None listed
Conditions
Brief summary
This study aims to test a new implant overdenture treatment design that is surgically less invasive and more affordable to elderly patients. It uses only a single wide implant in the middle of the lower jaw and a new attachment system that would hopefully require less maintenance. The pool of participants will be from the Oral Implantology Research Group, Sir John Walsh Research Institute, School of Dentistry, University of Otago, Dunedin, New Zealand. The hypothesis to be tested are: The first hypothesis is that there is no difference in the success rate between single wide diameter implants and standard diameter single implants supporting lower jaw overdentures for one year after early loading protocol at 6 weeks after surgical placement. The second hypothesis is that there is no difference in the prosthodontic maintenance in the first year of service of lower jaw overdentures supported by single wide diameter implants and that of lower jaw overdentures supported by single regular diameter implants
Interventions
The participants will be randomly allocated into 3 groups, 2 test groups (groups 1 and 2) and 1 control group (group 3). Test group 1 participants will each receive a single wide (8mm) diameter, roughened-surface, externally-hexed, screw-shaped implant (Max-8, Southern Implants, Irene, South Africa). This implant has been originally developed by its manufacturer for immediate placement in fresh extraction sockets of molar teeth. The novel attachment system that will be used with this type of i
The participants will be randomly allocated into 3 groups, 2 test groups (groups 1 and 2) and 1 control group (group 3). Test group 1 participants will each receive a single wide (8mm) diameter, roughened-surface, externally-hexed, screw-shaped implant (Max-8, Southern Implants, Irene, South Africa). This implant has been originally developed by its manufacturer for immediate placement in fresh extraction sockets of molar teeth. The novel attachment system that will be used with this type of implant is made-up of a custom-made large ball abutment (5.9 mm) with a corresponding large plastic cap. Test group 2 participants will each receive a single regular (4mm) diameter, roughened-surface, screw-shaped implant (Neoss International, Harrogate, UK). The attachment system that will be used with this type of implant is the Locator attachment system. The control group participants (group 3) will each receive a single regular (3.75mm) diameter roughened-surface, externally hexed, screw-shaped implant (Southern Implants, Irene, South Africa). The attachment system that will be used with this type of implant is the standard (2.25mm) ball abutment with gold matrix. Surgical implant placement procedures for all 3 groups will follow a standardized one stage surgical approach with healing abutment connected to implants at surgery. Each single implant will be placed at the midline of the edentulous mandible of each participant. All the surgical procedures for implant placement are one-off procedures. The loading protocol adopted in this trial is an early loading protocol at 6 weeks and described as follows: After 6 weeks of healing after implant surgery, the healing abutments (for all groups) will be removed and the final abutments (corresponding the type of implant used in each group) will be fitted. A closed-mouth reline impression will be used to incorporate the corresponding matrix of each attachment into the mandibular denture of each participants thus converting into an implant overdenture.
Sponsors
Southern Implants
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Elderly edentulous patients with history of difficulties with their complete mandibular dentures and with minimum height and width of bone at the midline of the mandible to accommodate a 7X8 mm diameter implants
Exclusion criteria
Exclusion criteria: Any systemic or local condition contradictory to implant surgery; Bruxism, Irradiated or grafted jaws; Smoking > 10 cigarettes a day; Drug abuse; Un-willingness to attend regular recalls.
Outcome results
None listed