NCT07442825

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 17 Years – 28 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Flapless Corticotomy (Piezocision)	Performed 4 days before retraction. Eighteen minimal intrasulcular incisions and cortical bone perforations (3mm depth) using a piezosurgery microsaw tip.
PROCEDURE	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	Traditional treatment	Patients in this group will be traditionally treated without being subjected to corticotomy or LLLT.

Timeline

• Start date: 2023-05-06
• Primary completion: 2024-12-22
• Completion: 2025-03-18
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: Syria