Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment

NCT06315348 | Recruiting

• 1 other identifier: URI_116301123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Dental Malocclusion; Maxillary Deficiency

Keywords

Periodontal phenotype; Flapless piezoincision; Orthodontic tooth movement; Tissue augmentation

Outcome Measures

Primary Outcomes (6)

• 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

• Plaque index (PlI)

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

  6 months

• 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

• Probing depth (PD)

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

  6 months

• External apical root resorption (EARR)

  Presence of EARR measured in 3D Cone bean computed tomography (CBCT)

  6 months

• 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 Outcomes (5)

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

  6 months

• Soft tissue thickness by PIROP ultrasound scanner

  6 months

• Gingival microvasculature

  6 months

• PROMs

  72 h and 15 days

• Adverse events (AEs)

  During the study duration (6 months)

Study Arms (2)

Collagen matrix

EXPERIMENTAL

a cross-linked volume stable collagen matrix (VCMX; Geistlich Fibro-Gide, Geistlich Pharma AG)

Procedure: flapless alveolar decortication with augmentation

Xenograft

ACTIVE COMPARATOR

a graft consisting of bovine hydroxyapatite xenograft (Geistlich Bio-Oss; Geistlich Pharma AG), covered by a native collagen membrane (Geistlich Bio-Gide; Geistlich Pharma AG), tagged with pins at the ends.

Procedure: flapless alveolar decortication with augmentation

Interventions

flapless alveolar decortication with augmentation PROCEDURE

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.

Also known as: flapless piezoincision with augmentation

Collagen matrix; Xenograft

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain) looking for orthodontic therapy.
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Osteology Foundation: collaborator

Study Sites (1)

Faculty of Odontology, University Complutense Madrid

Madrid, 28040, Spain

RECRUITING

Related Publications (1)

• 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. doi:10.1177/0022034516645066 Charavet, C., Lecloux, G., Jackers, N., Albert, A., & Lambert, F. (2019). Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults. Eur J Orthod, 41(5), 495-501. doi:10.1093/ejo/cjy082 Charavet, C., Lecloux, G., Jackers, N., Maes, N., & Lambert, F. (2019). Patient-reported outcomes measures (PROMs) following a piezocision-assisted versus conventional orthodontic treatments: a randomized controlled trial in adults. Clin Oral Investig, 23(12), 4355-4363. doi:10.1007/s00784-019-02887-z

  RESULT

MeSH Terms

Conditions

Malocclusion; Retrognathia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Eduardo Montero, Prof

CONTACT

+34 91 3941901; eduardomonterosolis@ucm.es

Conchita Martin, Prof

CONTACT

+34 91 3941923; mariacom@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded parties will not be aware of the type augmentation used during the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparative 2-arm parallel double-blinded randomized controlled clinical trial

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

ES (1)