Effectiveness of Piezocision Versus Low-level Laser Therapy During Orthodontic Canine Retraction: A Comparative Controlled Clinical Study
Phase: NA
Conditions: Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion, Class I Malocclusion
Sponsor: Hesham Nabil Ali Al-Qamhawy

Official title: Effectiveness of piezocision versus
low-level laser therapy during orthodontic canine
retraction: A comparative controlled clinical study
NCT Number: “Not yet assigned”
Document date: March 2, 2026

Effectiveness of piezocision versus low-level laser therapy during
orthodontic canine retraction: A comparative controlled clinical study
Protocol submitted in partial fulfillment of the requirements for Master Degree of
Dental Science in Orthodontics
by
Hesham Nabil Ali Alsayed
BDS, 2019G, Faculty of Dental Medicine, Boys, Cairo, Al-Azhar University
Freelance Dentist
Supervisors
Prof. Dr. Farouk Ahmed Hussein
Professor, Department of Orthodontics,
Faculty of Dental Medicine, Boys, Cairo, Al-Azhar University
Dr. Elhassanein Hussein Elhassanein
Associate Professor, Department of Orthodontics,
Faculty of Dental Medicine, Boys, Cairo, Al-Azhar University
Dr. Ahmed Mohamed Bilal
Lecturer,
Department of Oral Medicine, Periodontology, Diagnosis, & Oral Radiology,
Faculty of Dental Medicine, Boys, Cairo, Al-Azhar University
Department of Orthodontics
Faculty of Dental Medicine, Boys, Cairo
Al-Azhar University
2026G - 1447H

Introduction
While orthodontic treatment offers substantial benefits, its prolonged dura-
tion carries significant risks. Orthodontic appliances, particularly fixed ones, com-
plicate oral hygiene, predisposing patients to dental caries.1 In addition to hygiene
concerns, orthodontic forces can increase the likelihood of iatrogenic effects such
as periodontal disease and root resorption.2–4
Consequently, a primary goal in contemporary orthodontics is to reduce over-
all treatment time and mitigate these potential complications. To achieve this, nu-
merous techniques have been developed to accelerate orthodontic tooth movement
(OTM). These approaches are broadly classified into two categories: surgical and
non-surgical interventions. Surgical methods range from invasive procedures like
corticotomy to minimally invasive ones such as micro-osteoperforations.5 Non-
surgical approaches, on the other hand, utilize physical stimuli like low-level laser
therapy (LLLT)6 or locally delivered pharmacological agents to modulate the bio-
logical response.7–11
Among the minimally invasive surgical techniques, piezocision, first intro-
duced by Dibart et al.,12 became widely adopted. It accelerates OTM by employ-
ing a piezoelectric knife to create precise micro-incisions and localized alveolar
decortications.13–15 This procedure induces the regional acceleratory phenomenon
(RAP), a temporary burst of localized bone remodeling that decreases bone den-
sity and resistance, facilitating more rapid OTM.16 Numerous clinical studies
have demonstrated the efficacy of piezocision in significantly reducing treatment
time.17–28
In contrast, LLLT, also known as photobiomodulation, has emerged as a
1

prominent non-surgical alternative. This technique applies low-intensity light to
target tissues, aiming to stimulate cellular metabolism, increase vascularity, and
modulate inflammatory mediators.29–31 Its non-invasive nature makes it an attrac-
tive option for both patients and clinicians.32,33
Piezocision and LLLT represent distinct philosophies for accelerating OTM:
one relying on surgically induced RAP and the other on non-invasive photo-
biomodulation. While previous studies have attempted to compare these interven-
tions, their findings remain contradictory. Türker et al.22 reported that LLLT was
more effective only during the initial month, with no significant difference overall
compared to piezocision. In contrast, Moradinejad et al.20 found that a combina-
tion of both methods was superior, but piezocision alone was more effective than
LLLT.
Notably, these studies utilized a split-mouth design,20,22 which may intro-
duce a carry-over effect where systemic factors or cross-arch biostimulation influ-
ence the contralateral side, potentially masking true differences.34–36 Therefore, a
parallel-group randomized controlled trial with a separate control group is neces-
sary to eliminate these confounding variables and provide a clearer evaluation of
their efficacy.37
This study, therefore, will be directed to compare the clinical efficacy of
piezocision and LLLT against a control group during orthodontic canine retrac-
tion. The null hypothesis posits that there is no statistically significant difference
in the rate of OTM among the three groups.
2

Aim of the study
The present comparative controlled clinical study will be directed to compare
the effectiveness of piezocision and LLLT during orthodontic canine retraction.
3

Materials and methods
1 Study design
A prospective, single-center, three-arm, parallel-group, randomized con-
trolled clinical trial.
2 PICO(T) Question
Population (P):
Orthodontic patients requiring bilateral maxillary first
premolar extraction and subsequent canine retraction.
Intervention 1 (I1):
Piezocision-assisted canine retraction.
Intervention 2 (I2):
LLLT-assisted canine retraction.
Comparison (C):
Conventional canine retraction without any acceleration
method (Control group).
Outcome (O):
Rate of canine retraction.
Time (T):
A four-month period from the beginning of the active ca-
nine retraction phase.25,38
PICO(T) Question:
In orthodontic patients requiring bilateral maxillary first
premolar extraction followed by canine retraction, is there a difference in the rate
of canine retraction among patients treated with piezocision-assisted retraction,
LLLT-assisted retraction, and conventional retraction over a four-month period?
3 Study setting and population
This study will be carried out on patients eligible for orthodontic treatment
from the Outpatient Clinics of the Department of Orthodontics, Faculty of Dental
Medicine, Boys, Cairo, Al-Azhar University.
4

Figure 1: G*Power output for sample size estimation.
4 Sample Size Calculation
An a priori power analysis was conducted using G*Power software (version
3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany) to deter-
mine the appropriate sample size for a one-way analysis of variance (ANOVA).
The calculation was based on parameters derived from a comparable random-
ized controlled trial,38 which reported a clinically significant difference of > 1.6
mm in canine retraction over a 4-month period between intervention and control
groups. Based on this substantial effect size (ǚ ≈0.88), an alpha level of 0.05, and
a power of 85%, a minimum total sample size of 18 participants (6 per group) was
determined to be sufficient to detect significant differences (Figure 1).
To account for potential attrition or withdrawal during the follow-up period,
the sample size was increased by approximately 15%. Therefore, a total of 21
participants will be recruited and randomly allocated into three equal groups (Ǡ =
7).
5

5 Eligibility criteria of population20
5.1 Inclusion criteria
1. Age range 18-25 years.
2. Patients with crowding or protrusion requiring at least bilateral maxillary
first premolar extraction followed by symmetrical canine retraction.
3. Full set of permanent dentition (third molar not considered).
4. Patients with good oral hygiene.
5.2 Exclusion criteria
1. Previous orthodontic treatment.
2. Patients taking medications or suffering from systemic conditions that can
affect orthodontic tooth movement.
3. Active periodontal diseases and/or untreated carious lesions.
4. Congenital orofacial deformities.
5.3 Criteria of discontinuation
1. Multiple missing appointments.
2. Poor oral hygiene.
3. Multiple broken appliances to the extent that interferes with obtaining the
treatment objectives.
6 Ethical considerations
The research protocol is approved by the ethical committee of the Faculty of
Dental Medicine, Al-Azhar University. The aim of the study will be discussed with
6

each patient, and he/she will sign an informed written consent before commencing
the study. Moreover, patients will be given written instructions to follow during
the treatment.
7 Orthodontic records
For each patient, the following records will be taken before the onset of the
treatment:
1. Standardized extra and intra oral photographs.
2. Orthodontic study model.
3. Panoramic radiograph.
4. Lateral cephalometric radiograph.
8 Interventions20,28,38,39
All participants will receive standard fixed orthodontic appliances. Canine
retraction will be initiated using a constant force from a NiTi closed coil spring
anchored to a maxillary mini-implant. Participants will be randomly assigned to
one of three parallel groups.
8.1 Group 1: Piezocision28
On both right and left sides, a minimally invasive flapless piezocision proce-
dure will be performed each month from the beginning of the canine retraction for
a total four-month period.
7

8.2 Group 2: LLLT22,39
On both right and left sides, LLLT will be performed at the beginning of
canine retraction, after 3, 7, 14 days, and then every 14 days for a total four-month
period.
8.3 Group 3: Control Group38
Participants in this group will receive the same fixed appliance and retraction
mechanics as the experimental groups. However, no surgical intervention or laser
application will be performed.
9 Outcome measures
9.1 Primary outcome20,38
The primary outcome will be the assessment of the amount and rate of max-
illary canine distal movement.
9.2 Secondary outcomes20,38
The secondary outcomes will be the evaluation of the maxillary canine’s ro-
tation and tipping, also evaluation of the maxillary first molar’s mesial movement
(anchorage loss) and rotation, and finally pain assessment.
8

10 Observations20,38
10.1 Clinical measurements20,38
The amount of maxillary canine distal movement and extraction space closure
in millimeters will be measured.
10.2 Study model measurements20,38
These will be evaluated via three-dimensional (3D) digital study models ob-
tained before the start of canine retraction (T0) and after four months of canine
retraction (T4). The degree of maxillary canine retraction, rotation, tipping, and
the maxillary first molar’s mesial movement (anchorage loss), and rotation will be
evaluated.
10.3 Pain assessment20,38
Pain intensity will be evaluated by a 10 cm visual analogue scale (VAS).
11 Data management and analysis
The data will be collected, tabulated, computed, and statistically analyzed
using a suitable statistical program.
9

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