NCT05014308

Brief Summary

To assess the effect of piezocision on post-orthodontic lower anterior teeth stability as compared to fiberotomy and conventional Hawley retainers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

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

March 15, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2019

Completed
2 years until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

3.5 years

First QC Date

April 11, 2017

Last Update Submit

August 19, 2021

Conditions

Retention

Keywords

Retention; Relapse; Fibrotomy; Piezocision;

Outcome Measures

Primary Outcomes (2)

  • lower incisors stability after 6 months

    study models will be evaluated 6 months after debonding Incisor Irregularity Index of lower anterior teeth will be measured using a digital caliper

    6 months

  • lower incisors stability after 12 months

    study models will be evaluated 12 months after debonding Incisor Irregularity Index of lower anterior teeth will be measured using a digital caliper

    12 months

Study Arms (3)

piezocision group

EXPERIMENTAL

piezocision surgical procedure was done according to Dibart's et al,

Procedure: Piezoelectric Alveolar Decortication, fibrotomy

fiberotomy group

EXPERIMENTAL

the fiberotomy procedure followed Edward's et al

Procedure: Piezoelectric Alveolar Decortication, fibrotomy

control group

NO INTERVENTION

no intervention

Interventions

Piezoelectric Alveolar Decortication, fibrotomyPROCEDURE
fiberotomy grouppiezocision group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who had lower anterior irregularity (crowding, rotation, buccally or lingually displaced) will be selected.
  • Good oral hygiene, healthy gingiva and no evidence of bone loss as seen on the radiograph.
  • Healthy systemic conditions.
  • Patients pass the growth spurt according to cervical vertebral maturation method as described by Baccetti et al.
  • Availability of good quality records at pretreatment and post-treatment.

You may not qualify if:

  • Patients that has any signs of active periodontal disease or evidence of bone loss on the radiograph.
  • Patients with systemic disease such as osteoporosis and diabetes.
  • Smoking patients.
  • Study casts did not include all mandibular permanent incisors, canines, and first molars.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master resident

Study Record Dates

First Submitted

April 11, 2017

First Posted

August 20, 2021

Study Start

March 15, 2016

Primary Completion

September 5, 2019

Study Completion

September 5, 2019

Last Updated

August 20, 2021

Record last verified: 2021-08