NCT06315348 Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment
| NCT ID | NCT06315348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Complutense de Madrid |
| Condition | Dental Malocclusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-20 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-04-20 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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). Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06315348 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 70 Years, studying Dental Malocclusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06315348 currently recruiting?
Yes, NCT06315348 is actively recruiting participants. Contact the research team at eduardomonterosolis@ucm.es for enrollment information.
Where is the NCT06315348 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06315348 clinical trial?
NCT06315348 is sponsored by Universidad Complutense de Madrid. The trial plans to enroll 40 participants.