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

Not Applicable

Completed

• Conditions: the Impact of Platform-switching
• Interventions: Other: platform-matched implant; Other: platform-switched implants

• Registration Number: NCT02173236
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-06
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-23
• Last Update Submitted: 2014-06-23
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platform-switched implants	platform-matched implant	platform-switched implants vs. platform-matched implants
platform-matched implants	platform-switched implants	platform-switched implants vs. platform-matched implants

Primary Outcome Measures

Name	Time	Method
plaque index	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	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	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	post-loading 12 months	measured at the midpoint on mid-facial surfaces of implants and adjacent two teeth.
Soft tissue level	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	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	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	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	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	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	post-loading 1 year	using CBCT scan

Secondary Outcome Measures

Name	Time	Method
post-op experience	post-op 2weeks	pain, bleeding, swelling and overall discomfort
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

Trial Locations

Locations (1)

Graduate Periodontics, Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States