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Trial registered on ANZCTR


Registration number
ACTRN12611001099910
Ethics application status
Approved
Date submitted
18/10/2011
Date registered
21/10/2011
Date last updated
21/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pulsed Nd:YAG (He:Ne) Laser Induction of Pulpal Analgesia on young patients requiring paired bilateral premolar tooth extraction: A Randomised, double-blinded and Comparative Clinical Trials.
Scientific title
Pulsed Nd:YAG (He:Ne) Laser Induction of Pulpal Analgesia on young patients requiring paired bilateral premolar tooth extraction: A Randomised, double-blinded and Comparative Clinical Trials.
Secondary ID [1] 273229 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthetics 278989 0
Pain Management 278990 0
Condition category
Condition code
Anaesthesiology 279172 279172 0 0
Pain management
Oral and Gastrointestinal 279185 279185 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
1) A pulsed Nd:YAG Laser (The American Dental Laser, Sunrise technologies Inc., California, USA., model, dLase300)had an emission wavelength of 1064nm, at 150 microsceond pulse duration. The mean average power of 1.1+ 0.2W, 15Hz; 60-87mJ energy pulse; energy density: 73-107J/cm2; total energy: 211- 312J.
2)0.5mg of 5% EMLA cream (2.5% lignocaine and 2.5% prilocaine), was applied to the buccal mucosa via a plastic syringe and secured in place with oral bandage for 20mins.
These two interventions happen during the same, single session.

For each subject, a pair of bilateral premolar teeth was randomly allotted as i) the Laser plus Sham EMLA or ii) Sham Laser plus EMLA groups by an independent person who neither operated the Laser nor tested the analgesic effects. Analgesia was assessed by cutting a standardised-cavity and recorded by EPT and carried out by an operator not applying Laser nor assessing the VAS score.

The sham EMLA participants will always receive the real-Laser. And the the real-EMLA participatants will always receive the sham-Laser

Subjects wore ear headphones with no sound and Laser-protective goggles to maintain double-blindedness and for safety. Baseline EPT was measured and recorded prior to treatment. The buccal sulcus adjacent to the test tooth was dried, and 0.5mg of EMLA or Sham EMLA cream applied via a syringe, secured and isolated with an Orahesive bandage (Convatec, Victoria, Australia).

15 minutes after EMLA or Sham EMLA sulcular application, Laser or Sham Laser, was applied in a focus (1mm away) scanning-motion at 3mm/sec over cervical half of the buccal and the lingual/palatal tooth surfaces to a total of 240sec (120sec/surface) and the EPT reading recorded immediately. After five minutes, a standardised cavity was cut at the cervical half of the buccal surface with a high-speed-diamond-bur. Subjects indicated sensitivity by raising their hand and drilling and EPT recording terminated immediately and VAS (0-100mm) recorded.
Intervention code [1] 269561 0
Treatment: Devices
Intervention code [2] 269562 0
Treatment: Drugs
Comparator / control treatment
1)Sham laser (1mW, He:Ne laser aiming beam).
2)Sham EMLA consisted of the cream ingredients with no EMLA. Both creams were prepacked and coded by Astra Pharmaceuticals (NSW, Australia).
Control group
Placebo

Outcomes
Primary outcome [1] 279808 0
The study showed a mean increase of 10.1 EPT units for the Laser group compared with 11.7 EPT units for the EMLA group. 81% receiving either Laser or EMLA treatment showed increased in EPT readings from the baseline. The paired-t Test showed a statistically significant increase in pain thresholds assessed by EPT after Laser or EMLA treatment
Timepoint [1] 279808 0
Electric pulp testing was carried out to assess the analgesic effects immediately after the application of the intervention.
Secondary outcome [1] 294493 0
Thirty cavities (68%) were completed in the Laser group and twenty-six (59%) in the EMLA group. Where cavities were not completed, VAS scores were 22+21/100mm for the Laser group and 23+18/100mm for the EMLA group.
Timepoint [1] 294493 0
Cutting a standardised cavity on the test tooth to assess the analgesic effects immediately after the application of the intervention. The assessment was terminated when the subject first felt sensitivity. VAS scores were then recorded.

Eligibility
Key inclusion criteria
Orthodontic young patients who required a paired bilateral premolar tooth extraction from either dental arch. All teeth were vital, restoration and caries-free with good periodontal health. Subjects had good health.
Minimum age
14 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects have history of allergy to local anaesthetic or have pacemakers, hearing aids and other attached electronic devices were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270059 0
Self funded/Unfunded
Name [1] 270059 0
Ambrose Chan
Address [1] 270059 0
Shop1, 28 President Ave
Caringbah, NSW 2229
Country [1] 270059 0
Australia
Primary sponsor type
Individual
Name
Ambrose Chan
Address
Shop1, 28 President Ave
Caringbah, NSW 2229
Country
Australia
Secondary sponsor category [1] 269023 0
University
Name [1] 269023 0
University of Sydney
Address [1] 269023 0
Westmead Hospital Dental
POBox 533
Wentworthville, NSW2145
Weatmead
Country [1] 269023 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272016 0
NSW Health Human Research Westmead Hospital Ethics Committee.
Ethics committee address [1] 272016 0
Westmead Hospital Ethics Committee
Loked Bag 4001
Weatmead, NSW 2145
Ethics committee country [1] 272016 0
Australia
Date submitted for ethics approval [1] 272016 0
08/02/1993
Approval date [1] 272016 0
08/08/1993
Ethics approval number [1] 272016 0
#HREC/93/8/4.2

Summary
Brief summary
This randomised, double-blind and standardised clinical trials investigated the clinical effectiveness of pulsed Nd:YAG Laser induction of pulpal analgesia compared with 5% EMLA The current study strengthens other reports of the clinical effectiveness of Nd:YAG Laser induction of pulpal analgesia in a carefully planned and standardised, blinded controlling manner. Further studies are however needed to define the optimal Laser parameters, the reversibility of the analgesic effect and the follow-up induced changes on tooth morphology and the pulp for Laser-induced pulpal analgesia. Of particular significance is that Laser-induced pulpal analgesia is effective, minimally invasiveness and therefore, has significant implications world-wide particularly in underdeveloped countries. anaesthetic cream.
Trial website
Trial related presentations / publications
NIL
Public notes

Contacts
Principal investigator
Name 33279 0
Address 33279 0
Country 33279 0
Phone 33279 0
Fax 33279 0
Email 33279 0
Contact person for public queries
Name 16526 0
Ambrose Chan
Address 16526 0
Shop1, 28 President Ave
Caringbah, NSW 2228
Country 16526 0
Australia
Phone 16526 0
612-95262090
Fax 16526 0
612-97036899
Email 16526 0
ambrose.chan@sydney.edu.au
Contact person for scientific queries
Name 7454 0
Ambrose Chan
Address 7454 0
Shop1, 28 President Ave
Caringbah, NSW 2228
Country 7454 0
Australia
Phone 7454 0
612-95262090
Fax 7454 0
612-97036899
Email 7454 0
ambrose.chan@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary