Evaluating Laser and Piezocision vs. Piezocision Alone on Root Resorption and Gingival Health During Tooth Retraction

NCT07442825 | Completed DMC

• 1 other identifier: UDDS-2026-Ortho-02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to determine whether using a special laser (low-level laser therapy, or LLLT) in combination with a minor surgical procedure (piezocision) can safely accelerate orthodontic treatment. We are looking at its effect on two main safety issues: root shortening (root resorption) and gum health. We will compare three groups of patients who have their front teeth pulled back: one group receives the surgery and the laser, one receives the surgery alone, and one receives standard braces. We will measure root length on X-rays and check gums at the start, before the retraction phase, and after all the space is closed.

Conditions

Malocclusion, Angle Class II, Division 1

Outcome Measures

Primary Outcomes (5)

• Change in external apical root resorption

  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).

  (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).

• Change in the Gingival Index

  Assessment will be performed using a gingival probe according to the Silness and Loe method: 0\. Normal gingiva. 1. Mild inflammation: slight color change, slight edema. No bleeding on probing. 2. Moderate inflammation: redness, edema, and glazing. Bleeding on probing. 3. Severe inflammation: marked redness and edema, ulceration, and tendency to spontaneous bleeding.

  (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).

• Change in the Dental Plaque Index

  Assessment will be performed using a gingival probe according to the Silness and Loe method. 0\. No plaque. 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after a disclosing solution is applied or after the probe is used on the tooth surface. 2. Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or the tooth and the gingival margin.

  (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).

• Change in the Bleeding Index

  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. 1. A single discrete bleeding point appears. 2. Several isolated bleeding points or a single fine line of blood appear. 3. The interdental triangle fills with blood shortly after probing. 4. Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.

  (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).

• Change in Gingival Width

  This will be measured in millimeters from the cement-enamel junction to the gingival margin level around the six anterior teeth

  (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).

Secondary Outcomes (1)

• Change in Pulp Vitality

  (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).

Study Arms (3)

The FC+LLLT Group

EXPERIMENTAL

Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) and subsequent low-level laser therapy (LLLT).

Procedure: Level Laser Therapy (LLLT)

The FC Group

EXPERIMENTAL

Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) alone

Procedure: Flapless Corticotomy (Piezocision)

The control group

ACTIVE COMPARATOR

Participants in this arm receive conventional en-masse retraction with no surgical or laser adjuncts

Procedure: Traditional treatment

Interventions

Flapless Corticotomy (Piezocision) PROCEDURE

Performed 4 days before retraction. Eighteen minimal intrasulcular incisions and cortical bone perforations (3mm depth) using a piezosurgery microsaw tip.

The FC Group

Level Laser Therapy (LLLT) PROCEDURE

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.

The FC+LLLT Group

Traditional treatment PROCEDURE

Patients in this group will be traditionally treated without being subjected to corticotomy or LLLT.

The control group

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Orthodontics Department, Faculty of Dentistry

Damascus, Syrian Arab Republic, DM20AM19, Syria

Location

Related Publications (6)

• 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.

  PMID: 27696311 BACKGROUND

• 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.

  PMID: 23787192 BACKGROUND

• 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.

  PMID: 38131681 BACKGROUND

• 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.

  PMID: 40353446 BACKGROUND

• 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.

  PMID: 33158633 BACKGROUND

• 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.

  PMID: 34688577 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mudar Mohammad Mousa, DDS, MSc

  Department of Orthodontics, Faculty of Dentistry, University of Damascus

  PRINCIPAL INVESTIGATOR

• Mohammad Younis Hajeer, DDS, MSc, PhD

  Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus

  STUDY CHAIR

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

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: May 6, 2023
• Primary Completion: December 22, 2024
• Study Completion: March 18, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)