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Trial registered on ANZCTR


Registration number
ACTRN12623000206628
Ethics application status
Approved
Date submitted
13/02/2023
Date registered
27/02/2023
Date last updated
27/02/2023
Date data sharing statement initially provided
27/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of increasing mucosal (gum) thickness around dental implants in reducing early bone loss, in patients with limited mucosal thickness
Scientific title
The effect of vertical soft tissue augmentation with volume-stable collagen matrix on marginal bone levels around bone-level implants in thin mucosal tissue phenotype
Secondary ID [1] 308532 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental implant early marginal bone loss 328383 0
Condition category
Condition code
Oral and Gastrointestinal 325412 325412 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
Participants with thin mucosa (thin mucosal phenotype) receiving dental implant therapy to replace missing molar or premolar teeth will be randomised to 1 of 2 groups. Group 2 will receive implant placement with the placement of a soft tissue substitute (Geistlich Fibro-Gide®) which is an addition to the standard of care with the aim to increase the mucosal thickness. The procedures will be performed by either specialist periodontists or dentists currently specialising in periodontics who will be under the supervision of specialist periodontists. This will occur within a public oral health centre and private practice. The placement of the soft tissue substitute is anticipated to be approximately 5 minutes with a similar appointment length to routine dental implant placement (approximately 90 minutes).

Implant restoration will occur ~10-14 weeks following implant placement which allows adequate time for integration of the implant. The implant will be restored following either a conventional impression or digital intra-oral scan of the implant (at the discretion of the treating clinician) to allow fabrication of a screw retained ceramic crown which will be inserted at a separate appointment following fabrication of the custom crown. These appointments are anticipated to be approximately 30-45 minutes in duration.

Participants will then be reviewed at ~6 months and ~12 months following placement of the implant restoration during routine follow-ups to assess changes in the bone level around these implants (appointment duration ~30 minutes). Radiographs and clinical notes from all appointments will be documented within the participants secure profile.
Intervention code [1] 324983 0
Treatment: Devices
Intervention code [2] 324984 0
Prevention
Comparator / control treatment
The control arm includes those participants randomised to Group 1 who will receive implant placement as usual (standard care), without the additional placement of a soft tissue substitute material to augment the thickness of the mucosa
Control group
Active

Outcomes
Primary outcome [1] 333271 0
Assess differences in radiographic marginal bone level changes up to 12 months following restoration of bone level implants between augmented and non-augmented sites, measured in millimetres comparing parallel x-rays (periapical radiographs)
Timepoint [1] 333271 0
Baseline- implant placement
10-14 weeks from baseline- implant restoration
37-41 weeks from baseline- ~6 months following restoration
63-67 weeks from baseline- ~12 months following restoration
Secondary outcome [1] 416421 0
Assess differences in volumetric soft tissue changes using intra-oral scans up to 12 months following restoration of bone level implants between augmented and non-augmented sites
Timepoint [1] 416421 0
Baseline- implant placement
10-14 weeks from baseline- implant restoration
37-41 weeks from baseline- ~6 months following restoration
63-67 weeks from baseline- ~12 months following restoration

Eligibility
Key inclusion criteria
Inclusion Criteria
• 18 years or older
• Missing molar or premolar tooth in the lower or upper jaw with enough space for dental implant placement
• Gums less than or equal to 2mm thick at the potential implant site
• Sufficient volume of bone for implant placement without the need for bone grafting
• Placement of the implant at least 3 months after removal of the tooth (Type III-IV implant placement)
• Medically and periodontally (absence of uncontrolled gum disease) healthy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• Poor oral hygiene (Plaque Index >30%)
• Untreated or poorly maintained gum disease (periodontitis)
• Systemic illness or medications which may compromise healing (e.g. uncontrolled diabetes)
• Current smokers (more than 10 cigarettes daily)
• Pregnancy and breast-feeding females
• Inability to give informed consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed in opaque envelopes which will only be opened following placement of the dental implant
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 34 participants has been calculated allowing for a 10% drop out rate using G power analysis with an effect size of 0.7 based on previous clinical studies, a error= 0.05 and power= 95% . The statistical analysis will be carried out using 2-way analysis of variance (ANOVA) with confidence at 95% and statistical significance set at p<0.05. The statistical unit will be mean values and standard deviations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 39088 0
4006 - Herston
Recruitment postcode(s) [2] 39089 0
4000 - Brisbane
Recruitment postcode(s) [3] 39090 0
4122 - Mount Gravatt

Funding & Sponsors
Funding source category [1] 312777 0
University
Name [1] 312777 0
The University of Queensland
Country [1] 312777 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia Campus, St Lucia 4072 QLD
Country
Australia
Secondary sponsor category [1] 314409 0
None
Name [1] 314409 0
Address [1] 314409 0
Country [1] 314409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312070 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 312070 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 312070 0
Australia
Date submitted for ethics approval [1] 312070 0
15/08/2022
Approval date [1] 312070 0
16/11/2022
Ethics approval number [1] 312070 0
HREC/2022/QMS/86844

Summary
Brief summary
The primary purpose of this research is to evaluate potential benefits of thickening the soft tissue (gums) that surround dental implants, by placing a soft tissue substitute at the time of implant placement. The application of the soft tissue substitute may minimise the amount of bone loss that occurs following implant placement in the presence of thin soft tissue/gums (known as thin mucosal phenotype). Thin mucosal phenotype is observed when the thickness of the soft tissue (gums) at the planned implant site is 2mm or less. It has been demonstrated that a minimum thickness of the gums is required around dental implants, if this is not present loss of bone may occur around the shoulder/collar of the implant (the part of the implant closest to the surface), This occurs to accommodate an increase in thickness of the gums.

This study is evaluating the differences in marginal bone level changes which occur in the first 12 months after the implant is restored (a crown is placed on the implant), in sites which receive a soft tissue substitute at the time of implant placement (group 2), compared to sites which receive implant placement alone (group 1- this is the usual treatment approach). Study participants will be randomised to one of these treatment groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123358 0
A/Prof Ryan Lee
Address 123358 0
University of Queensland- School of Dentistry
288 Herston Rd, Herston QLD 4006
Country 123358 0
Australia
Phone 123358 0
+61 7 336 58013
Fax 123358 0
Email 123358 0
[email protected]
Contact person for public queries
Name 123359 0
Daniel McKenzie
Address 123359 0
University of Queensland- School of Dentistry
288 Herston Road, Herston QLD 4006
Country 123359 0
Australia
Phone 123359 0
+61 7 3365 8019
Fax 123359 0
Email 123359 0
[email protected]
Contact person for scientific queries
Name 123360 0
Daniel McKenzie
Address 123360 0
University of Queensland- School of Dentistry
288 Herston Road, Herston QLD 4006
Country 123360 0
Australia
Phone 123360 0
+61 7 3365 8019
Fax 123360 0
Email 123360 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
Raw data will not be published, only data for primary and secondary outcomes of the study will be published


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.