Replacement of Individual Teeth in the Esthetic Zone of Upper Jaw by Using a Monoblock Ceramic Implant: One Year Follow up
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ceramic Implant
- Sponsor
- Miren Vilor Fernández
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Marginal bone level change (MBLC)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Miren Vilor Fernández
Principal Investigator
University of the Basque Country (UPV/EHU)
Eligibility Criteria
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
Outcomes
Primary Outcomes
Marginal bone level change (MBLC)
Time Frame: Change from baseline until 12 months
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.
Secondary Outcomes
- Gingival recession (REC)(Change from baseline (when the crown is cemented) until 12 months.)
- Jemt Papilla index score (JPIS)(Change from baseline until 12 months.)
- Bleeding on probing (BOP)(Baseline, 4, 8 and 12 months.)
- Plaque index (PI)(Baseline, 4, 8 and 12 months.)
- Width of keratinized tissue (WKT)(Baseline and 12 months.)
- Thickness of keratinized tissue (TKT)(Baseline and 12 months)
- Surgical complications (SC)(Surgery and the next 7 days.)
- Prosthetic complications (PC)(Baseline, 4, 8 and 12 months.)
- Probing depth (PD)(Baseline, 4, 8 and 12 months.)