Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement

NCT05782088 | Completed

• 1 other identifier: 200
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic Tooth Movement; Canine Retraction

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Single Piezocision

EXPERIMENTAL

Procedure: Single Piezocision

Repeated Piezocision

EXPERIMENTAL

Procedure: Repeated Piezocision

Interventions

Single Piezocision PROCEDURE

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.

Single Piezocision

Repeated Piezocision PROCEDURE

Piezocision will be repeated three times, on a monthly basis (T0, T1, and T2), over the 12-week study period.

Repeated Piezocision

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (1)

• Eid FY, El-Kalza AR. The effect of single versus multiple piezocisions on the rate of canine retraction: a randomized controlled trial. BMC Oral Health. 2024 Aug 30;24(1):1024. doi: 10.1186/s12903-024-04716-6.

  PMID: 39215274 DERIVED

Study Officials

• Farah Y Eid, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Ahmed R El-Kalza, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 23, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 15, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

EG (1)