Clinical trial NCT02173236: The Effect of Platform Switching on Single Implants in the Esthetic Zone, Following Flapless Surgery and Early-Loading Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Impact of Platform-switching
Keywords: Dental Implant Platform Switching
Early Dental Implant Loading
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: plaque index
timeFrame: crown placement
measure: plaque index
timeFrame: post-loading 3 months
measure: plaque index
timeFrame: post-loading 6 months
measure: plaque index
timeFrame: post-loading 12 months
measure: gingival index
timeFrame: crown placement
measure: gingival index
timeFrame: post-loading 3 months
measure: gingival index
timeFrame: post-loading 6 months
measure: gingival index
timeFrame: post-loading 12 months
measure: Papillary index
timeFrame: crown placement
measure: Papillary index
timeFrame: post-loading 3 months
measure: Papillary index
timeFrame: post-loading 6 months
measure: Papillary index
timeFrame: post-loading 12 months
measure: The width of keratinized mucosa
timeFrame: crown placement
measure: The width of keratinized mucosa
timeFrame: post-loading 3 months
measure: The width of keratinized mucosa
timeFrame: post-loading 6 months
measure: The width of keratinized mucosa
timeFrame: post-loading 12 months
measure: Soft tissue level
timeFrame: crown placement
measure: Soft tissue level
timeFrame: post-loading 3 months
measure: Soft tissue level
timeFrame: post-loading 6 months
measure: Soft tissue level
timeFrame: post-loading 12 months
measure: Probing depth
timeFrame: crown placement
measure: Probing depth
timeFrame: post-loading 3 months
measure: Probing depth
timeFrame: post-loading 6 months
measure: Probing depth
timeFrame: post-loading 12 months
measure: marginal bone level changes
timeFrame: post-operative 2 weeks, immediately after crown delivery, 3, 6, and 12 months post-loading
measure: ridge height
timeFrame: prior to surgery
measure: ridge height
timeFrame: post-loading 12 months
measure: ridge width 3mm below crest
timeFrame: prior to surgery
measure: ridge width 3mm below crest
timeFrame: post-loading 12 months
measure: ridge width 10 mm below crest
timeFrame: prior to surgery
measure: ridge width 10 mm below crest
timeFrame: post-loading 12 months
measure: the presence of perforation or dehiscence
timeFrame: post-loading 1 year
Secondary outcomes:
measure: post-op experience
timeFrame: post-op 2weeks
measure: microbial analysis
timeFrame: 12 months after loading
measure: post-loading experience
timeFrame: post-op 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Graduate Periodontics, Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry
state: Michigan
Study officials:
References: