Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-70
SponsorUniversidad Complutense de Madrid
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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);
Trial design
Treatments tested in this trial
- flapless alveolar decortication with augmentation
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universidad Complutense de Madrid
Lead sponsor
Osteology Foundation
Collaborator
Source ClinicalTrials.gov