Actively Recruiting

Phase Not Applicable
Age: 16Years - 70Years
All Genders
NCT06315348

Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

Led by Universidad Complutense de Madrid · Updated on 2026-05-08

40

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

Sponsors

U

Universidad Complutense de Madrid

Lead Sponsor

O

Osteology Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

Who Can Participate

Age: 16Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients requiring maxillary and/or mandible orthodontic treatment
  • Patients with permanent dentition in stage 5 or 6 of cervical vertebral maturation
  • Minimal to moderate maxillary and/or mandibular anterior crowding (3-8 mm arch length discrepancy)
  • Adequate oral health with no periodontal disease, periapical infections, or untreated caries
Not Eligible

You will not qualify if you...

  • Subjects with stage III or IV periodontitis
  • Subjects with poor oral hygiene (full-mouth plaque scores over 25%)
  • Ongoing chronic drug therapy affecting bone metabolism (e.g., steroids, immunosuppressors, antiresorptive drugs)
  • Subjects with uncontrolled systemic diseases such as diabetes
  • Pregnancy
  • Subjects unwilling to comply with study visits

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Trial Site Locations

Total: 1 location

1

Faculty of Odontology, University Complutense Madrid

Madrid, Spain, 28040

Actively Recruiting

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Research Team

E

Eduardo Montero, Prof

CONTACT

C

Conchita Martin, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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