Actively Recruiting

Phase Not Applicable
Age: 16Years - 70Years
All Genders
ID06315348

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

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

40

Participants Needed

1

Research Sites

8 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

Researchers are evaluating the effects of piezocision-assisted orthodontics combined with either soft tissue grafting or bone grafting in patients who are no longer growing. This randomized clinical trial aims to compare how these two surgical methods impact the hard and soft tissues around the teeth, particularly focusing on the periodontal phenotype and the stability of orthodontic treatment outcomes. The study also investigates treatment duration, tooth movement rates, root resorption, periodontal health, bone level changes, and patient-reported outcomes. Participants will receive orthodontic treatment with clear or metal brackets followed by one of two surgical interventions performed one week after appliance placement. One group will receive a volume-stable collagen matrix as a soft tissue graft, while the other group will receive a bone graft with a bovine xenograft covered by a native collagen membrane. Piezocision surgery involves small corticotomy cuts between tooth roots to accelerate tooth movement. After surgery, orthodontic treatment continues with regular archwire changes and follow-up visits. Throughout the study, participants will undergo extensive evaluations including scans, x-rays, periodontal examinations, and imaging to measure tissue thickness and blood flow. Monthly intraoral scans will monitor treatment progress, and patient questionnaires will capture pain levels and satisfaction. Researchers will analyze changes in tissue contours, bone and soft tissue thickness, periodontal health, orthodontic measurements, and adverse events over six months. The study expects to enroll about 40 patients and follows them through the complete orthodontic treatment period with detailed data collection and monitoring.

CONDITIONS

Brief 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 needing orthodontic treatment for the upper and/or lower jaw
  • Patients with permanent teeth and completed growth stage as defined by cervical vertebral maturation
  • Mild to moderate crowding of teeth (3-8 mm) at the start of treatment
  • Good oral health with no untreated cavities or infections
Not Eligible

You will not qualify if you...

  • Having severe periodontitis (stage III or IV)
  • Poor oral hygiene with plaque scores above 25%
  • Taking medications that affect bone metabolism such as steroids or immunosuppressants
  • Having uncontrolled systemic diseases like diabetes
  • Being pregnant
  • Unwillingness to follow study visit schedules

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility assessment

Baseline Pretreatment Assessments

Duration - 1 to 2 weeks

Participants undergo initial orthodontic and periodontal assessments including imaging, periodontal exams, and soft tissue measurements before any treatment begins.

1 visit (in-person) for baseline scans, x-rays, photographs, and periodontal measurements

Orthodontic Appliance Placement and Surgical Procedure

Duration - 1 week between appliance placement and surgery

Participants receive orthodontic appliance placement followed one week later by flapless piezocision surgical intervention with either soft tissue grafting or bone grafting as randomized.

1 visit for appliance placement and 1 visit for surgery (both in-person)

Active Orthodontic Treatment

Duration - Approximately 6 months

Participants undergo orthodontic treatment with periodic archwire adjustments every two weeks, starting immediately after surgery and continuing for approximately 6 months.

Biweekly visits for archwire changes and orthodontic adjustments for up to 6 months

Monthly Follow-up Assessments

Duration - 6 months concurrent with active treatment

Participants have monthly intraoral scans and periodontal evaluations to monitor treatment progress and periodontal health.

Monthly visits for intraoral scanning and periodontal assessments during treatment

Final Assessment and Appliance Removal

Duration - 1 day

At the end of the treatment period, participants undergo final clinical evaluations including intraoral scans, periodontal charting, and assessment of soft tissue and bone changes before removal of orthodontic appliances.

1 visit (in-person) for final assessments and appliance removal

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

C

Conchita Martin, Prof

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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