Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000989448p
Ethics application status
Submitted, not yet approved
Date submitted
6/08/2025
Date registered
8/09/2025
Date last updated
8/09/2025
Date data sharing statement initially provided
8/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing effectiveness of rough and smooth dental implants on jaw function after jaw reconstruction for cancer.
Scientific title
A randomised controlled trial comparing effectiveness of rough and smooth dental implants on jaw function after jaw reconstruction for cancer patients.
Secondary ID [1] 315073 0
None
Universal Trial Number (UTN)
Trial acronym
MSC Dental Implant Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 338458 0
Jaw Reconstruction 338459 0
Dental Implants 338460 0
Condition category
Condition code
Cancer 334756 334756 0 0
Head and neck
Oral and Gastrointestinal 334757 334757 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 334758 334758 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary objective is to compare bone loss around a standard dental implant (IBNT) (control) and a smooth-cuffed dental implant (MSC-IBNT) (intervention) placed in patients undergoing jaw reconstruction using osseous free flaps. Both implants are used in routine clinical dentistry, however, this study will focus on patients undergoing reconstruction of the oral cavity for cancer where it is unknown which type of implant is associated with longer implant survival

The Intervention: MSC-IBNT are dental implants that have a smooth cuff just below the collar near the emergence of the implant from the bone. MSC-IBNT refers to a specific dental implant system that features the Machined Surface Coronal (MSC) hybrid design and incorporates "Innovative Narrow Body Tapered" (IBNT) features. This design combines a smooth coronal surface to resist bacterial adhesion and a moderately rough surface for superior osseointegration.

How the MSC-IBNT is applied: The implant site (osteotomy) will be prepared in the fibula following a standardised protocol. The IBNT and MSC-IBNT implants will be placed in the same manner but alternating. Note: This intervention does not differ from the standard of care.
1. Point drill
2. 2.2 mL Tru Guide drill to 2mm beyond desired implant length (stop short of being beyond inferior cortex)
3. Using drill extension, use 2.9mm parallel drill to previous osteotomy length
4. Using IBNT tap to desired implant length
5. Use 3mm round bur to reduce bone to facilitate full seating of the implant and space for components to be secured to the implant without bony interferences.
6. Implant placement and aim for insertion torque of 40 Ncm
7. Check for the need for further crestal bone reduction if required

The surgeon will complete an IMPLANT PLACEMENT PROFORMA to record compliance with the protocol.

Approximate duration of the surgery: The Head and Neck reconstruction surgery with dental implants can take between 6-10 hours (standard of care)

Interventions include:
Participants will receive both types of dental implants (if requiring more than one dental implant). The dental implants will be randomly chosen for implant location in your mouth and type at each location.

Preoperative appointment with your surgeon for reconstructive surgery, participants will answer a quality-of-life questionnaire, which will take approximately 10 – 15 minutes. The head and neck reconstructive surgery is planned and dental implants will be placed.

Following your surgery, bone loss and soft tissue assessments will be conducted every 3 months for 1 year after your operation as routine standard of care. However, these appointments are longer to assess bone loss (15 to 30 minutes) and soft tissue health (15 to 30 minutes) around dental implants for trial purpose. Participants will also complete a quality-of-life questionnaire (10 – 15 minutes) at each of the follow up appointments.
Intervention code [1] 331684 0
Treatment: Surgery
Intervention code [2] 331685 0
Treatment: Other
Comparator / control treatment
Standard care as control: Dental implants (IBNT) with a rough surface from top to bottom of the implant.
Control group
Active

Outcomes
Primary outcome [1] 342401 0
Compare bone loss around rough (IBNT) and smooth (MSC-IBNT) dental implants placed.
Timepoint [1] 342401 0
3months, 6months, 9months, 12months (primary) post-op
Primary outcome [2] 342402 0
To compare soft tissue health around IBNT and MSC-IBNT dental implants placed in patients undergoing jaw reconstruction using osseous free flaps
Timepoint [2] 342402 0
3months, 6months, 9months, 12months (primary) post-op
Secondary outcome [1] 450696 0
To assess quality of life outcomes associated with bone and soft tissue health around dental implants in patients undergoing jaw reconstruction using osseous free flaps
Timepoint [1] 450696 0
Pre-op; 3months, 6months, 9months, 12months post-op
Secondary outcome [2] 451824 0
To assess quality of life outcomes associated with bone and soft tissue health around dental implants in patients undergoing jaw reconstruction using osseous free flaps
Timepoint [2] 451824 0
Pre-op; 3months, 6months, 9months, 12months post-op

Eligibility
Key inclusion criteria
All cases will be discussed at MDT and deemed appropriate for the protocol within that setting. Osseous free flap reconstruction of the jaw requiring dental rehabilitation with endosteal dental implants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent
< 18 years of age.

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)

Randomisation will be based on the first implant in alphabetical sequence from right to left in the maxilla and then the mandible. The randomisation for the choice of the first dental implant (IBNT or MSC-IBNT) will be generated following participant’s enrolment after the signing of the consent form by the study team and the dental implant plan has been completed by the threating surgeons. A randomisation list will be created by an independent biostatistician and that the investigators enrolling patients will not have access to this list. A statistician will draw up a randomisation schedule and place it into the REDCap project for the study team to conduct randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 208 dental implants per group, or 416 dental implants in total. The mean number of dental implants is 4 per patient, thus the participant sample size is 104 patients.

The primary endpoint is bone loss at 12 months.
The sample size is based on a historical rate of bone loss around dental implants of 20%, with a clinically meaningful difference of 10%, with 80% power, and two-sided significance of 5%.

Descriptive statistics will be used for the primary outcomes. Associations will be assessed using chi square tests for categorical variables and t-tests for normally distributed continuous data. Generalised estimating equations will be used for longitudinal data, such as quality of life outcomes

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2028
Actual
Date of last data collection
Anticipated
30/09/2029
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28294 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 44506 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 319641 0
Hospital
Name [1] 319641 0
Chris O'Brien Lifehouse
Country [1] 319641 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 322147 0
None
Name [1] 322147 0
Address [1] 322147 0
Country [1] 322147 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318207 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 318207 0
Ethics committee country [1] 318207 0
Australia
Date submitted for ethics approval [1] 318207 0
06/08/2025
Approval date [1] 318207 0
Ethics approval number [1] 318207 0

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

Contacts
Principal investigator
Name 143438 0
Prof Jonathan Clark
Address 143438 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 143438 0
Australia
Phone 143438 0
+61 02 8514 0268
Fax 143438 0
Email 143438 0
[email protected]
Contact person for public queries
Name 143439 0
Masako Dunn
Address 143439 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 143439 0
Australia
Phone 143439 0
+61 02 8514 0411
Fax 143439 0
Email 143439 0
[email protected]
Contact person for scientific queries
Name 143440 0
Jonathan Clark
Address 143440 0
Chris O'Brien Lifehouse; 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 143440 0
Australia
Phone 143440 0
+61 02 8514 0268
Fax 143440 0
Email 143440 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.