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Trial registered on ANZCTR


Registration number
ACTRN12612000893808
Ethics application status
Approved
Date submitted
16/08/2012
Date registered
22/08/2012
Date last updated
1/07/2019
Date data sharing statement initially provided
1/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Replacing missing lower back teeth with an implant-supported removable partial denture.
Scientific title
Management of Kennedy Class 1 mandibular situations with a removable partial denture retained by a resilient retainer system supported by short implants; Objective and Subjective Measures.
Secondary ID [1] 281042 0
NIL
Universal Trial Number (UTN)
1111-1133-5593
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partial tooth loss 287175 0
Rehabilitation of missing teeth 287176 0
Condition category
Condition code
Oral and Gastrointestinal 287508 287508 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
Two treatment options will be compared (the trial will be designed as a within-subject cross-over trial, hence each subject will experience both interventions):
a) use of a conventional removable partial denture. This will involve standard clinical practice in designing and constructing a removable partial denture. In general, it will involve approximately 4 clinical appointments, each lasting between 30-60 minutes each. The appointments will generally be about 1 week apart, depending on how quickly the dental laboratory can prepare and return the required denture work. The denture will be tooth retained. After a 3 month adaptation period, a range of simple clinical tests and questionnaires will be used to assess the denture performance (approximately 2 hour appointment).
b) use of a removable partial denture retained and supported by dental implants. This will involve the surgical placement of two short and narrow implants per patient, conducted under local anaesthetic. The surgical appointment will take approximately 2 hours. Following healing (minimum of 6 weeks), the removable partial denture will be modified to incorporate the resilient retainer system (approximately 2 hour appointment), hence the denture will be both tooth and implant retained (after a 3 month adaptation period, a range of simple clinical tests and questionnaires will be used to assess the denture performance (approximately 2 hour appointment).
.

There will be a minimal-to-no wash-out period between the two treatment options. The dentures will be modified such that the patient will experience the alternate treatment option.

The aim will be for one operator to conduct all treatments, hence minimising the potential for operator inconsistencies.
Intervention code [1] 285500 0
Treatment: Surgery
Intervention code [2] 285501 0
Treatment: Devices
Comparator / control treatment
The controls will be:
a) the base-line situation before intervention
b) the conventional removable partial denture
Control group
Active

Outcomes
Primary outcome [1] 287756 0
Masticatory performance will be assessed clinically and pre-clinically by using a fractional sieving method of chewed Optosil material.
Timepoint [1] 287756 0
To occur during the following time points: a) baseline (time 0) b) 3 months after completion of the first intervention c) 3 months after completion of the second intervention
Secondary outcome [1] 298782 0
Maximum occlusal bite force will be assessed clinically using force transducers and/or pressure sensitive film. Pressure sensitive films are available from some of the major film manufacturers (i.e. Fuij Corp.) and reading devices area available to assess the range of bite forces that can be generated.
Timepoint [1] 298782 0
To occur during the following time points: a) baseline (time 0) b) 3 months after completion of the first intervention c) 3 months after completion of the second intervention.
Secondary outcome [2] 298783 0
Patient satisfaction - oral health related quality of life. This will be assessed using a version of the Oral Health Impact Profile 14 survey (OHIP-14) which has been modified for use in denture wearers.
Timepoint [2] 298783 0
To occur during the following time points: a) baseline (time 0) b) 3 months after completion of the first intervention c) 3 months after completion of the second intervention.

Eligibility
Key inclusion criteria
Kennedy class 1 pattern of missing teeth in the lower jaw
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unhealthy patients not able to safely undergoe elective dental surgery, patients with active dental disease, history of bisphosphonate use, inadequate bone volume for implant placement, and allergies to potential test foods such as peanuts

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)
All subjects will experience both interventions. However, which of the two interventions the subjects experiences first will be randomly determined. The person assessing the patients for eligibility to be included in the trial will not know which of the two treatment options the patient will experience first. This decision will be made on a random basis.

An independant 'holder' willhold a list outlining which treatment option each subject will experience first (see method below).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Use of a randimisation table from a suitable statistics book. Apart from this, no further concealment will be employed.

A list containing the numbers from 1 to 30 will be constructed. Next to each of these numbers, a 1 or 2 will be assigned (this will be determined randomly - using a statistics book). 1 will represent treatment option 1, and 2 will represent treatment option 2. This list will be given to an independant 'holder' who will keep this list under his/her control. As a participant is recruited into the trial, he/she will be sequentially given an identification number (a number from 1 - 30). The researcher will then contact the holder to establish which treatment option the newly recruited participant will receive first.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Aim will be for one operator to conduct all treatments, hence minimising the potential for operator inconsistencies
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2013
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
30/06/2017
Date of last data collection
Anticipated
Actual
18/06/2019
Sample size
Target
30
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285826 0
University
Name [1] 285826 0
University of Melbourne
Country [1] 285826 0
Australia
Primary sponsor type
University
Name
The University of Melbourne - Melbourne Dental School
Address
720 Swanston St, Carlton, VIC, 3053
Country
Australia
Secondary sponsor category [1] 284649 0
Individual
Name [1] 284649 0
George Alexopoulos
Address [1] 284649 0
720 Swanston St, Carlton, VIC, 3053
Country [1] 284649 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287844 0
The University of Melbourne Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 287844 0
Ethics committee country [1] 287844 0
Australia
Date submitted for ethics approval [1] 287844 0
31/08/2012
Approval date [1] 287844 0
26/10/2012
Ethics approval number [1] 287844 0

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

Contacts
Principal investigator
Name 34584 0
Dr George Alexopoulos
Address 34584 0
The University of Melbourne
Melbourne Dental School
720 Swanston Street
Carlton VIC 3053
Country 34584 0
Australia
Phone 34584 0
+61 421584842
Fax 34584 0
Email 34584 0
[email protected]
Contact person for public queries
Name 17831 0
George Alexopoulos
Address 17831 0
720 Swanston St,
Carlton, VIC, 3053
Country 17831 0
Australia
Phone 17831 0
+61421584842
Fax 17831 0
Email 17831 0
[email protected]
Contact person for scientific queries
Name 8759 0
George Alexopoulos
Address 8759 0
720 Swanston St,
Carlton, VIC, 3053
Country 8759 0
Australia
Phone 8759 0
+61421584842
Fax 8759 0
Email 8759 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
The data obtained throughout the trial will be statistically analysed and reported on as part of a research thesis. Most of the available data derived from the subjects will be aggregated (i.e. averaged). Until the statistical analysis is complete and the key outcomes determined, it is difficult to say what data (if any) from individual participants will need to be made available. Individual data (de-identified) will be included in the appendices of the thesis. This data will include: data tables for the various chewing and bite tests and answers to satisfaction/quality of life questionnaires. Any documents that cannot be de-identified will not be included in the thesis; these documents will be securely stored at The University of Melbourne as required by the Human Ethics approval requirements.


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.