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

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ClinicalTrials.gov Identifier: NCT03352284
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Miren Vilor Fernández, Basque Country University

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.

Condition or disease Intervention/treatment
Ceramic Implant Device: Straumann Pure Ceramic Implant

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Replacement of Individual Teeth in the Esthetic Zone of Upper Jaw by Using a Monoblock Ceramic Implant: One Year Follow up
Actual Study Start Date : May 1, 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352284


Contacts
Contact: Miren Vilor Fernández, Lcda. 6757039258 ext 0034 mirenvilor@gmail.com
Contact: Ana María García de la Fuente, Dr. 946012920 ext 0034 anamaria.garciad@ehu.eus

Locations
Spain
Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country Recruiting
Leioa, Biscay, Spain, 48940
Contact: Ana Maria García de la Fuente, Dr.    946012920 ext 0034    anamaria.garciad@ehu.eus   
Contact: Miren Vilor Fernández, Lcda.    675703928 ext 0034    mirenvilor@gmail.com   
Principal Investigator: Miren Vilor Fernández         
Sub-Investigator: Luis Antonio Aguirre Zorzano         
Sub-Investigator: Elena Ruiz de Gopuegui Palacios         
Sub-Investigator: Ana García de la Fuente         
Sub-Investigator: Ruth Estefanía Fresco         
Sub-Investigator: Xabier Marichalar Mendía         
Sponsors and Collaborators
Miren Vilor Fernández
Investigators
Study Director: Luis Antonio Aguirre Zorzano, Dr. Basque Country University
Study Director: Luis Barbier Herrero, Dr. Basque Country University
Principal Investigator: Miren Vilor Fernández, Lcda. Basque Country University
Study Chair: Ana Maria García de la Fuente, Dr. Basque Country University
Study Chair: Ruth Estefanía Fresco, Dr. Basque Country University
Study Chair: Xabier Marichalar Mendia, Dr. Basque Country University
Study Chair: Elena Ruiz de Gopegui Palacios, Lcda. Basque Country University

Publications:

Responsible Party: Miren Vilor Fernández, Principal Investigator, Basque Country University
ClinicalTrials.gov Identifier: NCT03352284     History of Changes
Other Study ID Numbers: 2017_03
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Miren Vilor Fernández, Basque Country University:
Zirconia implant
One-piece
Monoblock
Single tooth