Impact of flapless piezoincision on periodontal health during orthodontic treatment
Effect on the Periodontal Phenotype of Flapless Alveolar Decortication and Augmentation During Orthodontic Treatment: A Randomized Clinical Trial
This study is testing if a new technique for orthodontic treatment without cutting the gums can improve gum health better than two types of grafting in adults with dental issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06315348 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of flapless piezoincision-assisted orthodontics with two different types of grafting: soft tissue grafting and bone grafting. The study will involve non-growing patients requiring orthodontic treatment for dental malocclusion and maxillary deficiency. Participants will undergo a series of assessments, including imaging and periodontal examinations, to evaluate changes in hard and soft tissues. The trial is designed as a single-blind, parallel group randomized controlled trial to ensure objective measurement of outcomes.
Who should consider this trial
Good fit: Ideal candidates are non-growing patients with permanent dentition requiring orthodontic treatment for maxillary and/or mandibular issues.
Not a fit: Patients with advanced periodontitis or poor oral hygiene may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved periodontal health and stability of orthodontic treatment outcomes for patients.
How similar studies have performed: Previous studies have shown promising results with piezoincision techniques, but this specific comparison of grafting types is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madrid
- Faculty of Odontology, University Complutense Madrid — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Eduardo Montero, Prof
- Email: eduardomonterosolis@ucm.es
- Phone: +34 91 3941901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.