An interventional study of Flapless Corticotomy (Piezocision) and Level Laser Therapy (LLLT) in Malocclusion, Angle Class II, Division 1, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 17 Years to 28 Years. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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.
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's enrollment of 66 is above the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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)
Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) alone
Procedure: Flapless Corticotomy (Piezocision)
Participants in this arm receive conventional en-masse retraction with no surgical or laser adjuncts
Procedure: Traditional treatment
Performed 4 days before retraction. Eighteen minimal intrasulcular incisions and cortical bone perforations (3mm depth) using a piezosurgery microsaw tip.
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.
Patients in this group will be traditionally treated without being subjected to corticotomy or LLLT.
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).
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).
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.
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).
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.
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).
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.
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).
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
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).
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.
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).
Plan to share: No
Ran from May 2023 to primary completion in Dec 2024, 19 months.
Of 86 non-industry interventional studies with no phase under Malocclusion, Angle Class II, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's 19 months is above that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 11 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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