Clinical trial Recruiting at 1 site Interventional Ages 16 to 70

Impact of flapless piezoincision on periodontal health during orthodontic treatment

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

Run by Universidad Complutense de Madrid · NCT06315348 · Data updated 2026-11-12

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.

More Maxillary Deficiency trials

Quick facts

Study typeInterventional
Ages16 Years to 70 Years
SexAll
Enrollment40 (estimated)
SponsorUniversidad Complutense de Madrid
Academic / other
Locations1 site (Madrid)
StatusRecruiting
StartedApril 20, 2024
Main results expectedOctober 2026
Study endsDecember 2026
Registry record updatedMay 8, 2026
Trial IDNCT06315348 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are non-growing patients with permanent dentition requiring orthodontic treatment for maxillary and/or mandibular issues.

Probably not a fit

Patients with advanced periodontitis or poor oral hygiene may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown promising results with piezoincision techniques, but this specific comparison of grafting types is novel.

Who can join: the full rules

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 it's running

  • Faculty of Odontology, University Complutense Madrid
    Madrid, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.