NCT05656898

Evaluation of the Levels of Pain and Discomfort and Periodontal Status Between Two Acceleration Methods of Upper Anterior Teeth Retraction

Completed NA Last updated 29 September 2023

What this trial tests

NA trial testing Piezocision+GaALAs diode laser in Class II Malocclusion in 60 participants. Completed in 15 May 2023.

Timeline

9 February 2021

Primary endpoint
2 December 2022

15 May 2023

Quick facts

Lead sponsor	Damascus University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	9 February 2021
Primary completion	2 December 2022
Estimated completion	15 May 2023
Sites	1 location across Syria

Drugs / interventions tested

• Piezocision+GaALAs diode laser
• Piezocision
• Orthodontic fixed appliance

Conditions studied

• Class II Malocclusion — all drugs for Class II Malocclusion →

Sponsor

Damascus University

Who can join

Adults 17 to 28, any sex, with Class II Malocclusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

60 patients will be treated by extraction of maxillary first premolars by applying mini-screws between the maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). They will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Mousa MM, Hajeer MY, Burhan AS, Darwich KMA, et al · · 2023 · cited 9× · PMID 38131681 · DOI 10.3390/clinpract13060132