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.

Study Overview

• Status: Completed
• Conditions: the Impact of Platform-switching
• Intervention / Treatment: Other: platform-matched implant; Other: platform-switched implants

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1078
      • Graduate Periodontics, Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: platform-switched implants; platform-switched implants vs. platform-matched implants	Other: platform-matched implant; Other Names: Zimmer TSV™, Zimmer Dental Inc., Carlsbad, CA
Active Comparator: platform-matched implants; platform-switched implants vs. platform-matched implants	Other: platform-switched implants; Other Names: SuperLine™, Dentium Inc., Cypress, CA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	post-loading 12 months
The width of keratinized mucosa	measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.	crown placement
The width of keratinized mucosa	measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.	post-loading 3 months
The width of keratinized mucosa	measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.	post-loading 6 months
The width of keratinized mucosa	measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.	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	crown placement
Soft tissue level	the vertical distance from the gingival margin to the line connecting the facial gingival margin of two adjacent teeth	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	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	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	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	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	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	post-loading 12 months
marginal bone level changes	the vertical distance between alveolar crest to platform level (both mesial and distal)	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	prior to surgery
ridge height	the distance from the highest point of alveolar crest to the base of the maxillary arch	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	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	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	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	post-loading 12 months
the presence of perforation or dehiscence	using CBCT scan	post-loading 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-op experience	pain, bleeding, swelling and overall discomfort	post-op 2weeks
microbial analysis	peri-implant microbial profile	12 months after loading
post-loading experience	comfort, function (chewing/speaking), esthetics, and overall satisfaction	post-op 12 months

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Dental Implant Platform Switching; Early Dental Implant Loading
• Other Study ID Numbers: UM-