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

Study Overview
=================
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.

Conditions
-----------------
the Impact of Platform-switching

Intervention / Treatment
-----------------
* Other: platform-switched implants
* Other: platform-matched implant


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platform-switched implants<br>platform-switched implants vs. platform-matched implants | Other: platform-matched implant<br> <br> * Other names: Zimmer TSV™, Zimmer Dental Inc., Carlsbad, CA;|
| Active Comparator: platform-matched implants<br>platform-switched implants vs. platform-matched implants | Other: platform-switched implants<br> <br> * 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Implant Platform Switching, Early Dental Implant Loading