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Trial registered on ANZCTR


Registration number
ACTRN12624000280505
Ethics application status
Approved
Date submitted
21/03/2023
Date registered
18/03/2024
Date last updated
18/03/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can air polishing enhance our management of multi-rooted teeth with advance gum disease?
Scientific title
The effect of the adjunct use of subgingival air-polishing therapy with erythritol powder during initial non-surgical periodontal therapy of mandibular molar furcation defects on horizontal and vertical periodontal attachment level.
Secondary ID [1] 309257 0
Nil known
Universal Trial Number (UTN)
U1111-1290-0221
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
periodontal disease 329413 0
Condition category
Condition code
Oral and Gastrointestinal 326357 326357 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
Adjunct use of erythritol powder air-polishing device (EPAP) in combination with conventional periodontal subgingival instrumentation (CPSI) alone during the initial non-surgical therapy of grade I, II and III furcations in patients with generalised stage II-IV periodontitis.

Treatments are to be undertaken under local anaesthesia and will be performed by a single periodontal specialist within a single appointment at a public dental clinic.

All participants will undergo full mouth CPSI according to their clinical periodontal treatment plan. This will consist of subgingival debridement using the piezo device included in the PROPHYLAXIS MASTER (AIR-FLOW® PROPHYLAXIS MASTER) followed by hand instrumentation using curettes (Hu-Friedy, Chicago, Illinois, USA). CPSI will conclude, including at subject sites, when the operator considers the surfaces sufficiently clean and free of deposits.

Participants allocated to the test group using the AIR-FLOW® PROPHYLAXIS MASTER in combination with erythritol powder (AIR FLOW® Powder PLUS, mean grain size 14um, 0.3% chlorhexidine). At the beginning of the treatment all sites in test subjects will be treated with the AIR-FLOW® handpiece using the spray-painting stroke technique. Any pocket greater than or equal to 5mm, including furcation test sites will be treated with the PERIO-FLOW® handpiece in combination with a flexible disposable nozzle (PERIO-FLOW® Nozzle) using vertical overlapping strokes for ~5 seconds per surface. Powder settings to be used are 70% (AIR-FLOW®) and 50% (PERIO-FLOW®) and the water setting will be set to 80%.

The approximate duration of the intervention will be two, 60 minute appointments. Patient dental records will be used to monitor adherence to the intervention.
Intervention code [1] 325692 0
Treatment: Devices
Comparator / control treatment
conventional periodontal subgingival instrumentation (CPSI )alone during the initial non-surgical therapy of grade I, II and III furcations in patients with generalised stage II-IV periodontitis..

Treatments are to be undertaken under local anaesthesia and will be performed by a single periodontal specialist within a single appointment at a public dental clinic.

All participants will undergo full mouth CPSI according to their clinical periodontal treatment plan. This will consist of subgingival debridement using the piezo device included in the PROPHYLAXIS MASTER (AIR-FLOW® PROPHYLAXIS MASTER) followed by hand instrumentation using curettes (Hu-Friedy, Chicago, Illinois, USA). CPSI will conclude, including at subject sites, when the operator considers the surfaces sufficiently clean and free of deposits.

The approximate duration of comparator treatment will be two, 60 minute appointments.
Control group
Active

Outcomes
Primary outcome [1] 334213 0
Change horizontal probing attachment level (HPAL) using a furcation probe.
Timepoint [1] 334213 0
Baseline and clinical examinations 3- and 6- month post-intervention.
Primary timepoint is 6 months.
Primary outcome [2] 336039 0
Change in vertical probing attachment level (VPAL) using a PCP UNC 15 (Hu-Friedy, Chicago, IL, USA) probe
Timepoint [2] 336039 0
Baseline and clinical examination 3- and 6- month post-intervention .
Primary timepoint is 6 months.
Secondary outcome [1] 419854 0
Change in relative horizontal bone level (RHBL recorded using a furcation probe.
Timepoint [1] 419854 0
Baseline and clinical examination 3- and 6- month post-intervention .
Secondary outcome [2] 419855 0
Change in mean Clinical Attachment Level (CAL) using a PCP UNC 15 (Hu-Friedy, Chicago, IL, USA) probe
Timepoint [2] 419855 0
Baseline and clinical examination 3- and 6- month post-intervention .
Secondary outcome [3] 419856 0
Change in bleeding on probing using a PCP UNC 15 (Hu-Friedy, Chicago, IL, USA) probe
Timepoint [3] 419856 0
Baseline and clinical examination 3- and 6- month post-intervention .
Secondary outcome [4] 419857 0
Change in the ratio of keystone periodontal pathogen P.gingivalis 16s/universal 16s will be performed following collection of subgingival biofilm samples using a sterile paper point and real-time PCR (qPCR)
Timepoint [4] 419857 0
pre-treatment and immediately post-treatment, and 1 week, 1 month, 3 month and 6 month post-intervention
Secondary outcome [5] 426591 0
Change in relative vertical bone level (RVBL) recorded using a PCP UNC 15 (Hu-Friedy, Chicago, IL, USA) probe.
Timepoint [5] 426591 0
Baseline and clinical examination 3- and 6- month post-intervention .
Secondary outcome [6] 426592 0
Change in mean Periodontal Probing Depth (PPD) using a Florida Probe (Florida Probe Corporation, Gainesville, Florida, USA).
Timepoint [6] 426592 0
Baseline and clinical examination 3- and 6- month post-intervention .

Eligibility
Key inclusion criteria
1. Patients with generalised periodontitis stage II, III and/or IV with affected furcations (horizontal grade I, II and III) in mandibular first and second molars (must be vital teeth).
2. Age range: greter than or equal to 18 years.
3. Patients in good systemic health (ASA class 1 and 2).
4. Willingness to provide informed consent and willingness to participate and comply with the study requirements and protocol.
5. Patients who have not been treated for periodontal diseases in the previous 6 months and who are not currently receiving/undergoing periodontal therapy.
6. Patients that are not currently involved in periodontal supportive program (SPT).
7. Women of childbearing potential who are using a reliable contraceptive method(s).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
2. Participants currently experiencing psychological illness or other conditions which may interfere with their ability to understand the study requirements or interfere with their motivation to participate in the study.
3. Participants with a history of active periodontal treatment (subgingival instrumentation) in the previous 6 months.
4. Participants who have taken antibiotics within the past 3 months.
5. Patients taking non-steroidal anti-inflammatory medications or those who were on these medications in the past 4 weeks.
6. Patients who received any acute treatment or had acute diseases in previous 4 weeks.
7. Participants with a history of any serious and uncontrolled systemic diseases (ASA class 3-6).
8. Participants on supportive periodontal therapy.
9. Participants unable to obtain sufficient level of oral hygiene for successful treatment outcomes

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this a novel study, a number of similar studies investigating non-surgical interventions in the management of furcation defects were reviewed prior to sample size calculation, A parallel-arm randomised control trial on the adjunct use of photodynamic therapy in the management of class II furcation defects determined a minimum sample size of 16 patients which was calculated using P<0.05 and 80% power with standard deviation of 1mm (Luchesi et al. 2013). The primary outcome achieved 0.86 power value following analysis of the data. For the present study the R package “pwr” was used for power and sample size calculations. A sample size of 20 furcations per treatment group will detect a small, standardised difference with 98.86% power at a p<0.05 significance level using rm-ANOVA. To fulfill the required 20 furcations per treatment group, 20 participants will be enrolled per treatment group (total subject n=40). This will account for dropouts (estimated at 10%) as it is expected each subject diagnosed with generalised stage II-IV is likely to have greater than or equal to one furcation site suitable for the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/02/2024
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24311 0
Sydney Dental Hospital - Surry Hills
Recruitment hospital [2] 24312 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 39865 0
2010 - Surry Hills
Recruitment postcode(s) [2] 39866 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 313447 0
University
Name [1] 313447 0
University of Sydney Dental School
Country [1] 313447 0
Australia
Funding source category [2] 313448 0
Hospital
Name [2] 313448 0
Sydney Dental Hospital
Country [2] 313448 0
Australia
Funding source category [3] 313449 0
Hospital
Name [3] 313449 0
Westmead Centre for Oral Health
Country [3] 313449 0
Australia
Primary sponsor type
Individual
Name
Tihanna Divnic-Resnik
Address
University of Sydney Dental School , 2 Chalmers St, Surry Hills NSW 2010
Country
Australia
Secondary sponsor category [1] 315221 0
Individual
Name [1] 315221 0
Muhammad Jawad Khan
Address [1] 315221 0
University of Sydney 2 Chalmers St, Surry Hills NSW 2010
Country [1] 315221 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312652 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 312652 0
RESEARCH ETHICS AND GOVERNANCE OFFICEROYAL PRINCE ALFRED HOSPITAL Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 312652 0
Australia
Date submitted for ethics approval [1] 312652 0
28/06/2022
Approval date [1] 312652 0
23/08/2022
Ethics approval number [1] 312652 0
X22-0199 & 2022/ETH01250

Summary
Brief summary
Gum disease is a very common oral disease that, if not treated, may cause tooth loss. The disease is caused by bacteria that build deposits on your teeth, above and below your gums. These are known as dental plaque and these may mineralise forming dental calculus (or tartar) on tooth surfaces. Management of gum disease requires an adequate level of self-performed teeth cleaning as well as professional intervention aimed at removing dental plaque and calculus. Although this treatment is effective for most teeth, challenges arise in the management of teeth that have multiple roots, such as molars. When gum disease has progressed to involve these teeth they can be harder to maintain long term. Air polishing is a treatment modality approved by the Australian Federal Government (TGA approved) and currently used in dental treatment. AIR-FLOW®’ is a specialized device that generates a spray of air, water and powder to aid in plaque removal without additional patient discomfort. This study aims to focus on its use on maintaining molar teeth with gum disease.
The research has 3 main goals

1. Identify the impact of treatments on health/stability of gums around molar teeth.

2. Identifying the impact of treatments on the level of specific bacteria around molar teeth.

3. Determining how gum disease affects quality of life.

It is anticipated that the air polishing will assist in reducing the level of specific bacteria around molar teeth and provide additional improvement in the stability of gum health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125430 0
Dr Tihannad Divnic-Resnik
Address 125430 0
The University of Sydney Dental School, 2 Chalmers St, Surry Hills NSW 2010
Country 125430 0
Australia
Phone 125430 0
+61449855962
Fax 125430 0
Email 125430 0
tihana.divnic-resnik@sydney.edu.au
Contact person for public queries
Name 125431 0
Dr Tihannad Divnic-Resnik
Address 125431 0
The University of Sydney Dental School, 2 Chalmers St, Surry Hills NSW 2010
Country 125431 0
Australia
Phone 125431 0
+61449855962
Fax 125431 0
Email 125431 0
tihana.divnic-resnik@sydney.edu.au
Contact person for scientific queries
Name 125432 0
Dr Tihannad Divnic-Resnik
Address 125432 0
The University of Sydney Dental School, 2 Chalmers St, Surry Hills NSW 2010
Country 125432 0
Australia
Phone 125432 0
+61449855962
Fax 125432 0
Email 125432 0
tihana.divnic-resnik@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18648Ethical approval    385593-(Uploaded-21-03-2023-21-39-47)-Study-related document.pdf



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.