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Trial registered on ANZCTR


Registration number
ACTRN12615001047583
Ethics application status
Approved
Date submitted
9/09/2015
Date registered
7/10/2015
Date last updated
25/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Adjunctive Systemic Azithromycin versus Amoxycillin and Metronidazole in Non-Surgical Mechanical Therapy of Periodontitis
Scientific title
Efficacy of adjunctive azithromycin versus amoxycillin and medtronidazole, and placebo in the treatment of chronic periodontitis in adults
Secondary ID [1] 287286 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Periodontitis 295922 0
Condition category
Condition code
Oral and Gastrointestinal 296180 296180 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 296181 296181 0 0
Other infectious diseases
Inflammatory and Immune System 296502 296502 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions:
Scaling & root planing with Azithromycin - 500mg, once a day, 4 days
Scaling & root planing with Amoxycillin (500mg) & Metronidazole (400mg) both 3 times a day for 8 days
Scaling & root planing with Placebo
A patient questionnaire will be given to check for compliance and record any adverse effects


Scaling and root planing
- removal of hard and soft deposits on the tooth and root surfaces that contribute to infection under local anaesthesia
- divided into 2 sessions (right hand side followed by left hand side of mouth) from 24 hours - 1 week apart

Drug administration
- oral tablet
- begins the morning of the first session of scaling and root planing
Intervention code [1] 292604 0
Treatment: Drugs
Intervention code [2] 292605 0
Treatment: Other
Comparator / control treatment
Scaling & root planing with Placebo microcellulose tablet, once a day, 5 days

Control group
Placebo

Outcomes
Primary outcome [1] 295849 0
Proportion of participants who show a reduction in probing pocket depths as measured by the investigator with an automated periodontal probe
Timepoint [1] 295849 0
At 3 months and 6 months after completion of second (final) appointment of scaling and root planing
Primary outcome [2] 295851 0
Proportion of participants who show a reduction in bacterial counts (Porphyromonas gingivalis, Tannerella forsythia, Aggregatibacter actinomycetemcomitans) as assessed by laboratory analysis of plaque samples
Timepoint [2] 295851 0
Immediately after, 9 days, 3 months, and 6 months after 2nd (final) appointment of scaling and root planing
Secondary outcome [1] 316720 0
Proportion of participants who show a reduction in bleeding on probing as assessed by the investigator using an automated periodontal probe and using a dichotomous scale at each site (present/not present)
Timepoint [1] 316720 0
At 3 months and 6 months after completion of 2nd (final) appointment of scaling and root planing
Secondary outcome [2] 316721 0
Proportion of participants who show a gain in clinical attachment level as measured by the investigator with an automated periodontal probe
Timepoint [2] 316721 0
At 3 months and 6 months after completion of 2nd (final) appointment of scaling and root planing

Eligibility
Key inclusion criteria
1. Patients with moderate - severe chronic periodontitis
2. Approximal Plaque Index <40%
3. Sulcus Bleeding Index <30%
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with known allergies to test antimicrobial agents
2. Patients who have received periodontal therapy in the previous 3 months
3. Patients who have used systemic antibiotics within the previous 3 months
4. Patients who are pregnant or breastfeeding
5. Patients with systemic conditions that could influence the outcome of periodontal therapy
6. Patients that require antibiotic prophylaxis

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)
Enrolment:
Patients will be recruited from those referred to the Periodontics Department at Sydney Dental Hospital, Sydney, NSW. If a patient meets the inclusion and exclusion criteria, they will be given an opportunity to participate in the study. Appropriate information (including patient information brochure) will be given. If a patient chooses to participate, written consent will be gained. If a patient declines participation, it will have no negative impact on their treatment at the department.
Allocation:
A clinician, outside the project team, will be carrying out non-surgical mechanical periodontal therapy. They will be dispensing the antibiotics or placebos in numbered containers. The patient, the investigators, and the treating clinician will not know which patient was allocated to which group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence of allocation:
Simple coin-tossing by a person outside the project team
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 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Group sample sizes of 17 to achieve 80.704% power to reject the null hypothesis of equal means when the population mean difference is 1.0 with a standard deviation for both groups of 1.0 and with a significance level (alpha) of 0.050 using a two-sided two-sample equal-variancet-test.


Recruitment
Recruitment status
Active, not recruiting
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)
NSW
Recruitment hospital [1] 4219 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 10184 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 291868 0
University
Name [1] 291868 0
University of Sydney
Address [1] 291868 0
NSW 2006
Country [1] 291868 0
Australia
Primary sponsor type
Individual
Name
Meredith Owen
Address
Sydney Dental Hospital
Department of Periodontics
Level 4
2 Chalmers Street
Surry Hill, NSW
2010
Country
Australia
Secondary sponsor category [1] 290532 0
Individual
Name [1] 290532 0
Associate Professor Axel Spahr
Address [1] 290532 0
Sydney Dental Hospital
Department of Periodontics
Level 4
2 Chalmers Street
Surry Hill, NSW
2010
Country [1] 290532 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293377 0
Sydney Local Health District Ethics Review Committee (ERC)/ Clinical Trials Sub-Committee (CTS-C)
Ethics committee address [1] 293377 0
SLHD Ethics Review Committee (RPAH Zone)
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN, NSW
2050
Ethics committee country [1] 293377 0
Australia
Date submitted for ethics approval [1] 293377 0
28/10/2015
Approval date [1] 293377 0
26/07/2016
Ethics approval number [1] 293377 0

Summary
Brief summary
The aim of this study is to compare the clinical and microbial changes occurring in chronic periodontitis patients receiving non-surgical treatment alone or with systemically administered azithromycin or with amoxicyllin and metronidazole.

The hypothesis is that non-surgical periodontal treatment in combination with systemically administered azithromycin will have superior effects on treatment outcomes (clinical and microbial parameters) than non-surgical periodontal therapy alone or in combination with systemically adminstered amoxicillin and metronidazole.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59570 0
A/Prof Axel Spahr
Address 59570 0
Sydney Dental Hospital
Department of Periodontics
Level 4
2 Chalmers Street
Surry Hills, NSW
2010
Country 59570 0
Australia
Phone 59570 0
+61 2 9293 3274
Fax 59570 0
+61 2 9293 3335
Email 59570 0
axel.spahr@sswahs.nsw.gov.au
Contact person for public queries
Name 59571 0
Dr Meredith Owen
Address 59571 0
Sydney Dental Hospital
Department of Periodontics
Level 4
2 Chalmers Street
Surry Hills, NSW
2010
Country 59571 0
Australia
Phone 59571 0
+61 2 9293 3274
Fax 59571 0
+61 2 9293 3335
Email 59571 0
dr.meredith.owen@gmail.com
Contact person for scientific queries
Name 59572 0
Dr Meredith Owen
Address 59572 0
Sydney Dental Hospital
Department of Periodontics
Level 4
2 Chalmers Street
Surry Hills, NSW
2010
Country 59572 0
Australia
Phone 59572 0
+61 2 9293 3274
Fax 59572 0
+61 2 9293 3335
Email 59572 0
meredithowen@gmail.com

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