the Impact of Platform-switchingNCT02173236
The Effect of Platform Switching on Single Implants in the Esthetic Zone, Following Flapless Surgery and Early-Loading Protocols
A study testing platform-switched implants and platform-matched implant in people with the Impact of Platform-switching, run by University of Michigan at 1 site in United States.
Trial summary
The impact of platform switching with flapless surgery on early-loaded single-tooth implants on esthetic outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- the Impact of Platform-switching
- What is being tested?
- platform-switched implants and platform-matched implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics, Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109-1078
About this study
The impact of platform switching with flapless surgery on early-loaded single-tooth implants on esthetic outcomes.
Read the detailed description
Evaluation of clinical, radiographic and microbial outcomes of single implants with platform switching, compared to those with conventional platform.
- Conditions
- the Impact of Platform-switching
- Being tested
- platform-switched implants, platform-matched implant
- Keywords
- Dental Implant Platform Switching, Early Dental Implant Loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platform-switched implantsOther
Also called SuperLine™, Dentium Inc., Cypress, CA
platform-matched implantOther
Also called Zimmer TSV™, Zimmer Dental Inc., Carlsbad, CA
| Study group | Role | What they receive |
|---|---|---|
| platform-switched implants | Experimental | platform-switched implants vs. platform-matched implants Receives: Other: platform-matched implant |
| platform-matched implants | Active comparator | platform-switched implants vs. platform-matched implants Receives: Other: platform-switched implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque index
(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
Measured: crown placement
plaque index
(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
Measured: post-loading 3 months
plaque index
(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
Measured: post-loading 6 months
plaque index
(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
Measured: post-loading 12 months
gingival index
(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
Measured: crown placement
gingival index
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
Measured: post-loading 3 months
gingival index
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
Measured: post-loading 6 months
gingival index
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
Measured: post-loading 12 months
Papillary index
(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
Measured: crown placement
Papillary index
(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
Measured: post-loading 3 months
Papillary index
(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
Measured: post-loading 6 months
Papillary index
(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
Measured: post-loading 12 months
The width of keratinized mucosa
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
Measured: crown placement
The width of keratinized mucosa
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
Measured: post-loading 3 months
The width of keratinized mucosa
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
Measured: post-loading 6 months
The width of keratinized mucosa
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
Measured: post-loading 12 months
Soft tissue level
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Measured: crown placement
Soft tissue level
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Measured: post-loading 3 months
Soft tissue level
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Measured: post-loading 6 months
Soft tissue level
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Measured: post-loading 12 months
Probing depth
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Measured: crown placement
Probing depth
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Measured: post-loading 3 months
Probing depth
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Measured: post-loading 6 months
Probing depth
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Measured: post-loading 12 months
marginal bone level changes
the vertical distance between alveolar crest to platform level (both mesial and distal)
Measured: post-operative 2 weeks, immediately after crown delivery, 3, 6, and 12 months post-loading
ridge height
the distance from the highest point of alveolar crest to the base of the maxillary arch
Measured: prior to surgery
ridge height
the distance from the highest point of alveolar crest to the base of the maxillary arch
Measured: post-loading 12 months
ridge width 3mm below crest
the distance between the most prominent point on labial and palatal surfaces at the level of 3mm below the crest
Measured: prior to surgery
ridge width 3mm below crest
the distance between the most prominent point on labial and palatal surfaces at the level of 3mm below the crest
Measured: post-loading 12 months
ridge width 10 mm below crest
the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest
Measured: prior to surgery
ridge width 10 mm below crest
the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest
Measured: post-loading 12 months
the presence of perforation or dehiscence
using CBCT scan
Measured: post-loading 1 year
Secondary outcomes (3)
post-op experience
pain, bleeding, swelling and overall discomfort
Measured: post-op 2weeks
microbial analysis
peri-implant microbial profile
Measured: 12 months after loading
post-loading experience
comfort, function (chewing/speaking), esthetics, and overall satisfaction
Measured: post-op 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Impact of Platform-switchingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Ting Hsu, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173236
- Sponsor's protocol ID
- UM-
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platform Switching on Single Implants in the Esthetic Zone, Following Flapless Surgery and Early-Loading Protocols
- ClinicalTrials.gov ID
- NCT02173236
- Acronym / sponsor ID
- UM-
- Conditions
- the Impact of Platform-switching
- Keywords
- Dental Implant Platform Switching, Early Dental Implant Loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platform-switched implants | Experimental | Other: platform-matched implantplatform-switched implants vs. platform-matched implants |
| platform-matched implants | Active comparator | Other: platform-switched implantsplatform-switched implants vs. platform-matched implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platform-switched implantsAlso: SuperLine™, Dentium Inc., Cypress, CA | Other | platform-matched implants |
| platform-matched implantAlso: Zimmer TSV™, Zimmer Dental Inc., Carlsbad, CA | Other | platform-switched implants |
Primary outcome
plaque index
Time frame: 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
plaque index
Time frame: post-loading 3 months
(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
plaque index
Time frame: post-loading 6 months
(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
plaque index
Time frame: post-loading 12 months
(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
Time frame: 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
gingival index
Time frame: post-loading 3 months
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
gingival index
Time frame: post-loading 6 months
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
gingival index
Time frame: post-loading 12 months
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
Time frame: 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
Papillary index
Time frame: post-loading 3 months
(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
Papillary index
Time frame: post-loading 6 months
(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
Papillary index
Time frame: post-loading 12 months
(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
Time frame: crown placement
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
The width of keratinized mucosa
Time frame: post-loading 3 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
The width of keratinized mucosa
Time frame: post-loading 6 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
The width of keratinized mucosa
Time frame: post-loading 12 months
measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
Soft tissue level
Time frame: crown placement
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Soft tissue level
Time frame: post-loading 3 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Soft tissue level
Time frame: post-loading 6 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Soft tissue level
Time frame: post-loading 12 months
the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth
Probing depth
Time frame: crown placement
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Probing depth
Time frame: post-loading 3 months
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Probing depth
Time frame: post-loading 6 months
Probing depth (PD) on the implant has also been recorded at 6 points mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual line-angles
Probing depth
Time frame: post-loading 12 months
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
Time frame: 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)
ridge height
Time frame: prior to surgery
the distance from the highest point of alveolar crest to the base of the maxillary arch
ridge height
Time frame: post-loading 12 months
the distance from the highest point of alveolar crest to the base of the maxillary arch
ridge width 3mm below crest
Time frame: 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 3mm below crest
Time frame: post-loading 12 months
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
Time frame: prior to surgery
the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest
ridge width 10 mm below crest
Time frame: post-loading 12 months
the distance between the most prominent point on labial and palatal surfaces at the level of 10 mm below the crest
the presence of perforation or dehiscence
Time frame: post-loading 1 year
using CBCT scan
3 secondary outcomes
post-op experience
Time frame: post-op 2weeks
microbial analysis
Time frame: 12 months after loading
post-loading experience
Time frame: post-op 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platform-switched implants and platform-matched implant in people with the Impact of Platform-switching, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plaque index (time frame: crown placement). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.