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Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

ConditionsDental MalocclusionMaxillary Deficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-70
SponsorUniversidad Complutense de Madrid

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • flapless alveolar decortication with augmentation

    Procedure/Surgery

    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. Piezocisions will be performed using a piezoelectric device.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Collagen matrixExperimental treatment 1 intervention
Group B: XenograftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Soft tissue contour changes pre- and post- orthodontic therapy

Linear and volumetric changes of soft tissue (gingiva) using superimposition of STL files of dental casts at baseline and post-ortho

Time frame
6 months
2

Plaque index (PlI)

Changes in PlI dichotomously assessed and expressed as the percentage of positive sites out of the total sites assessed.

Time frame
6 months
3

Bleeding on probbing (BoP)

Changes in BoP dichotomously assessed and expressed as the percentage of positive sites out of the total sites assessed

Time frame
6 months
4

Probing depth (PD)

Changes in PD and gingival recession/overgrowth, allowing for the calculation of clinical attachment level (CAL)

Time frame
6 months

Secondary outcomes

1

Percentage of residual pockets (PD>4 mm).

Percentage of residual pockets (PD\>4 mm).

Time frame
6 months
2

Soft tissue thickness by PIROP ultrasound scanner

Changes in soft tissue thickness by PIROP ultrasound scanner

Time frame
6 months
3

Gingival microvasculature

Changes in microvasculature by Laser Speckle Contrast Imaging before and after the surgical intervention

Time frame
6 months
4

PROMs

PROMs including impact on quality of life (GOHAI), pain level after treatment and daily analgesic consumption following piezoincisions

Time frame
72 h and 15 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Complutense de Madrid

Lead sponsor

Osteology Foundation

Collaborator

Source ClinicalTrials.gov
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