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.
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
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.
- Conditions
- Malocclusion, Angle Class II, Division 1
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Level Laser Therapy (LLLT) |
| The FC Group | Experimental | Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) alone Receives: Procedure: Flapless Corticotomy (Piezocision) |
| The control group | Active comparator | Participants 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.
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).
Change in the Gingival Index
Assessment will be performed using a gingival probe according to the Silness and Loe method:
- Normal gingiva.
- Mild inflammation: slight color change, slight edema. No bleeding on probing.
- Moderate inflammation: redness, edema, and glazing. Bleeding on probing.
- 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).
Change in the Dental Plaque Index
Assessment will be performed using a gingival probe according to the Silness and Loe method.
- No plaque.
- 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.
- Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye.
- 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).
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.
- A single discrete bleeding point appears.
- Several isolated bleeding points or a single fine line of blood appear.
- The interdental triangle fills with blood shortly after probing.
- 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).
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)
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.
- First posted2 Mar 2026
- Study start6 May 2023
- Primary completion22 Dec 2024
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class II, Division 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mudar Mohammad Mousa, DDS, MSc, Principal investigator, Department of Orthodontics, Faculty of Dentistry, University of DamascusMohammad Younis Hajeer, DDS, MSc, PhD, Study chair, Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus
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 27696311Al-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 23787192Mousa 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 38131681Mousa 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 40353446Khlef 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 33158633Al-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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07442825
- Acronym / sponsor ID
- UDDS-2026-Ortho-02
- Conditions
- Malocclusion, Angle Class II, Division 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The FC+LLLT Group | Experimental | Procedure: Level Laser Therapy (LLLT)Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) and subsequent low-level laser therapy (LLLT). |
| The FC Group | Experimental | Procedure: Flapless Corticotomy (Piezocision)Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) alone |
| The control group | Active comparator | Procedure: Traditional treatmentParticipants in this arm receive conventional en-masse retraction with no surgical or laser adjuncts |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flapless Corticotomy (Piezocision)Performed 4 days before retraction. Eighteen minimal intrasulcular incisions and cortical bone perforations (3mm depth) using a piezosurgery microsaw tip. | Procedure or surgery | The FC Group |
| Level Laser Therapy (LLLT)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. | Procedure or surgery | The FC+LLLT Group |
| Traditional treatmentPatients in this group will be traditionally treated without being subjected to corticotomy or LLLT. | Procedure or surgery | The control group |
Primary outcome
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 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).
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).
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.
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).
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.
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).
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.
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).
This will be measured in millimeters from the cement-enamel junction to the gingival margin level around the six anterior teeth
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 27696311Alfawal 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.
- Background: PubMed 23787192Al-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.
- Background: PubMed 38131681Mousa 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.
- Background: PubMed 40353446Mousa 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.
- Background: PubMed 33158633Khlef 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.
- Background: PubMed 34688577Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mudar Mohammad Mousa, DDS, MSc principal investigator
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Mohammad Younis Hajeer, DDS, MSc, PhD study chair
Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus
1 site in 1 country: see every site and its status.
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.