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Trial registered on ANZCTR


Registration number
ACTRN12617000531314
Ethics application status
Approved
Date submitted
13/03/2017
Date registered
11/04/2017
Date last updated
12/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical and microbiological evaluation of nonsurgical treatment of chronic periodontitis with systemically administered azithromycin
Scientific title
Clinical and microbiological evaluation of one-stage full mouth disinfection in conjunction with systemically administered azithromycin: a Randomised Controlled Clinical Trial in patients with moderate to advanced chronic periodontitis
Secondary ID [1] 291437 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic Periodontitis 302461 0
Condition category
Condition code
Oral and Gastrointestinal 302022 302022 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
Dentist will be delivering the treatment (nonsurgical instrumention of teeth) which is the conventional form o therapy for chronic periodontitis
study will be conducted in 7 sessions, ( treatment will be in 2 sessions) over 6 months followup at the Oral health centre of WA
Arm 1: One Stage Full Mouth Disinfection protocol (Nonsurgical periodontal scaling and root planing+ use of mouthwash) + placebo x 3 days orally
Arm2; One Stage Full Mouth Disinfection protocol(Non Surgical periodontal scaling and root planing + use of mouthwashes ) +systemic antimicrobial (Azithromycin, 5oomg x 3 days orally)
Treatment session 1) Clinical charting ( microbiological , saliva sampling using paper points) completed by Specialist periodontist at least 5 years ( 90 min session )
2) Oral hygiene instructions and plaque score ( 30 minutes session ) completed by experienced hygienist ( 5years)
3) Treatment session ( 90 - 120 minute session ) nonsurgical debridement of upper and lower left side of the mouth , use of mouthwash during session and to be used daily( 2 times, morning and night) for following 2 weeks .
Antimicrobial is provided to for start of use following session & for following 3 days( 1 tablet a day for 3 days)
- compliance sheet will be provided to the patient to tick each use of mouthwash and medication..Compliance sheet needs to be returned in 2 weeks review., empty medication bottles and empty mouthwash containers to be returned as well

Session 4( 90 -120 minutes) - Nonsurgical debridement of the upper and lower right side of mouth .In chair use of mouthwash during session as well.

Session 3 and Session 4 will be completed by a periodontics registrar( General dentist with 5 years experience in training for specialization) they will be both scheduled within 24 hours, as in 2 consecutive days

Session 5( Review in 2 weeks post therapy) , return medication pack , compliance sheet , and questionnaires to be filled by patient ( 20 minutes by Periodontics registrar )

Session 6 ( 3 months post therapy ) (90 minutes)
Clinical charting and microbiological sampling of saliva using paper points( performed by same specialist who previously did the charting )

Mouth wash used is 0.2 % Chlorhexidine mouthwash which is commonly used in periodontal therapy. Its available for non prescription used and has very effective antimicrobial qualities , to be used rinsing twice/ day morning and night 30 ml for 1 minute
Intervention code [1] 297473 0
Treatment: Drugs
Comparator / control treatment
Arm1 : One Stage Full Mouth Disinfection protocol (Nonsurgical periodontal scaling and root planing+ use of mouthwash) + placebo x 3 days orally (microcellulose tablet)
Control group
Placebo

Outcomes
Primary outcome [1] 301451 0
Difference in clinical probing pocket depth (PPD) reduction ( clinical measurement of probing depth)
Timepoint [1] 301451 0
90 days post therapy
Secondary outcome [1] 332704 0
- Differences in clinical probing atachment level ( PAL)
Timepoint [1] 332704 0
90 days ( 3 months ) post therapy
Secondary outcome [2] 333688 0
Differences in BLeeding on probing
Timepoint [2] 333688 0
90 days post therapy
Secondary outcome [3] 333689 0
- Microbiological changes attributed to treatment ( Measured using saliva testing with paper points which will be sent to a lab for PCR quantitative analysis of specific bacterial pathogen counts)
Timepoint [3] 333689 0
90 days post therapy

Eligibility
Key inclusion criteria
1) Healthy patients (ASA I and II classification)
2) Presence of 12 scorable teeth (not including third molars and teeth with orthodontic appliances, bridges, crowns, or implants)
3) Diagnosis of chronic periodontitis with the presence of at least four teeth with a probing depth (PPD) 5 mm, periodontal attachment loss (AL) 3 mm, and radiographic evidence of bone loss
Minimum age
25 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled systemic illnesses (i.e. diabetes mellitus, cancer, human Immunodeficiency syndrome, bone metabolic diseases or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
- Pregnancy or lactation
- Confirmed or suspected intolerance to azithromycin, macrolides or Chlorhexidine mouthwash
- Regular use of antibiotics or anti-inflammatory drugs within 3 months preceding the start of the study
- Regular use (twice a day) of chlorhexdine mouthwash or regular use within 3 months before study entry
- Periodontal therapy including dental scaling and root planing procedures in the 12 months preceding the start of the study
- Antibiotic prophylaxis required for periodontal clinical examination

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 who was "off-site" or at central administration site.
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 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
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be carried out according to a pre-established analysis plan. The procedure will be performed by the principal investigator (postgraduate student) under the supervision of a biostatistician with expertise in dentistry and blinded to the group allocation. A comparison of the baseline PPD (probing depth) values between the two groups at baseline, and 3months after therapy will be presented as primary outcome

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/01/2017
Date of last participant enrolment
Anticipated
1/05/2017
Actual
1/11/2017
Date of last data collection
Anticipated
31/12/2017
Actual
1/02/2018
Sample size
Target
40
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 15576 0
6009 - Nedlands
Recruitment postcode(s) [2] 15577 0
6009 - Broadway Nedlands

Funding & Sponsors
Funding source category [1] 295905 0
University
Name [1] 295905 0
University of Western Australia
Country [1] 295905 0
Australia
Funding source category [2] 295944 0
Charities/Societies/Foundations
Name [2] 295944 0
Australian Periodontal Research foundation
Country [2] 295944 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 294778 0
Charities/Societies/Foundations
Name [1] 294778 0
Australian Periodontal Research foundation
Address [1] 294778 0
P.O. Box 558
Windsor
NSW 2756
Country [1] 294778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297186 0
HUMAN RESEARCH ETHICS APPROVAL : THE UNIVERSITY OF WESTERN AUSTRALIA
Ethics committee address [1] 297186 0
35 Stirling Hwy, Crawley WA 6009
Ethics committee country [1] 297186 0
Australia
Date submitted for ethics approval [1] 297186 0
20/05/2016
Approval date [1] 297186 0
03/08/2016
Ethics approval number [1] 297186 0
RA/4/1/8328

Summary
Brief summary
Test null hypothesis: there is no difference in pocket depth reduction, between one stage full mouth disinfection with and without the use of adjuvant systemic antimicrobial therapy (Azithromycin) against the alternative hypothesis of a difference.

AIM :The purpose of this study will be to evaluate the use of systemically administered azithromycin as an adjuvant to OSFD (one stage full mouth disinfection) in the treatment of chronic periodontitis through clinical and microbiological periodontal parameters at baseline, 90 post therapy.

SIGNIFICANCE OF THE RESEARCH - Although general consensus favours the use of systemic antibiotics in conjunction with conventional staged debridement therapy in treatment of advanced periodontal diseases, there are limited studies where systemic antimicrobials were used in conjunction with one stage full mouth disinfection. To the best of our knowledge, there are no studies that evaluated clinically or microbiologically the use of azithromycin as an adjuvant to the OSFMD. This trial could help provide evidence based guidelines for the use of azithromycin in conjunction with OSFMD in treatment of patients with chronic periodontitis.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1575 1575 0 0
/AnzctrAttachments/372552-Application Approval (1).pdf (Ethics approval)
Attachments [2] 1576 1576 0 0
/AnzctrAttachments/372552(v13-03-2017-13-37-57)-OSFMD Proposal Final copy.pdf (Protocol)
Attachments [3] 1577 1577 0 0
/AnzctrAttachments/372552-Participant Information form.docx (Participant information/consent)
Attachments [4] 1578 1578 0 0
/AnzctrAttachments/372552-PARTICIPANT CONSENT FORM.docx (Participant information/consent)

Contacts
Principal investigator
Name 73266 0
Dr Eman Elhassan
Address 73266 0
Oral Health centre of WA
17 Monash Avenue
Nedlands WA 6009
Country 73266 0
Australia
Phone 73266 0
+6189346 4400
Fax 73266 0
Email 73266 0
[email protected]
Contact person for public queries
Name 73267 0
Eman Elhassan
Address 73267 0
Oral Health centre of WA
17 Monash Avenue
Nedlands WA 6009
Country 73267 0
Australia
Phone 73267 0
+618 9346 4400
Fax 73267 0
Email 73267 0
[email protected]
Contact person for scientific queries
Name 73268 0
Alessandro Quaranta
Address 73268 0
OralHealth centre of WA
17 Monash Avenue
Nedlands WA 6009
Country 73268 0
Australia
Phone 73268 0
+61478595727
Fax 73268 0
+618 9346 4400
Email 73268 0
[email protected]

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

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