None listed
Conditions
Brief summary
This prospective randomised controlled trial, employing a split-mouth design, aims to investigate the impact of low-level laser therapy (LLLT) on the repair of root resorption in first premolars subjected to bite-raising forces. Conducted at the Department of Orthodontics at Sydney Dental Hospital, the study will recruit participants requiring extraction of all four first premolars for orthodontic treatment. One side of the mouth will receive a sham laser while the contralateral side will be treated with LLLT. Pain experiences will be evaluated using a Visual Analogue Scale, and pulp vitality will be tested throughout the laser therapy. Post-extraction, micro-computed tomography will be utilised to measure the surface volume of resorption. This approach aims to provide quantitative insights into the effects of LLLT on root resorption and cemental repair, offering potential implications for orthodontic treatments.
Interventions
Low level laser therapy with a 650nm diode laser will be used to investigate the effect on pain and the development of root resorption on teeth with orthodontic adhesive bite raisers.
This study will employ a split mouth design with a true and sham laser.
A 650nm soft tissue diode laser (Wuhan Pioon Technology Co Ltd; Wuhan, China) will be used in this study. The sham laser will emit a light beam.
The application protocol will be as described by Ng et al. (2018). There will be 8 points of contac
Low level laser therapy with a 650nm diode laser will be used to investigate the effect on pain and the development of root resorption on teeth with orthodontic adhesive bite raisers. This study will employ a split mouth design with a true and sham laser. A 650nm soft tissue diode laser (Wuhan Pioon Technology Co Ltd; Wuhan, China) will be used in this study. The sham laser will emit a light beam. The application protocol will be as described by Ng et al. (2018). There will be 8 points of contact, with 4 on the buccal side, and 4 on the palatal/lingual side on the mucosa directly above the root surface of each tooth. These will consist of 2 points at the cervical portion (mesial and distal), 1 at midroot, and 1 at the apex of the tooth per buccal and palatal/lingual sides. The application points aim to cover the periodontal fibers and alveolar process around the first premolar teeth. Each application will be 15 seconds with a total treatment time of 2 minutes. A continuous beam will used. The laser tip will be held perpendicularly contacting the gingival mucosa during the laser irradiation. Eye protection of the patient, operator, and dental assistants will be ensured by wearing laser safety glasses. The laser therapy will be administered by orthodontic registrars. The procedure will take place at in the treatment rooms at the Sydney Dental Hospital, Orthodontics Department located at 2 Chalmers Street, Surry Hills, New South Wales, Australia 2010. Bite raisers will be placed with light-cured glass ionomer cement (Transbond Plus Light Cure Band Adhesive; 3M Unitek, Monrovia, Calif) onto the occlusal surface of the mandibular first premolar so that the cement was in contact with the maxillary first premolar. The thickness of this cement will be adjusted to 2 mm between the buccal cusp tips of both first premolars. The bite raisers will remain in place for 28 days to induce root resorption. After 28 days of placement of the bite raisers, they will be removed and the retention phase will start. 018 Stainless Steel wires will be bonded to the premolars and 1 adjacent tooth on both sides as a fixed retainer. A sham laser and true laser will be applied to each side on day 0, 7, 14, 21 after removal of the bite raisers. The teeth will be extracted on Day 28 of bite raiser removal (1 week after the last day of laser administration).
Sponsors
Australian Society of Orthodontists Foundation for Research and Education
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: • Indicated for extraction of all first premolars (four teeth) as part of an orthodontic management plan, where the first premolars are in occlusion with each other. • Permanent dentition • Complete apexification of the first premolar teeth • Similar degree of minimal crowding • Absence of previous orthodontic and/or orthopaedic treatment. • No craniofacial or dental anomalies, no missing teeth • No previous observed or reported dental treatment involving the first premolars • No history of trauma, bruxism or parafunction • No past or present signs of periodontal disease • Maintenance of overall health with no significant medical history or medication that would affect the dentition.
Exclusion criteria
• Patient or parent declining participation or unable to give informed consent • Poor patient compliance or cooperation that compromises data collection • As the following medication (s) can have interactive effects and may interfere with the participant’s ability to meet study requirements, patients who are taking: o Long term systemic steroids o Long term systemic analgesics or anti-inflammatories
Outcome results
None listed