NCT03406130

Brief Summary

The aim of the present randomized controlled clinical trial will compare Insignia orthodontic treatment to piezocision-assisted Insignia orthodontics in adult patients. The primary objective will be to determine the efficacy of piezocision-accelerated orthodontic treatment by measuring the treatment duration in both groups. The secondary objectives will be to compare periodontal health, alveolar crest changes, bone and gingival healing, analgesic intake and patient-centered outcomes between the 2 groups.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

January 12, 2018

Last Update Submit

January 19, 2018

Conditions

Tooth Overcrowding

Outcome Measures

Primary Outcomes (1)

  • Overall treatment time measurement (in days)

    The cumulative times from bracket placement to each archwire change and to orthodontic appliance removal will be recorded in days.

    1 year

Secondary Outcomes (4)

  • Comparison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.

    baseline, 1 year

  • Alveolar crest parameters measurements (CBCT in millimeters)

    baseline, 1 year

  • Comparison of radiographic parameters between the test group and the control group before (at baseline) and after orthodontic treatment (CBCT)

    baseline, 1 year

  • Comparison of Patient-centered outcomes (VAS questionnaire) between the test group and the control group before (at baseline) and after orthodontic treatment

    baseline, 1 year

Study Arms (2)

Insignia orthodontic treatment

ACTIVE COMPARATOR
Procedure: Orthodontic Procedure

Piezocision-assisted Insignia orthodontic treatment

EXPERIMENTAL
Procedure: Orthodontic ProcedureProcedure: Piezocision surgery

Interventions

Orthodontic ProcedurePROCEDURE

Damon self-ligating systems (Ormco) were used for all patients. The patients were allowed to choose between clear and metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in. copper nickel-titanium Damon arch forms were placed. The subjects returned every 2 wk, and the archwires were changed only when full bracket engagement were achieved. The sequence of archwires was the following: 0.018-in., 0.014 × 0.025-in., and 0.018 × 0.025-in. copper nickel-titanium archwires were used for alignment, while 0.019 × 0.025-in. stainless-steel archwires were used for fine-tuning. Following the alignment steps, impressions were taken, and a blinded senior orthodontist validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and fixed and removable retainers were placed.

Insignia orthodontic treatmentPiezocision-assisted Insignia orthodontic treatment
Piezocision surgeryPROCEDURE

The piezocision surgery was performed 1 week after orthodontic appliance placement. The surgical protocol was performed as described by Dibart and al. (Dibart et al. 2009). However, to avoid bias, hard and soft tissue augmentations were not considered. The patients received local anesthesia in both arches; vertical interproximal microincisions were created below each interdental papilla. In cases of root proximity (i.e., \<2 mm of interdental bone), this procedure was not performed. These incisions were kept to a minimum (varying from 5 to 8 mm). Next, with a vertical piezoelectric device, 5-mm-long and 3-mm-deep corticotomies were made, and no subsequent sutures were required. The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intake for 1 wk. Anti-inflammatories were prohibited to avoid interference with the RAP.

Piezocision-assisted Insignia orthodontic treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring maxillary and mandible orthodontic treatment (both arches)
  • Adult patients with completed growth based on the cervical vertebral maturation method as described by Baccetti et al. (Baccetti et al. 2002)
  • Minimal to moderate maxillary and mandibular anterior crowding at baseline (irregularity index \<6;(Little 1975));
  • American Society of Anesthesiology I or II (I = nor- mal healthy patient; II = patient with mild systemic disease);
  • Adequate dento-oral health (i.e., the absence of periodontal diseases, periapical infection, or untreated caries).

You may not qualify if:

  • controlled periodontitis with a loss of alveolar support \>10%
  • gingival recession \>2 mm
  • smokers
  • altered bone metabolism (e.g., due to antiresorptive drug, steroid, or immunosuppressant use)
  • mental or motor disabilities; and 6) pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Charavet C, Lecloux G, Jackers N, Maes N, Lambert F. Patient-reported outcomes measures (PROMs) following a piezocision-assisted versus conventional orthodontic treatments: a randomized controlled trial in adults. Clin Oral Investig. 2019 Dec;23(12):4355-4363. doi: 10.1007/s00784-019-02887-z. Epub 2019 Apr 6.

    PMID: 30955096DERIVED

  • Charavet C, Lecloux G, Jackers N, Albert A, Lambert F. Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults. Eur J Orthod. 2019 Sep 21;41(5):495-501. doi: 10.1093/ejo/cjy082.

    PMID: 30649257DERIVED

MeSH Terms

Interventions

Orthodontics

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. France Lambert

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 23, 2018

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01