Madrid

People needed

40

Starts

2024-04-20

Expected to finish

2026-12-01

Last updated by the study team

2026-05-08

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain) looking for orthodontic therapy.
• The inclusion criteria will be as follows:
• 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).

You may not qualify if…

• 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

Where it is running

• Faculty of Odontology, University Complutense Madrid — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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