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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-01

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Ceramic Implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Straumann Pure Ceramic Implant

Replacement of single tooth gaps with a Zirconia implant

Group Type EXPERIMENTAL

Straumann Pure Ceramic Implant

Intervention Type DEVICE

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.

Interventions

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Straumann Pure Ceramic Implant

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Miren Vilor Fernández

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR