- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442825
Evaluating Laser and Piezocision vs. Piezocision Alone on Root Resorption and Gingival Health During Tooth Retraction
Evaluation of the Effects of Low-Level Laser Therapy Combined With Piezocision vs. Piezocision Alone on External Apical Root Resorption and Periodontal Indices Following the En-Masse Retraction of Upper Anterior Teeth: A Three-Arm Randomized Controlled Trial.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Syrian Arab Republic
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Damascus, Syrian Arab Republic, Syria, DM20AM19
- Orthodontics Department, Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy patients aged 17-28 years.
- Diagnosed with a Class II division 1 malocclusion, indicated for extraction of the upper first premolars, with an overjet of 4-10 mm and a normal or increased facial height assessed clinically and cephalometrically using three angles (MM= 23ᵒ-33ᵒ, Jarabak Ratio ≤ 64%, and Y-axis angle= 66ᵒ-75ᵒ)
- A skeletal Class II relationship, confirmed by a cephalometric ANB angle between 4° and 7°
- An overbite of 0%-33%
- Good oral hygiene, defined by a probing depth of ≤3 mm and no radiographic evidence of alveolar bone loss
- Absence or a mild level of crowding
- A full complement of teeth, excluding third molars.
Exclusion Criteria:
- A history of previous orthodontic treatment
- Any systemic disease or medication known to interfere with orthodontic tooth movement.
- Congenitally missing or extracted teeth in the maxilla (except third molars)
- Poor oral hygiene,
- Active periodontal disease (probing depth ≥4 mm, radiographic bone loss, gingival index >1, plaque index >1)
- Moderate to severe maxillary crowding (Little's Irregularity Index ≥4).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The FC+LLLT Group
Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) and subsequent low-level laser therapy (LLLT).
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Ga-Al-As diode laser (808 nm, 1.1 W, 4 J/point, 15 sec/point) applied to 32 points per session.
Administered on days 0, 3, 7, 14, and then bi-weekly for a total of four sessions post-initiation, starting six weeks post-corticotomy.
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Experimental: The FC Group
Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) alone
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Performed 4 days before retraction.
Eighteen minimal intrasulcular incisions and cortical bone perforations (3mm depth) using a piezosurgery microsaw tip.
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Active Comparator: The control group
Participants in this arm receive conventional en-masse retraction with no surgical or laser adjuncts
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Patients in this group will be traditionally treated without being subjected to corticotomy or LLLT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in external apical root resorption
Time Frame: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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The root length will be measured for each root of six upper anterior teeth.
The method originally described by Linge and Linge will be used.
The amount of root resorption (in millimeters) will be calculated using the following equation: Root Resorption = Root Length (T0) - (Root Length (T1) × Correction Factor).
The Correction Factor will be calculated by dividing the crown Length (T0) to the crown Length (T1).
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(T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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Change in the Gingival Index
Time Frame: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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Assessment will be performed using a gingival probe according to the Silness and Loe method: 0. Normal gingiva.
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(T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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Change in the Dental Plaque Index
Time Frame: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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Assessment will be performed using a gingival probe according to the Silness and Loe method. 0. No plaque.
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(T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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Change in the Bleeding Index
Time Frame: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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The Bleeding index will be used to assess the status of periodontal tissues and the amount of congestion in the gingival margins around the anterior teeth. According to Muhlemann, an assessment will be performed using a gingival probe. 0. No bleeding.
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(T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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Change in Gingival Width
Time Frame: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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This will be measured in millimeters from the cement-enamel junction to the gingival margin level around the six anterior teeth
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(T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Pulp Vitality
Time Frame: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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This will be assessed using a cold test with -50° ethyl chloride spray.
The patient's pain response will be recorded to confirm pulp vitality.
There are two answers: (1) Yes, or (2) No.
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(T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mudar Mohammad Mousa, DDS, MSc, Department of Orthodontics, Faculty of Dentistry, University of Damascus
- Study Chair: Mohammad Younis Hajeer, DDS, MSc, PhD, Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus
Publications and helpful links
General Publications
- Al-Ibrahim HM, Hajeer MY, Alkhouri I, Zinah E. Leveling and alignment time and the periodontal status in patients with severe upper crowding treated by corticotomy-assisted self-ligating brackets in comparison with conventional or self-ligating brackets only: a 3-arm randomized controlled clinical trial. J World Fed Orthod. 2022 Feb;11(1):3-11. doi: 10.1016/j.ejwf.2021.09.002. Epub 2021 Oct 21.
- Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4.
- Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
- Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
- Mousa MM, Hajeer MY, Burhan AS, Darwich KMA, Almahdi WH, Aljabban O, Awawdeh MA, Almasri IA. Patient-Reported Outcome Measures of Flapless Corticotomy with Low-Level Laser Therapy in En Masse Retraction of Upper Anterior Teeth: A Three-Arm Randomized Controlled Trial. Clin Pract. 2023 Nov 22;13(6):1501-1519. doi: 10.3390/clinpract13060132.
- Mousa MM, Hajeer MY, Alam MK, Aljabban O, Almahdi WH. Evaluation of low-level laser therapy and piezocision in the en-masse retraction of upper anterior teeth. Eur J Orthod. 2025 Apr 8;47(3):cjaf026. doi: 10.1093/ejo/cjaf026.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-2026-Ortho-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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