Dental Malocclusion Clinical Trial
— Piezo_OrthoOfficial title:
Effect on the Periodontal Phenotype of Flapless Alveolar Decortication and Augmentation During Orthodontic Treatment: A Randomized Clinical Trial
NCT number | NCT06315348 |
Other study ID # | URI_116301123 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2024 |
Est. completion date | April 2025 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Odontology, University Complutense Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid | Osteology Foundation |
Spain,
REFERENCE LIST Charavet, C., Lecloux, G., Bruwier, A., Rompen, E., Maes, N., Limme, M., & Lambert, F. (2016). Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res, 95(9), 1003-1009.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 months | |
Primary | Plaque index (PlI) | Changes in PlI dichotomously assessed and expressed as the percentage of positive sites out of the total sites assessed. | 6 months | |
Primary | Bleeding on probbing (BoP) | Changes in BoP dichotomously assessed and expressed as the percentage of positive sites out of the total sites assessed | 6 months | |
Primary | Probing depth (PD) | Changes in PD and gingival recession/overgrowth, allowing for the calculation of clinical attachment level (CAL) | 6 months | |
Primary | External apical root resorption (EARR) | Presence of EARR measured in 3D Cone bean computed tomography (CBCT) | 6 months | |
Primary | Orthodontic tooth movement | Space analyses will be performed on study models with digital calipers. Similarly, the intercanine and intermolar distances will be measured at baseline and after the treatment to determine the level of expansion | 6 months | |
Secondary | Percentage of residual pockets (PD>4 mm). | Percentage of residual pockets (PD>4 mm). | 6 months | |
Secondary | Soft tissue thickness by PIROP ultrasound scanner | Changes in soft tissue thickness by PIROP ultrasound scanner | 6 months | |
Secondary | Gingival microvasculature | Changes in microvasculature by Laser Speckle Contrast Imaging before and after the surgical intervention | 6 months | |
Secondary | PROMs | PROMs including impact on quality of life (GOHAI), pain level after treatment and daily analgesic consumption following piezoincisions | 72 h and 15 days | |
Secondary | Adverse events (AEs) | Presence of adverse events (AEs) | During the study duration (6 months) |
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