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Trial registered on ANZCTR


Registration number
ACTRN12619000259145
Ethics application status
Approved
Date submitted
15/02/2019
Date registered
20/02/2019
Date last updated
20/02/2019
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of the effect of different dental implant collar designs on the oral tissue response.
Scientific title
Clinical, microbial, and radiographic evaluation of dental implants with laser microgrooved collars with and without a platform-switched design: a randomised controlled clinical trial
Secondary ID [1] 297422 0
Nil known
Universal Trial Number (UTN)
U1111-1228-6735
Trial acronym
LPSRCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-implant health 311597 0
Condition category
Condition code
Oral and Gastrointestinal 310226 310226 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
Patients requiring 2 simple dental implants.
At placement the implant collar design will be randomly allocated: "BioHorizons internal tapered" or "BioHorizons internal tapered plus". Both implants have a laser microgrooved collar, that is 12 and 8 µm grooves on the coronal ~1-2 mm of the implant body. The "internal tapered plus" has a platform switched design between the abutment and implant in addition to the laser microgrooves.
One of each will be placed in each patient.
The implants are then placed according to routine protocols by periodontics registrars, who are fully qualified general dentists, with a minimum of 1 years post-graduate training already completed. These implants are placed during the same procedure. These procedures being un-altered from routine implant placement should take the average required time of 1-2 hours. These procedures, and adherence to intervention fidelity will be overseen and confirmed by the head of the discipline in Periodontics and Implantology.
Intervention code [1] 313679 0
Treatment: Devices
Comparator / control treatment
Control is the "BioHorizons internal tapered" implant. This implant does not include the additional platform switching used on 'BioHorizons internal tapered plus'
Control group
Active

Outcomes
Primary outcome [1] 319107 0
Radiographic marginal bone level
Timepoint [1] 319107 0
12 months
Secondary outcome [1] 366995 0
Marginal clinical soft tissue level: which will be assessed via way of clinical measurements from a removable customised stent.
Timepoint [1] 366995 0
12 months
Secondary outcome [2] 366996 0
Peri-implant periodontal probing depth
Timepoint [2] 366996 0
12 months
Secondary outcome [3] 366997 0
peri-implant microflora. Samples of dental plaque around the implants will be taken with paper points and analysed via "Carpegen Perio Diagnostics"
Timepoint [3] 366997 0
6 months

Eligibility
Key inclusion criteria
• requiring 2 dental implants
• Non-grafted type IV (Hammerle 2012) bone,
• Adequate band of keratinsed tissues (at least 2mm); if soft tissue grafting is required, a 2-month healing time will be waited before implant surgery
• Opposing occlusion
• Sufficient space for restoration (At least 7mm of inter-arch space)
• Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Untreated or poorly maintained periodontal disease and/ or general dental care that have not been completed
• Poor Oral Hygiene (PI >20%)
• Severe Para-functional habits
• Systemic illnesses which may compromise periodontal healing
• Regular prescription of medications which may alter outcomes
• Pregnancy
• Consumption of illegal substances
• Inability to give consent

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cross mouth study: both control and test are being placed in each participant such as to eliminate chance of "inter-group differences"
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The statistical analysis will be carried out by a professional statistician. The statistical unit will be mean values and standard deviations based on implants. The data will be analyzed using the paired Student’s t-test with confidence at 95% and statistical significance set at p<0.05.

Recruitment
Recruitment status
Not yet 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)
QLD
Recruitment hospital [1] 13161 0
Griffith University Clinical Trials Unit - Southport
Recruitment postcode(s) [1] 25716 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 301993 0
Commercial sector/Industry
Name [1] 301993 0
BioHorizons USA
Address [1] 301993 0
Global Headquarters
2300 Riverchase Center
Birmingham, AL 35244
USA
Country [1] 301993 0
United States of America
Primary sponsor type
University
Name
Griffith University
Address
Griffith Health Centre (G40), Gold Coast campus, Cnr Parklands Drive and Olsen Avenue, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 301774 0
None
Name [1] 301774 0
Address [1] 301774 0
Country [1] 301774 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302668 0
Griffith University Human Research Ethics
Ethics committee address [1] 302668 0
Griffith Human Research Ethics
Gold Coast campus
Griffith University QLD 4222
Australia
For more information regarding human ethics at Griffith, call (07) 3735 2069 or email us
research-ethics@griffith.edu.au
Ethics committee country [1] 302668 0
Australia
Date submitted for ethics approval [1] 302668 0
04/09/2018
Approval date [1] 302668 0
15/10/2018
Ethics approval number [1] 302668 0
2018/777

Summary
Brief summary
This trial aims to explore the clinical outcomes of commonly used dental implant designs on the market. The tissue stability around dental implants is associated with aesthetic and biological success. Both designs have independent evidence suggesting the potential to increase tissue stability. Patients from the Griffith University Dental School requiring two implants fulfilling criteria will be offered inclusion in the study. The study will involve monitoring routine parameters during associated procedures and recalls; along with the addition of a one off non-invasive dental plaque sample. It is expected that both implant designs will show at least equal results to industry standards if not benefits. Although, there is limited data directly comparing these designs in the literature, this study aims to reduce that void.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91002 0
Prof Alessandro Quaranta
Address 91002 0
School of Dentistry and Oral Health
Gold Coast campus
Griffith University QLD 4222
Australia
Country 91002 0
Australia
Phone 91002 0
(+617) 567 80421
Fax 91002 0
Email 91002 0
a.quaranta@griffith.edu.au
Contact person for public queries
Name 91003 0
Prof Alessandro Quaranta
Address 91003 0
School of Dentistry and Oral Health
Gold Coast campus
Griffith University QLD 4222
Australia
Country 91003 0
Australia
Phone 91003 0
(+617) 567 80421
Fax 91003 0
Email 91003 0
a.quaranta@griffith.edu.au
Contact person for scientific queries
Name 91004 0
Prof Alessandro Quaranta
Address 91004 0
School of Dentistry and Oral Health
Gold Coast campus
Griffith University QLD 4222
Australia
Country 91004 0
Australia
Phone 91004 0
(+617) 567 80421
Fax 91004 0
Email 91004 0
a.quaranta@griffith.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
Privacy of medical records
What supporting documents are/will be available?
No other documents available
Summary results
No Results