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Trial registered on ANZCTR


Registration number
ACTRN12615000065594
Ethics application status
Not yet submitted
Date submitted
11/11/2014
Date registered
23/01/2015
Date last updated
23/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of subgingival Air Polishing using Erythritol Powder in Periodontitis patients during Supportive Periodontal Therapy (SPT)
Scientific title
Effect of Air Polishing using Erythritol Powder versus conventional ultrasonic and hand scaling on the resolution of residual periodontal pockets and patient comfort during treatment in patients with chronic periodontitis undergoing maintenance therapy
Secondary ID [1] 285631 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Periodontitis 293474 0
Condition category
Condition code
Oral and Gastrointestinal 293755 293755 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 293911 293911 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of air polishing with an erythritol powder, using a small nozzle to go into the gums, a water jet/slurry with the powder is applied in order to remove plaque.
a)Duration of the treatment is approximately 10 minutes
b)Conducted at baseline and repeated at 3 months
Intervention code [1] 290579 0
Treatment: Other
Comparator / control treatment
The use of conventional ultrasonic scaling in patients with chronic periodontitis receiving maintenance therapy
a) Duration of treatment approximately 10 minutes
b) Conducted at baseline and repeated at 3 months
Control group
Active

Outcomes
Primary outcome [1] 293557 0
Periodontal probing pocket depths as assessed by an electronic periodontal probe (Florida probe) with automated force application for reproducibility
Timepoint [1] 293557 0
Assessed at baseline, 1 week after treatment, then at 1 month, 3 months and 6 months.
Primary outcome [2] 293688 0
Bleeding on probing as assessed by the number of sites with spot bleeding within 15 seconds following periodontal probing
Timepoint [2] 293688 0
Assessed at baseline, 1 week after treatment, then at 1 month, 3 months and 6 months.
Secondary outcome [1] 311350 0
Bacterial counts prior to and post treatment in the two groups.
Assessed by using a paper point placed into the periodontal pocket for approximately 15 seconds and measured using real-time PCR
Timepoint [1] 311350 0
At baseline, immediately after treatment, at 1 week, 1 month, 3 months and 6 months

Eligibility
Key inclusion criteria
1.Patient with a mild or moderate chronic periodontitis and completed initial periodontal therapy (SRP)
2. Approximal Plaque index (API) less than or equal to 40% (used to assess oral hygiene)
3. Sulcus Bleeding Index (SBI) less than or equal to 25% (used to assess ginigival inflammation)
4. A minimum of two pockets at similar single-rooted teeth in contralateral jaw with similar Probing pocket depths (PPD) of 5mm or greater (+/- 1mm) and bleeding on probing at the site
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pockets with PPDs < 5mm, API > 40%, SBI > 25% (poor oral hygiene)
2. Multi-rooted teeth (molars)
3. Patients below an age of 18
4. Patients with a risk of endocarditis
5. Patients on bisphosphonates
6. Use of local or systemic antibiotic within the last 6 months
7. Allergy against erythritol
8. Patients with a blood coagulation disorder
9. Patients using anticoagulants
10. Patients with liver disorders
11. Patients with gastro-intestinal disorders
12. Mentally disabled patients
13. Pregnancy
14. Lactation
15. Smoker

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)
Patient is given a participant information form and consent. Allocation is concealed by a separate clinical operator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
by “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
Other
Other design features
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
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2015
Actual
Date of last participant enrolment
Anticipated
1/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3137 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 8886 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 290222 0
Hospital
Name [1] 290222 0
Sydney Dental Hospital - Department of Periodontics (internal funding)
Country [1] 290222 0
Australia
Primary sponsor type
Hospital
Name
Sydney Dental Hospital- Head of Department Periodontics
Address
2 Chalmers St
Surry Hills
2010 NSW Australia
Country
Australia
Secondary sponsor category [1] 288933 0
Individual
Name [1] 288933 0
Sal Shahidi
Address [1] 288933 0
Sydney Dental Hospital
2 Chalmers St
Surry Hills
2010 NSW
Country [1] 288933 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291926 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 291926 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 291926 0
Australia
Date submitted for ethics approval [1] 291926 0
20/08/2014
Approval date [1] 291926 0
Ethics approval number [1] 291926 0
EC00113

Summary
Brief summary
Periodontitis is a chronic infection, which is mainly associated with Gram-negative bacteria. The aim of the systematic periodontal therapy is to reduce the number of periodontal pathogens to avoid a further progression of the disease, thus to avoid further attachment/bone loss. Systematic periodontal therapy involves, after completion of the initial hygiene phase, debridement of the exposed root surfaces by means of scaling and root planning (SRP). However, some periodontal pathogens have shown to be very resistant to the conventional treatment of periodontitis: SRP and/or surgical periodontal therapy. Even the additional use of systemic and/or local antibiotics has not been able to completely eliminate the pathogens or to maintain periodontal health over a longer period of time so far.
In recent times a novel approach, the so called Air Polishing (Ap) has been developed for the removal of subgingival biolfim during SPT with the use a fine powder delivered via a commercially available injection abrasive water jet. Due to the small particle sizes of the powder the damage to the root surfaces compared to sonic, piezoelectric ultrasonic and magnetoconstrictive ultrasonics, is considerably lower.
The aim of this study is to investigate whether an adjunct use of a recently introduced Erythritol Powder (Ep) could further improve the clinical and/or microbiological parameters in patients with a mild or moderate type of chronic periodontitis who already received initial therapy (SRP) but are still showing probing pocket depths (PPD) of greater than, or equal to 5mm including bleeding on probing (BOP).
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 234 234 0 0
/AnzctrAttachments/367403-Study_Design_Air-Flow Therapy Proposal 2.doc
Attachments [2] 235 235 0 0
/AnzctrAttachments/367403-Information for Participants.doc
Attachments [3] 236 236 0 0
/AnzctrAttachments/367403-TRACKED-ETHICS APPLICATION FORM FOR RESEARCH INVOLVING HUMANS.doc

Contacts
Principal investigator
Name 52670 0
A/Prof Axel Spahr
Address 52670 0
Sydney Dental Hospital
2 Chalmers St
Surry Hills 2010
NSW
Country 52670 0
Australia
Phone 52670 0
+61 2 9293 3274
Fax 52670 0
Email 52670 0
axel.spahr@sswahs.nsw.gov.au
Contact person for public queries
Name 52671 0
Sal Shahidi
Address 52671 0
Sydney Dental Hospital
2 Chalmers St
Surry Hills 2010
NSW
Country 52671 0
Australia
Phone 52671 0
+61 2 9293 3274
Fax 52671 0
Email 52671 0
salshahidi@me.com
Contact person for scientific queries
Name 52672 0
Sal Shahidi
Address 52672 0
Sydney Dental Hospital
2 Chalmers St
Surry Hills 2010
NSW
Country 52672 0
Australia
Phone 52672 0
+61 2 9293 3274
Fax 52672 0
Email 52672 0
salshahidi@me.com

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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