Orthodontics Department, Faculty of Dentistry
Damascus, Syrian Arab Republic, DM20AM19, Syria
NCT Number: NCT07442825
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.
Looking for future studies?
Notify Me17 year–28 year
All sexes
Interventional
Not applicable
Damascus, Syrian Arab Republic, DM20AM19, Syria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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:
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.
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.
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
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 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.
Damascus University
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07259720
Malocclusion, Malocclusion, Angle Class II
Cairo, Egypt
View Trial DetailsNCT06403033
Malocclusion, Malocclusion, Angle Class II
Damascus, Syria
View Trial DetailsNCT05610150
Malocclusion, Malocclusion, Angle Class II
Alexandria, Egypt
View Trial DetailsNCT03659188
Malocclusion, Malocclusion, Angle Class II
Damascus, Syria
View Trial Details