Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement

Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial

The primary aim of the study is to evaluate the effect of single and repeated piezocisions on the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both protocols on molar anchorage loss, as well as on canine root resorption.

Study Overview

• Status: Completed
• Conditions: Canine Retraction; Orthodontic Tooth Movement
• Intervention / Treatment: Procedure: Single Piezocision; Procedure: Repeated Piezocision

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of dentistry, Alexandria university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Malocclusion that requires at least the extraction of maxillary first premolars, such as Class I bimaxillary protrusion, and Class II division 1 cases.
• Normal shape and structure of the maxillary canines, with no history of root canal treatment

Exclusion Criteria:

• Patients who underwent previous orthodontic treatment.
• Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Piezocision	Procedure: Single Piezocision; Piezocision will be performed only once before the onset of canine retraction (T0) on one side of the maxillary arch that will be randomly chosen.
Experimental: Repeated Piezocision	Procedure: Repeated Piezocision; Piezocision will be repeated three times, on a monthly basis (T0, T1, and T2), over the 12-week study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of canine retraction	Several landmarks will be identified on the dental arch, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.	12 weeks
Measurement of molar anchorage loss	Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.	12 weeks
Measurement of canine root resorption	Root resorption of the maxillary canines will be evaluated and measured by comparing pre-retraction and post-retraction CBCT scans.	12 weeks
Bone Microstructure (Fractal Dimension)	Using the collected CBCT scans, the region of interest will be selected within the maxillary alveolar process, and the fractal dimension analysis will be performed using a special software for the maxillary canines in the experimental and control groups.	12 weeks
Alveolar bone density	From the acquired pre- and post-retraction CBCTs, bone density will be measured form a coronal cross-section of the maxillary arch around each canine in the experimental and control groups.	12 weeks
Alveolar bone thickness	The buccal bone thickness will also be measured at three points from the buccal bone to the root, at the coronal, mid-root, and apical level for each maxillary canine	12 weeks
Alveolar bone volume	From the pre- and post-retraction CBCTs (at T0 and T1), bone volume in areas of the maxillary alveolar process surrounding the canines will be measured using a special software.	12 weeks
Maxillary canine tipping	Tipping of the maxillary canine during retraction was evaluated by drawing vertical lines on the palatal surfaces of the lateral incisor and the canine that extend from the middle of the incisal edge of the lateral incisor and the cusp tip of the maxillary canine to the middle of the cervical line of each, thereby dividing each of them into equal halves. The distance between the lateral incisor and the canine was assessed at two points on their clinical crowns: incisal, and cervical, enabling the detection of crown tipping of the canine during retraction if there was a difference in the measurements between the both the assessed levels.	12 weeks

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Collaborators: Alexandria University
• Investigators: Principal Investigator: Farah Y Eid, PhD, Alexandria University; Study Director: Ahmed R El-Kalza, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: March 12, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No