Effect of Piezoelectric Alveolar Decortication on Post-Orthodontic Lower Incisors Stability: A Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Retention
• Intervention / Treatment: Procedure: Piezoelectric Alveolar Decortication, fibrotomy

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: piezocision group; piezocision surgical procedure was done according to Dibart's et al,	Procedure: Piezoelectric Alveolar Decortication, fibrotomy
Experimental: fiberotomy group; the fiberotomy procedure followed Edward's et al	Procedure: Piezoelectric Alveolar Decortication, fibrotomy
No Intervention: control group; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2016
• Primary Completion (Actual): September 5, 2019
• Study Completion (Actual): September 5, 2019

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Retention; Relapse; Fibrotomy; Piezocision
• Other Study ID Numbers: 16011965

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes