Single Tooth Restoration in the Maxilla Using the Straumann® PURE® Ceramic Implant Monotype: One Year Follow up

Study Overview
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Brief Summary
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The main objective is to evaluate peri-implant hard and soft tissues's stability with the use of a ceramic implant (Implant Straumann®Pure Ceramic) during one year follow up.

Detailed Description
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Nowadays, the material of choice for the manufacture of dental implants is titanium. However, if we consider the aesthetics, the use of metallic implants can lead to complications, namely metal translucency through the peri-implant mucosa or the presence of soft tissue recessions causing metal exposure. As an alternative to the use of titanium, we have zirconium, that is highly biocompatible and whose use in implantology has demonstrated a predictable osseointegration. In addition, some studies suggest a different histology that could help maintaining the stability of the peri-implant mucosa and, therefore, an improvement in long-term aesthetic results. The reason for designing this study is that there is not too much data about this type of implants, that can be, really, an alternative to those we know. To achieve those objectives a single-arm clinical trial is designed, using marginal bone loss as a primary response variable. It is estimated with the calculation of the sample size, we would need 30 patients to get relevant data. An experienced surgeon (M.V) will perform implant surgery. Later, experienced and calibrated examiners (R.E and E.RG) will collect the following clinical parameters at baseline, and at 4, 8 and 12 months: gingival recession, papillary Jemt index, width and height of the keratinized gingiva, probing depth, plaque index and bleeding on probing. Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as unit of analysis the implant.

Official Title
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Replacement of Individual Teeth in the Esthetic Zone of Upper Jaw by Using a Monoblock Ceramic Implant: One Year Follow up

Conditions
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Ceramic Implant

Intervention / Treatment
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* Device: Straumann Pure Ceramic Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of the Master of Periodontology of the UPV/EHU Age > 18 years Patient with one single tooth gap in the anterior maxilla Plaque and bleeding index (FMPS < 20%). Treated periodontal conditions The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent Exclusion Criteria: General contraindications for dental and/or surgical treatment are present. The patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs). Untreated periodontal conditions Patients not willing to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Straumann Pure Ceramic Implant<br>Replacement of single tooth gaps with a Zirconia implant | Device: Straumann Pure Ceramic Implant<br>* The surgical technique begins with the lift of a vestibular mucoperiosteal flap respecting the papillae of the adjacent teeth. After the alveolar bone is exposed, the sequence of drilling and placement of the intra-bone fixation are carried out. In case of fenestrations or dehiscence, they are treated by xenograft and collagen-absorbable membrane. Once the implant is placed, a healing cap or provisional prosthesis is placed depending on the torque achieved. Finally, the flap is replaced and sutured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone level change (MBLC) | Distance between the mesial/distal marginal crests and the first implant thread. This is calibrated based on the known length (1,8 mm) of the machined neck. | Change from baseline until 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival recession (REC) | Distance in mm from incisal edge to gingival margin. | Change from baseline (when the crown is cemented) until 12 months. | 
| Jemt Papilla index score (JPIS) | This score ranges from 0 to 3. Index score 0 denotes no soft tissue in the area; index score 1 denotes soft tissue reaching less than half the distance between the reference line and the contact point; index score 2 denotes more soft tissue than indicated by index score 1 but not extending all the way to the contact point; and index score 3 denotes tissue filling the entire embrasure. | Change from baseline until 12 months. | 
| Surgical complications (SC) | Any complication, as bleeding, dehiscence, loss of suture, etc... that may appear will be collected. | Surgery and the next 7 days. | 
| Prosthetic complications (PC) | Any difficulty during the confection of the crown, complications as descementation, chipping, etc... will be registered. | Baseline, 4, 8 and 12 months. | 
| Probing depth (PD) | Distance in mm from the gingival margin to the bottom of peri-implant pocket. It will be recorded in 6 points (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual). | Baseline, 4, 8 and 12 months. | 
| Bleeding on probing (BOP) | Presence or not of bleeding after probing. It will be recorded in 6 points (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual). | Baseline, 4, 8 and 12 months. | 
| Plaque index (PI) | A plaque developer is used and the presence of plaque is recorded at 6 points per tooth/implant and the percentage of sites with plaque is calculated (O'Leary et al 1972). | Baseline, 4, 8 and 12 months. | 
| Width of keratinized tissue (WKT) | Distance in mm from the mucogingival junction to the gingival margin, measured at the vestibular midpoint. | Baseline and 12 months. | 
| Thickness of keratinized tissue (TKT) | The thickness of the gingiva around the implant is measured approximately 2 mm apical to gingival margin on the facial aspect of the implant. After topical application of anesthetic, the thickness is measured by gently inserting a 27-gauge needle with a rubber stopper in the tip until the underlying hard structure had been contacted. The distance between the tip of the needle and the rubber stopper is measure with a periodontal probe. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zirconia implant, One-piece, Monoblock, Single tooth