None listed
Conditions
Brief summary
This trial aims to explore the clinical outcomes of commonly used dental implant designs on the market. The tissue stability around dental implants is associated with aesthetic and biological success. Both designs have independent evidence suggesting the potential to increase tissue stability. Patients from the Griffith University Dental School requiring two implants fulfilling criteria will be offered inclusion in the study. The study will involve monitoring routine parameters during associated procedures and recalls; along with the addition of a one off non-invasive dental plaque sample. It is expected that both implant designs will show at least equal results to industry standards if not benefits. Although, there is limited data directly comparing these designs in the literature, this study aims to reduce that void.
Interventions
Patients requiring 2 simple dental implants.
At placement the implant collar design will be randomly allocated: "BioHorizons internal tapered" or "BioHorizons internal tapered plus". Both implants have a laser microgrooved collar, that is 12 and 8 µm grooves on the coronal ~1-2 mm of the implant body. The "internal tapered plus" has a platform switched design between the abutment and implant in addition to the laser microgrooves.
One of each will be placed in each patient.
The implants are th
Patients requiring 2 simple dental implants. At placement the implant collar design will be randomly allocated: "BioHorizons internal tapered" or "BioHorizons internal tapered plus". Both implants have a laser microgrooved collar, that is 12 and 8 µm grooves on the coronal ~1-2 mm of the implant body. The "internal tapered plus" has a platform switched design between the abutment and implant in addition to the laser microgrooves. One of each will be placed in each patient. The implants are then placed according to routine protocols by periodontics registrars, who are fully qualified general dentists, with a minimum of 1 years post-graduate training already completed. These implants are placed during the same procedure. These procedures being un-altered from routine implant placement should take the average required time of 1-2 hours. These procedures, and adherence to intervention fidelity will be overseen and confirmed by the head of the discipline in Periodontics and Implantology.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• requiring 2 dental implants • Non-grafted type IV (Hammerle 2012) bone, • Adequate band of keratinsed tissues (at least 2mm); if soft tissue grafting is required, a 2-month healing time will be waited before implant surgery • Opposing occlusion • Sufficient space for restoration (At least 7mm of inter-arch space) • Over 18 years of age
Exclusion criteria
• Untreated or poorly maintained periodontal disease and/ or general dental care that have not been completed • Poor Oral Hygiene (PI >20%) • Severe Para-functional habits • Systemic illnesses which may compromise periodontal healing • Regular prescription of medications which may alter outcomes • Pregnancy • Consumption of illegal substances • Inability to give consent
Outcome results
None listed