Clinical trial NCT03352284: Single Tooth Restoration in the Maxilla Using the Straumann® PURE® Ceramic Implant Monotype: One Year Follow up
Official title: Replacement of Individual Teeth in the Esthetic Zone of Upper Jaw by Using a Monoblock Ceramic Implant: One Year Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ceramic Implant
Keywords: Zirconia implant
One-piece
Monoblock
Single tooth
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Marginal bone level change (MBLC)
timeFrame: Change from baseline until 12 months
Secondary outcomes:
measure: Gingival recession (REC)
timeFrame: Change from baseline (when the crown is cemented) until 12 months.
measure: Jemt Papilla index score (JPIS)
timeFrame: Change from baseline until 12 months.
measure: Surgical complications (SC)
timeFrame: Surgery and the next 7 days.
measure: Prosthetic complications (PC)
timeFrame: Baseline, 4, 8 and 12 months.
measure: Probing depth (PD)
timeFrame: Baseline, 4, 8 and 12 months.
measure: Bleeding on probing (BOP)
timeFrame: Baseline, 4, 8 and 12 months.
measure: Plaque index (PI)
timeFrame: Baseline, 4, 8 and 12 months.
measure: Width of keratinized tissue (WKT)
timeFrame: Baseline and 12 months.
measure: Thickness of keratinized tissue (TKT)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
state: Biscay
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: Luis Antonio Aguirre Zorzano, Dr.
role: STUDY_DIRECTOR
affiliation: University of the Basque Country (UPV/EHU)
name: Luis Barbier Herrero, Dr.
role: STUDY_DIRECTOR
affiliation: University of the Basque Country (UPV/EHU)
name: Miren Vilor Fernández, Lcda.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the Basque Country (UPV/EHU)
name: Ana Maria García de la Fuente, Dr.
role: STUDY_CHAIR
affiliation: University of the Basque Country (UPV/EHU)
name: Ruth Estefanía Fresco, Dr.
role: STUDY_CHAIR
affiliation: University of the Basque Country (UPV/EHU)
name: Xabier Marichalar Mendia, Dr.
role: STUDY_CHAIR
affiliation: University of the Basque Country (UPV/EHU)
name: Elena Ruiz de Gopegui Palacios, Lcda.
role: STUDY_CHAIR
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