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A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

C

CES University

Status and phase

Unknown
Phase 4

Conditions

Class I Malocclusion
Thin Gingival Biotype
Other Periodontal Diseases

Treatments

Drug: Mucograft
Procedure: Decortication
Device: Orthodontics

Study type

Interventional

Funder types

Other

Identifiers

NCT02866929
ODCES001

Details and patient eligibility

About

Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged in the past few years as an appealing alternative for patients and practitioners. In the context of a thin biotype, these approaches pose a burden that could precipitate periodontal detrimental changes. Therefore, case selection and the implementation of periodontal biotype enhancing strategies become a relevant consideration to ensure long-term successful treatment outcomes. This study focuses on the biological and clinical value of the use of a porcine naturally cross-linked collagen matrix known as Mucograft®. Within the scope of Surgically Accelerated Orthodontic Treatment (SAOT) the structural and material features of Mucograft® provide: 1) A protective effect to the thin biotype upon rapid orthodontic protusive/proinclination movements and 2) Mucograft® enhances the therapeutic window effect that supports an increase on tooth movement rate. The designs of this randomized controlled clinical trial includes a cohort of 40 subjects distributed on the following groups I) Ortho tx, II) Ortho tx + Decortication, III) Ortho tx + Decortication + Mucograft®, and IV) Ortho tx + Mucograft®. Comparing clinical, tomographic and digital impression derived measurements will capture the clinical phenotype; while the biologic phenotype will be derived from evaluating crevicular fluid levels of tooth movement mediators such as Interleukin 1-β and Interleukin-1RA. The significance and innovative value of this proposal stems from the use of Mucograft® as an ideal collagen-based biotype enhancer when performed along with the corticotomy. This approach could prove to be effective to further increase the therapeutic window that allows accelerating orthodontic treatment and, at the same time, could decrease the recession risk in movements of proclination of antero-inferior incisors. Besides, the use of a collagen scaffold alone could potentially trigger a comparable orthodontic acceleratory outcome that could be evaluated as an alternative to decortication.

Enrollment

40 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Angle's class I malocclusion
  • Little's grade II or III dental crowding
  • Periodontally stable patients
  • Patients with no more than 2 mm of keratinized gingiva in at least two sites of the antero-inferior region

Exclusion criteria

Patient with presence of marginal tissue recessions on inferior incisors

  • Patients with a metabolic or neoplastic alteration
  • History of orthopedic surgery in the last 6 months
  • History of fractures in the last 6 months
  • History of bisphosphonates use
  • Patient with systemic compromise

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

40 participants in 4 patient groups

Conventional orthodontic treatment
Active Comparator group
Description:
Patients that will receive conventional orthodontics
Treatment:
Device: Orthodontics
Orthodontics with decortication
Experimental group
Description:
Patients that will receive orthodontic treatment with selective alveolar decortication
Treatment:
Device: Orthodontics
Procedure: Decortication
Orthodontics decortication and Mucograft
Experimental group
Description:
Orthodontic treatment, selective alveolar decortication and Mucograft® on the mandibular anterior segment
Treatment:
Device: Orthodontics
Drug: Mucograft
Procedure: Decortication
Orthodontics and Mucograft®
Experimental group
Description:
Patients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment
Treatment:
Device: Orthodontics
Drug: Mucograft

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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