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

D

Damascus University

Status

Completed

Conditions

Malocclusion, Angle Class II, Division 1

Treatments

Procedure: Traditional treatment
Procedure: Level Laser Therapy (LLLT)
Procedure: Flapless Corticotomy (Piezocision)

Study type

Interventional

Funder types

Other

Identifiers

NCT07442825
UDDS-2026-Ortho-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

17 to 28 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Healthy patients aged 17-28 years.
  2. 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)
  3. A skeletal Class II relationship, confirmed by a cephalometric ANB angle between 4° and 7°
  4. An overbite of 0%-33%
  5. Good oral hygiene, defined by a probing depth of ≤3 mm and no radiographic evidence of alveolar bone loss
  6. Absence or a mild level of crowding
  7. A full complement of teeth, excluding third molars.

Exclusion criteria

  1. A history of previous orthodontic treatment
  2. Any systemic disease or medication known to interfere with orthodontic tooth movement.
  3. Congenitally missing or extracted teeth in the maxilla (except third molars)
  4. Poor oral hygiene,
  5. Active periodontal disease (probing depth ≥4 mm, radiographic bone loss, gingival index >1, plaque index >1)
  6. Moderate to severe maxillary crowding (Little's Irregularity Index ≥4).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 3 patient groups

The FC+LLLT Group
Experimental group
Description:
Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) and subsequent low-level laser therapy (LLLT).
Treatment:
Procedure: Level Laser Therapy (LLLT)
The FC Group
Experimental group
Description:
Participants in this arm receive en-masse retraction assisted by flapless corticotomy (piezocision) alone
Treatment:
Procedure: Flapless Corticotomy (Piezocision)
The control group
Active Comparator group
Description:
Participants in this arm receive conventional en-masse retraction with no surgical or laser adjuncts
Treatment:
Procedure: Traditional treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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