Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000171516
Ethics application status
Approved
Date submitted
23/11/2023
Date registered
23/02/2024
Date last updated
23/02/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Low-Level Laser Therapy on Pain and the Development of Orthodontically Induced Inflammatory Root Resorption: A Randomised Controlled Trial with Temporary Bite Raisers
Scientific title
The Effect of Low-Level Laser Therapy on Pain and the Development of Orthodontically Induced Inflammatory Root Resorption: A Randomised Controlled Trial with Temporary Bite Raisers in Patients Requiring Extraction of All Four First Premolars for Orthodontic Treatment
Secondary ID [1] 311002 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Root Resorption 332132 0
Pain 332133 0
Pulp chamber volume 332134 0
Orthodontics 332135 0
Condition category
Condition code
Oral and Gastrointestinal 328857 328857 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 two principal investigators (both Orthodontic Registrars) will apply the laser therapy on days 0, 7, 14, 21 of bite raiser placement with either the sham or true laser to one side of the mouth.
The teeth will be extracted on Day 28 of bite raiser placement (1 week after the last day of laser administration).
Intervention code [1] 327462 0
Prevention
Comparator / control treatment
This study will be employing a split-mouth design.
The control treatment is to have orthodontic temporary bite raisers without low level laser therapy.
A 650nm soft tissue diode laser (Wuhan Pioon Technology Co Ltd; Wuhan, China) will be used in this study. The laser device has a placebo setting where the sham laser will emit a light beam.
The application protocol for the sham laser 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.

The sham 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 two principal investigators (both Orthodontic Registrars) will apply the sham laser therapy on days 0, 7, 14, 21 after placement of the bite raisers.
The teeth will be extracted on Day 28 of bite raiser placement (1 week after the last day of laser administration).
Control group
Placebo

Outcomes
Primary outcome [1] 336657 0
Root resorption
Timepoint [1] 336657 0
28 days after treatment
Primary outcome [2] 336658 0
Pain
Timepoint [2] 336658 0
Day 0 (treatment commences, 7, 21, 28 (after treatment).
Secondary outcome [1] 429191 0
Pulp chamber volume
Timepoint [1] 429191 0
Day 28 (after treatment)

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be accomplished using a remote computerised random number generator by the supervisor of the project who is not involved in conducting the study. Each patient will be randomly allocated either the right or left side to be the experimental laser side and the contralateral side to the control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Wilcoxon signed rank test will be used for the comparison of root resorption values between the sham laser and laser groups, and between the maxilla and the mandible (P\0.05). The Friedman (P\0.05) and Wilcoxon (P\0.0083) tests will be applied to determine the significant differences among the root surfaces and the vertical thirds. The Pearson correlation coefficient will be used to evaluate possible correlations between age, sex, volume of the root resorption craters, and pain. P <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
20/05/2024
Actual
Date of last data collection
Anticipated
11/11/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25881 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 41714 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 315265 0
Hospital
Name [1] 315265 0
Sydney Local Health District, Sydney Dental Hospital
Country [1] 315265 0
Australia
Primary sponsor type
Other
Name
Australian Society of Orthodontists Foundation for Research and Education
Address
21 / 119 Willoughby Rd Crows Nest NSW 2065
Country
Australia
Secondary sponsor category [1] 317318 0
None
Name [1] 317318 0
Address [1] 317318 0
Country [1] 317318 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314185 0
SLHD RPA Research Ethics and Governance Office (REGO)
Ethics committee address [1] 314185 0
Ethics committee country [1] 314185 0
Australia
Date submitted for ethics approval [1] 314185 0
23/11/2023
Approval date [1] 314185 0
06/02/2024
Ethics approval number [1] 314185 0
Ethics committee name [2] 314676 0
Research Ethics and Governance Office Royal Prince Alfred Hospital
Ethics committee address [2] 314676 0
Ethics committee country [2] 314676 0
Australia
Date submitted for ethics approval [2] 314676 0
Approval date [2] 314676 0
Ethics approval number [2] 314676 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130710 0
Prof Ali Darendeliler
Address 130710 0
Department of Orthodontics, Sydney Dental Hospital, 2 Chalmers St, Surry Hills, NSW 2010
Country 130710 0
Australia
Phone 130710 0
+61412231116
Fax 130710 0
Email 130710 0
[email protected]
Contact person for public queries
Name 130711 0
Natasha Paul
Address 130711 0
Department of Orthodontics, Sydney Dental Hospital, 2 Chalmers St, Surry Hills, NSW 2010
Country 130711 0
Australia
Phone 130711 0
+61 493619844
Fax 130711 0
Email 130711 0
[email protected]
Contact person for scientific queries
Name 130712 0
Natasha Paul
Address 130712 0
Department of Orthodontics, Sydney Dental Hospital, 2 Chalmers St, Surry Hills, NSW 2010
Country 130712 0
Australia
Phone 130712 0
+61 493619844
Fax 130712 0
Email 130712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial IPD will not be shared to protect patient confidentiality and consent. Patients are part of the Sydney Dental Hospital and form a vulnerable population group.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21328Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.