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Completed

NCT Number: NCT05782088

Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement

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.

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Key information

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Repeated Piezocision

Procedure

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

Primary outcomes

  1. Measurement of canine retraction

    Time frame: 12 weeks

    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.

  2. Measurement of molar anchorage loss

    Time frame: 12 weeks

    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.

  3. Measurement of canine root resorption

    Time frame: 12 weeks

    Root resorption of the maxillary canines will be evaluated and measured by comparing pre-retraction and post-retraction CBCT scans.

  4. Bone Microstructure (Fractal Dimension)

    Time frame: 12 weeks

    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.

  5. Alveolar bone density

    Time frame: 12 weeks

    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.

  6. Alveolar bone thickness

    Time frame: 12 weeks

    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

  7. Alveolar bone volume

    Time frame: 12 weeks

    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.

  8. Maxillary canine tipping

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2023
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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