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Malocclusion, Angle Class II, Division 1NCT07442825

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

A study testing Flapless Corticotomy (Piezocision), Level Laser Therapy (LLLT) and Traditional treatment in people with Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 28 years
Conditions the study is for
Malocclusion, Angle Class II, Division 1
What is being tested?
Flapless Corticotomy (Piezocision), Level Laser Therapy (LLLT) and Traditional treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSyria
Study dates
6 May 2023to 18 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 28 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Syria1 site
  • Orthodontics Department, Faculty of Dentistry

    Damascus, Syrian Arab Republic, DM20AM19

Other trials in Syria

About this study

Official title: 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.

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.

Read the detailed description

Class II, Division 1 malocclusion is a common condition often treated by extracting upper premolars and retraction of the front teeth (en-masse retraction). This phase can take 9-12 months, increasing the risk of complications like poor oral hygiene, gum inflammation, and external apical root resorption (EARR). To address this, methods to accelerate tooth movement have been developed, including surgical (piezocision) and non-surgical (LLLT) techniques. While these methods aim to reduce treatment time, their combined effects on safety outcomes, such as EARR and periodontal health, are unclear. This three-arm randomized controlled trial evaluates the effects of en-masse retraction assisted by piezocision combined with LLLT (FC+LLLT), compared to piezocision alone (FC) and conventional treatment (CONT). Sixty-six patients were randomly assigned to the three groups. The piezocision procedure involved 18 minimal incisions and cortical bone perforations using a piezosurgery tip. The FC+LLLT group received adjunctive Ga-Al-As diode laser (808 nm, 1.1 W, 4 J/point) at multiple sessions. En-masse retraction was performed with 250g force using Ni-Ti coil springs from mini-screws. EARR was measured on standardized panoramic radiographs at T0 (pre-treatment), T1 (pre-retraction), and T2 (post-retraction) using a crown-length correction method. Periodontal health (Gingival Index, Papillary Bleeding Index, Dental Plaque Index, and Gingival Recession) was assessed at the same time points. The study aims to determine if these acceleration techniques increase the risk of these iatrogenic complications.

Being tested
Flapless Corticotomy (Piezocision), Level Laser Therapy (LLLT), Traditional treatment
Medical subject headings
Malocclusion, Angle Class II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flapless Corticotomy (Piezocision)Procedure or surgery

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

  • Level Laser Therapy (LLLT)Procedure or surgery

    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.

  • Traditional treatmentProcedure or surgery

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

Study groups in NCT07442825
Study groupRoleWhat they receive
The FC+LLLT GroupExperimentalParticipants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) and subsequent low-level laser therapy (LLLT).
Receives: Procedure: Level Laser Therapy (LLLT)
The FC GroupExperimentalParticipants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) alone
Receives: Procedure: Flapless Corticotomy (Piezocision)
The control groupActive comparatorParticipants in this arm receive conventional en-masse retraction with no surgical or laser adjuncts
Receives: Procedure: Traditional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: (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).

  2. Change in the Gingival Index

    Assessment will be performed using a gingival probe according to the Silness and Loe method:

    1. Normal gingiva.
    2. Mild inflammation: slight color change, slight edema. No bleeding on probing.
    3. Moderate inflammation: redness, edema, and glazing. Bleeding on probing.
    4. Severe inflammation: marked redness and edema, ulceration, and tendency to spontaneous bleeding.

    Measured: (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).

  3. Change in the Dental Plaque Index

    Assessment will be performed using a gingival probe according to the Silness and Loe method.

    1. No plaque.
    2. 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.
    3. Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye.
    4. Abundance of soft matter within the gingival pocket and/or the tooth and the gingival margin.

    Measured: (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).

  4. 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.

    Measured: (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).

  5. 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

    Measured: (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)
  1. Change in Pulp Vitality

    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.

    Measured: (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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start6 May 2023
  3. Primary completion22 Dec 2024
  4. Study completion18 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07442825
Sponsor's protocol ID
UDDS-2026-Ortho-02
Status last verified
Feb 2026
First submitted
24 Feb 2026
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27696311
  • 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.

    PubMed 23787192
  • 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.

    PubMed 38131681
  • 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.

    PubMed 40353446
  • 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.

    PubMed 33158633
  • 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.

    PubMed 34688577

Questions about this trial

What is this clinical trial studying?

A study testing Flapless Corticotomy (Piezocision), Level Laser Therapy (LLLT) and Traditional treatment in people with Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07442825, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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