the Impact of Platform-switching
Conditions
Keywords
Dental Implant Platform Switching, Early Dental Implant Loading
Brief summary
The impact of platform switching with flapless surgery on early-loaded single-tooth implants on esthetic outcomes.
Detailed description
Evaluation of clinical, radiographic and microbial outcomes of single implants with platform switching, compared to those with conventional platform.
Interventions
OTHERplatform-switched implants
OTHERplatform-matched implant
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients should be at least 18 years old and not currently pregnant * Systemically healthy with no medical contraindications to implant surgery * Having intact opposite tooth to proposed implant sites * The edentulous ridge with minimal ridge deformities.
Exclusion criteria
* unstable medical status or conditions which may compromise wound healing * osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.) * uncontrolled dental or periodontal diseases * edentulous ridges with the presence of fibrous dysplasia, severe tissue undercut, residual root, as well as insufficient dimensions or volume
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the presence of perforation or dehiscence | post-loading 1 year | using CBCT scan |
| ridge height | prior to surgery | the distance from the highest point of alveolar crest to the base of the maxillary arch |
| ridge width 3mm below crest | prior to surgery | the distance between the most prominent point on labial and palatal surfaces at the level of 3mm below the crest |
| ridge width 10 mm below crest | prior to surgery | the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest |
| plaque index | crown placement | (Silness and Loe 1964). 0 represented the absence of plaque. 1 was the presence of plaque at gingival margin. 2 was the presence of visible plaque; whereas 3 was recorded if abundant plaque was observed |
| gingival index | crown placement | (Loe 1967) As for GI, normal gingival was scored as 0. 1 meant the presence of mild inflammation, slight change in color, slight edema and no BOP. Moderate inflammation was represented by 2, inclusive of the presence of gingival redness, edema, glazing and BOP. Severe inflammation with marked redness, edema, ulceration and spontaneous bleeding was scaled as 3 |
| Papillary index | crown placement | (Jemt 1997) 0 = the absence of papilla, 1= \<50% of the height of the gingival embrasure, 2= 50-99% of the height of the gingival embrasure, 3 = 100% of the proximal space, 4= overgrowth of the interproximal tissue |
| The width of keratinized mucosa | crown placement | measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth. |
| Soft tissue level | crown placement | the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth |
| Probing depth | crown placement | Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles |
| marginal bone level changes | post-operative 2 weeks, immediately after crown delivery, 3, 6, and 12 months post-loading | the vertical distance between alveolar crest to platform level (both mesial and distal) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| microbial analysis | 12 months after loading | peri-implant microbial profile |
| post-loading experience | post-op 12 months | comfort, function (chewing/speaking), esthetics, and overall satisfaction |
| post-op experience | post-op 2weeks | pain, bleeding, swelling and overall discomfort |
Countries
United States
Outcome results
None listed