Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001016224
Ethics application status
Approved
Date submitted
22/05/2018
Date registered
18/06/2018
Date last updated
12/07/2023
Date data sharing statement initially provided
12/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Narrow diameter dental implant for replacing single missing back tooth
Scientific title
Titanium-zirconium narrow (3.3 mm) versus standard (4.1 mm) diameter dental implants for replacing single posterior missing teeth: a randomized controlled trial
Secondary ID [1] 294960 0
None
Universal Trial Number (UTN)
U1111-1211-4551
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Missing posterior tooth 308208 0
Condition category
Condition code
Oral and Gastrointestinal 306993 306993 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
Placement of 17 narrow-3.3 mm diameter TiZr single implants to replace single missing posterior tooth by periodontist. It is expected that contour augmentation is not required.
Intervention code [1] 301287 0
Treatment: Devices
Comparator / control treatment
Placement of standard-4.1 mm diameter TiZr single implants placed with simultaneous contour augmentation to replace single missing posterior tooth by periodontist.
Control group
Active

Outcomes
Primary outcome [1] 305980 0
Implant success rate (assessed according to success criteria). The implant success criteria included of absence of clinical mobility. abscence of pain, neuropathy or periimplant radiolucency and a maximal bone loss of 1.5 mm during the first year of function and < 0.2 mm annually.
This information will collected by clinical and radiographic examination.

Timepoint [1] 305980 0
At one, two, three years post implant placement.
Primary outcome [2] 305981 0
Patient satisfaction (evaluated using visual analogue scale and oral health related quality of life tool).
Timepoint [2] 305981 0
Primary time point: at time of implant placement.
Follow-up appointments:
one year after implant placement.
two years after implant placement.
three years after implant placement.
Primary outcome [3] 305982 0
Need for additional bone augmentation (assessed as whether bone augmentation has been used or not by direct observation by the operator)
Timepoint [3] 305982 0
At the time of implant placement.
Secondary outcome [1] 347187 0
Operating time (assessed from the time of preparing the site from implant placement until the site is sutured). The time will be assessed in minutes by direct observation of the assisting staff.
Timepoint [1] 347187 0
At the time of implant placement.
Secondary outcome [2] 347188 0
Changes in peri-implant marginal bone level (using peri-apical radiographs).
Timepoint [2] 347188 0
Primary time point: At the time of implant crown placement.
Follow-up appointments:
One year after the placement of implant crown.
Two years after the placement of implant crown.
Three years after placement of implant crown.
Secondary outcome [3] 347190 0
Implant stability measurements (using resonance frequency analysis).
Timepoint [3] 347190 0
At the time of implant placement
Secondary outcome [4] 347192 0
Soft tissue levels changes (using photos).
Timepoint [4] 347192 0
Primary time point: At the time of implant crown placement.
Follow-up appointments:
One year after the placement of implant crown.
Two years after the placement of implant crown.
Three years after placement of implant crown.
Secondary outcome [5] 347194 0
Aesthetic outcomes (as assessed by using pink aesthetic score (PES) and white aesthetic score (WES)
Timepoint [5] 347194 0
At the time of implant crown replacement
Secondary outcome [6] 347196 0
Biological complications (by radiographs and measuring bleeding on probing and deep probing depths).
Timepoint [6] 347196 0
At the time of implant crown placement
Secondary outcome [7] 347197 0
Mechanical complications (reporting events such as crown chipping or screw loosening).
Timepoint [7] 347197 0
At the time of implant crown placement
Secondary outcome [8] 347198 0
Functional Implant Prosthodontic Score (using clinical and radiographic parameters to assess single unit implant crowns).
Timepoint [8] 347198 0
At the time of implant crown placement

Eligibility
Key inclusion criteria
• Require replacement of posterior single missing tooth.
• Limited bone availability in the horizontal dimension.
• Aged 18 or over.
• Controlled oral hygiene (full-mouth plaque and bleeding scores less than 25% at baseline).
• Good compliance and commitment to attend follow-up review appointments.
• Willing to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Localised / generalised chronic or aggressive periodontitis.
• Severe bruxism or parafunctional habits.
• Large occlusal discrepancies.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
3/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 10494 0
New Zealand
State/province [1] 10494 0
Otago
Country [2] 25642 0
United Arab Emirates
State/province [2] 25642 0
Dubai

Funding & Sponsors
Funding source category [1] 299547 0
Other
Name [1] 299547 0
ITI International Team for Implantology
Country [1] 299547 0
Switzerland
Primary sponsor type
University
Name
Faculty of Dentistry / University of Otago
Address
310 Great King Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 298862 0
University
Name [1] 298862 0
Research and Enterprise, University of Otago
Address [1] 298862 0
University of Otago
290 Great King Street
Dunedin 9016
Country [1] 298862 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300445 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 300445 0
Ethics committee country [1] 300445 0
New Zealand
Date submitted for ethics approval [1] 300445 0
03/04/2018
Approval date [1] 300445 0
21/05/2018
Ethics approval number [1] 300445 0
18/NTA/53

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83690 0
Dr Momen Atieh
Address 83690 0
Dr Momen Atieh
University of Otago
Faculty of Dentistry
310 Great King Street
Dunedin 9016
Country 83690 0
New Zealand
Phone 83690 0
+61 3 479 7062
Fax 83690 0
Email 83690 0
[email protected]
Contact person for public queries
Name 83691 0
Momen Atieh
Address 83691 0
Dr Momen Atieh
University of Otago
Faculty of Dentistry
310 Great King Street
Dunedin 9016
Country 83691 0
New Zealand
Phone 83691 0
+61 3 479 7062
Fax 83691 0
Email 83691 0
[email protected]
Contact person for scientific queries
Name 83692 0
Momen Atieh
Address 83692 0
Dr Momen Atieh
University of Otago
Faculty of Dentistry
310 Great King Street
Dunedin 9016
Country 83692 0
New Zealand
Phone 83692 0
+61 3 479 7062
Fax 83692 0
Email 83692 0
[email protected]

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?

No Supporting Document Provided



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.