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Trial registered on ANZCTR


Registration number
ACTRN12606000089538
Ethics application status
Approved
Date submitted
8/02/2006
Date registered
2/03/2006
Date last updated
7/11/2018
Date data sharing statement initially provided
7/11/2018
Date results information initially provided
7/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of periimplant diseases in humans. Treatment of periimplant mucositis
Scientific title
A randomised placebo controlled study to evaluate the effects of chlorhexidine in the treatment of periimplant mucositis assessing the outcome variables probing depth reduction and reduction in bleeding on probing.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periimplant mucositis 1053 0
Condition category
Condition code
Oral and Gastrointestinal 1134 1134 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
Double blind, placebo controlled clinical trial for treatment of periimplant mucositis using mechanical plaque control in combination with Chlorhexidine gel. A pea-sized amount of Chlorhexidine gel (0.2% of 1mg) is applied with a soft toothbrush to the affected implant twice a day for 4 weeks.
Reevaluation at 1 & 3 months
Intervention code [1] 889 0
None
Comparator / control treatment
A pea-sized amount of placebo is applied with a soft toothbrush to the affected implant twice a day for 4 weeks.
Reevaluation at 1 & 3 months
Control group
Placebo

Outcomes
Primary outcome [1] 1519 0
Probing depth change
Timepoint [1] 1519 0
At 1 and 3 months.
Secondary outcome [1] 2748 0
Microflora and bleeding on probing.
Timepoint [1] 2748 0
At 1 & 3 months.

Eligibility
Key inclusion criteria
At least 1 dental implant with periimplant mucositis.
Minimum age
21 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled diabetes subjects requiring prophylactic antibiotics.

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)
Central registrar. Code broken once study is completed and data is locked
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random allocation with subjects allocated to equal size treatment groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects, therapists and outcome assesors will be blinded
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
WA

Funding & Sponsors
Funding source category [1] 1235 0
Other Collaborative groups
Name [1] 1235 0
International Team of Implantology
Address [1] 1235 0
NA
Country [1] 1235 0
Switzerland
Primary sponsor type
University
Name
The University of Western Australia, CRROH
Address
NA
Country
Australia
Secondary sponsor category [1] 1092 0
University
Name [1] 1092 0
University of Berne CH
Address [1] 1092 0
NA
Country [1] 1092 0
Switzerland
Secondary sponsor category [2] 1093 0
University
Name [2] 1093 0
University of Queensland
Address [2] 1093 0
NA
Country [2] 1093 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2564 0
Berne Switzerland
Ethics committee address [1] 2564 0
Ethics committee country [1] 2564 0
Switzerland
Date submitted for ethics approval [1] 2564 0
Approval date [1] 2564 0
Ethics approval number [1] 2564 0
SKF/CRF 16/05
Ethics committee name [2] 2565 0
The University of Western Australia
Ethics committee address [2] 2565 0
Ethics committee country [2] 2565 0
Australia
Date submitted for ethics approval [2] 2565 0
Approval date [2] 2565 0
Ethics approval number [2] 2565 0
RA/4/1/1374

Summary
Brief summary
The purpose of this study is to evaluate the treatment of periimplant infection (mucositis) with a follow up period of 3 months. Treatment will begin with professional mechanical cleaning around the implant in addition to home tooth-brushing twice daily for 4 weeks with antiseptic (chlorhexidine) gel or placebo gel. The placebo gel will be of the same appearance as the chlorhexidine gel. The gels will be in identical tubes with identical labelling except for individual subjects study numbers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35587 0
Address 35587 0
Country 35587 0
Phone 35587 0
Fax 35587 0
Email 35587 0
Contact person for public queries
Name 10078 0
Lisa Heitz-Mayfield
Address 10078 0
Center for Rural and Remote Oral Health
University of Western Australia
21 Rheola Street
West Perth WA 6005
Country 10078 0
Australia
Phone 10078 0
+61 8 93217581
Fax 10078 0
Email 10078 0
heitz.mayfield@iinet.net.au
Contact person for scientific queries
Name 1006 0
Lisa Heitz-Mayfield
Address 1006 0
Center for Rural and Remote Oral Health
University of Western Australia
21 Rheola Street
West Perth WA 6005
Country 1006 0
Australia
Phone 1006 0
+61 8 93217581
Fax 1006 0
Email 1006 0
heitz.mayfield@iinet.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary