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

July 21, 2021 updated by: Miren Vilor Fernández

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Biscay
      • Leioa, Biscay, Spain, 48940
        • Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Straumann Pure Ceramic Implant
Replacement of single tooth gaps with a Zirconia implant
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline until 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival recession (REC)
Time Frame: Change from baseline (when the crown is cemented) until 12 months.
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)
Time Frame: Change from baseline until 12 months.
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)
Time Frame: Surgery and the next 7 days.
Any complication, as bleeding, dehiscence, loss of suture, etc... that may appear will be collected.
Surgery and the next 7 days.
Prosthetic complications (PC)
Time Frame: Baseline, 4, 8 and 12 months.
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)
Time Frame: Baseline, 4, 8 and 12 months.
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)
Time Frame: Baseline, 4, 8 and 12 months.
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)
Time Frame: Baseline, 4, 8 and 12 months.
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)
Time Frame: Baseline and 12 months.
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)
Time Frame: Baseline and 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miren Vilor Fernández

Investigators

  • Study Director: Luis Barbier Herrero, Dr., University of the Basque Country (UPV/EHU)
  • Principal Investigator: Miren Vilor Fernández, Lcda., University of the Basque Country (UPV/EHU)
  • Study Chair: Elena Ruiz de Gopegui Palacios, Lcda., University of the Basque Country (UPV/EHU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2014

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

November 19, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (ACTUAL)

November 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017_03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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