None listed
Conditions
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.
Interventions
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 b
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed