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Trial registered on ANZCTR


Registration number
ACTRN12617000128392
Ethics application status
Approved
Date submitted
3/01/2017
Date registered
24/01/2017
Date last updated
18/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of air polishing with erythritol powder in the treatment of chronic periodontitis
Scientific title
Effect of air polishing with erythritol powder in the treatment of chronic periodontitis
Secondary ID [1] 290829 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12615000065594

Health condition
Health condition(s) or problem(s) studied:
Chronic periodontitis 301502 0
Condition category
Condition code
Oral and Gastrointestinal 301213 301213 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
A trained periodontist and a periodontics registrar will undertake the procedures and examination. Both have a Bachelor of Dental Surgery and one holds a Masters in Periodontics.

Baseline 2 x 60mins
Pre-study treatment will occur over 2 appointments and involves the consent procedure as well as alginate impressions and radiography (panoramic or periapical as suitable for the patient)

Periodontal treatment will occur over 2 sessions for each patient at the following next available times (2x 60 mins)
Use of "air polishing", compressed air with erythritol powder, in combination with ultrasonic and hand instrumentation (EMS ultrasonic scaler, Hu-Friedy Gracey and Universal Currettes) in the initial treatment and supportive treatment of periodontitis

Recall will occur at 3 months (1x60mins) where supportive periodontal therapy will occur and clinical and microbiological measurements

No adherence measurements will be undertaken, though a record of treatment is always kept for assessment.
Intervention code [1] 296750 0
Treatment: Other
Comparator / control treatment
split mouth design comparator of ultrasonic and hand instrumentation in the initial treatment and supportive treatment of periodontitis
Control group
Active

Outcomes
Primary outcome [1] 300626 0
periodontal probing depths - measured with Florida probe at the review session at 3 months from the last periodontal treatment session
Timepoint [1] 300626 0
3 months from the last periodontal treatments session
Secondary outcome [1] 330437 0
microbiology counts - measured total bacterial counts from plaque samples obtained from the subject's periodontium using paper points #30 around the deepest periodontal pocket per quadrant for the patient, polymerase chain reaction is used for microbial analysis
Timepoint [1] 330437 0
baseline, immediately after periodontal treatment treatment, 1 week, 1 month, 3 months, 6 months post final periodontal treatment

Eligibility
Key inclusion criteria
Patients with mild or moderate generalised chronic periodontitis
Approximal Plaque Index less than 40%, Sulcus Bleeding Index less than 30%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years old
systematic conditions which may influence the periodontal disease
pregnancy
smokers
language other than English (booking of interpreters unfeasible)

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)
not applicable as this is a split mouth design - all patients receive both treatment on one side of the mouth and control treatment on the other side of the mouth
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Participants are selected based on having similar affected sites in opposite sides of the mouth and thereby receive both treatments, one on each side, in a split-mouth study

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2018
Actual
Date of last participant enrolment
Anticipated
24/02/2018
Actual
Date of last data collection
Anticipated
21/09/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7185 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 14947 0
2010 - Surry Hills
Recruitment postcode(s) [2] 14948 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 295253 0
Hospital
Name [1] 295253 0
Sydney Dental Hospital - Periodontics Department
Country [1] 295253 0
Australia
Primary sponsor type
Hospital
Name
Sydney Dental Hospital
Address
2B Chalmers St
Surry Hills
NSW 2010
Country
Australia
Secondary sponsor category [1] 294081 0
None
Name [1] 294081 0
none
Address [1] 294081 0
none
Country [1] 294081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296591 0
Royal Prince Alfed Hospital
Ethics committee address [1] 296591 0
Ethics committee country [1] 296591 0
Australia
Date submitted for ethics approval [1] 296591 0
25/11/2016
Approval date [1] 296591 0
16/12/2016
Ethics approval number [1] 296591 0
X16-0445

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

Contacts
Principal investigator
Name 71410 0
Dr Harold Pradhaan
Address 71410 0
Periodontics Department
Sydney Dental Hospital
2B Chalmers St
Surry Hills
NSW 2010
Country 71410 0
Australia
Phone 71410 0
+61292933200
Fax 71410 0
Email 71410 0
harold.pradhan@health.nsw.gov.au
Contact person for public queries
Name 71411 0
Harold Pradhan
Address 71411 0
Periodontics Department
Sydney Dental Hospital
2B Chalmers St
Surry Hills
NSW 2010
Country 71411 0
Australia
Phone 71411 0
+61292933200
Fax 71411 0
Email 71411 0
harold.pradhan@health.nsw.gov.au
Contact person for scientific queries
Name 71412 0
Harold Pradhan
Address 71412 0
Periodontics Department
Sydney Dental Hospital
2B Chalmers St
Surry Hills
NSW 2010
Country 71412 0
Australia
Phone 71412 0
+61292933200
Fax 71412 0
Email 71412 0
harold.pradhan@health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.