RecruitingACTRN12616000682448

The effect or LLLT (low level laser therapy) on repair of root resorption undergoing bilateral first pre-molar extraction.

Sponsor

Sydney University

Enrollment

20 participants

Start Date

Jan 9, 2017

Study Type

Interventional

Conditions

Root resorption (related to orthodontic treatment)Tooth crowding

Summary

Root resorption defects as a sideffect of orthodontic treatment. The aim of this study is to compare whether a lower level laser operated in a stimulatory mode has an effect on the rate of healing of root resorption defects associate with routine orthodontic tooth movement. The first part consists of applying buccally directed (towards the cheek) orthodontic forces to the upper 1st premolars to simulate orthodontic tooth movement. After 1 month, all force will be removed and the teeth retained passively to allow the natural process of root resorption repair following orthodontic tooth movement to occur. During this period, laser will be applied to one side of the mouth whilst a sham laser (no laser energy) will be used on the control side. After another month, premolars on both sides of the mouth (laser treated and controls) will be extracted and analysed with a micro-ct to determine if laser has any effect on the rate of healing of orthodontic induced root resorption. Root resorption is a significant consequence of orthodontic treatment. LLLT has been used in a biostimulatory manner in the healing of soft tissue wounds, implant related infections and in oral mucositis. Findings may provide clinical evidence in relation to use of LLLT in the aid of repair of root resorption.

Eligibility

Sex: Both males and femalesMin Age: 10 YearssMax Age: 30 Yearss

Plain Language Summary

Simplified for easier understanding

This dental study is investigating whether low-level laser therapy (LLLT) — a painless light treatment — can help teeth roots heal faster after the minor damage that occurs during orthodontic (braces) treatment. Participants who are already having upper first premolar teeth removed as part of their orthodontic treatment plan will have a gentle force applied to their teeth for one month, then laser treatment on one side of their mouth only. After another month, both teeth will be removed and examined under a special microscope to measure healing. You may be eligible if: - You are between 10 and 30 years old - You need to have both upper first premolar teeth removed as part of your orthodontic treatment - All your adult teeth have fully formed roots - There is minimal crowding on both sides of your upper jaw You may NOT be eligible if: - Your treatment plan does not require removal of upper first premolars - You have had previous orthodontic treatment - You have a facial bone or jaw abnormality - You have a history of tooth trauma, teeth grinding, or gum disease - You have significant medical conditions that affect tooth development or movement Talk to your doctor about whether this trial might be right for you.

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Interventions

Method: Phase 1: orthodontic tooth movement (Duration 4 weeks) 1) Orthodontic brackets bonded to the upper first permanent molar and first premolar teeth. 2) 150g buccally directed force, applied

Method: Phase 1: orthodontic tooth movement (Duration 4 weeks) 1) Orthodontic brackets bonded to the upper first permanent molar and first premolar teeth. 2) 150g buccally directed force, applied bilaterally to the first premolars to achieve buccal tipping. 4 weeks of force application: *Using a 0.017” x 0.025” TMA (Ormco, CA) spring. *Force magnitude measured to the nearest gram with a strain gauge (Dentaurum, Germany). Phase 2: Removal of orthodontic force, Initiation of rest period, laser application (intervention) on experimental side, sham laser (no power) on control side. (Duration 6 weeks) 1) Orthodontic force is ceased 2) A fixed retainer constructed of 0.018” stainless steel will be bonded to the teeth to hold them passively in place. 3) During this period, laser will be applied to randomly assigned experimental side whilst the contralateral side serving as a control will receive the ‘sham’ laser. 4) Laser application - Experimental side. (660nm AlGaInP Laser Dental Probe, Thor Photomedicine Ltd, ARTG: 197699). *6 exposures per session. This comprises 3 points along root of the tooth (crestal, mid root, apex) for each of the buccal and palatal aspects of the tooth. * Each LLLT exposure is with a wavelength within the visible spectrum (660 nm). (Irradiance of 0.764W/cm-2 for 7 seconds which equals ~ 5.4J/cm-2 per exposure.). *Laser sessions (once per week) for 6 weeks. This was determined based on convenience to the patient and attempting to be clinically applicable. *Sham laser application on control side – no energy output (Sham setting on laser unit). Each laser dose will be 7 seconds. 6 doses will be approximately 42 seconds in total. This compromises the total active time the laser will be used per session. The approximate time of each laser appointment will be 15 minutes, however, the total active time regarding laser exposure is approximately 42 seconds as mentioned above. An orthodontic registrar will be administering the laser dosages. Strategies for compliance would be attendance at laser appointments. Phase 3: Completion of rest period, extraction of first premolars for micro-ct study (1 visit for the patient). 4) Bilateral extraction of first premolars ~6 weeks after commencement of rest/healing phase. *Analysis of teeth at Sydney Dental Hospital using a Micro-CT scanner. *Amount of root resorption repair with and without laser to be compared

Locations(1)

Sydney Dental Hospital - Surry Hills

NSW, Australia

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ACTRN12616000682448