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OpenTrials
Completed

NCT Number: NCT02173236

The Effect of Platform Switching on Single Implants in the Esthetic Zone, Following Flapless Surgery and Early-Loading Protocols

The impact of platform switching with flapless surgery on early-loaded single-tooth implants on esthetic outcomes.

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Key information

Conditions

the Impact of Platform-switching

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Periodontics, Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109-1078, United States

About this study

Evaluation of clinical, radiographic and microbial outcomes of single implants with platform switching, compared to those with conventional platform.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platform-switched implants

Other

Other names: SuperLine™, Dentium Inc., Cypress, CA

platform-matched implant

Other

Other names: Zimmer TSV™, Zimmer Dental Inc., Carlsbad, CA

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. The width of keratinized mucosa

    Time frame: crown placement

    measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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)

  26. ridge height

    Time frame: prior to surgery

    the distance from the highest point of alveolar crest to the base of the maxillary arch

  27. ridge height

    Time frame: post-loading 12 months

    the distance from the highest point of alveolar crest to the base of the maxillary arch

  28. 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

  29. 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

  30. 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

  31. 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

  32. the presence of perforation or dehiscence

    Time frame: post-loading 1 year

    using CBCT scan

Secondary outcomes

  1. post-op experience

    Time frame: post-op 2weeks

    pain, bleeding, swelling and overall discomfort

  2. microbial analysis

    Time frame: 12 months after loading

    peri-implant microbial profile

  3. post-loading experience

    Time frame: post-op 12 months

    comfort, function (chewing/speaking), esthetics, and overall satisfaction

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.