NCT03352284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

5.7 years

First QC Date

November 19, 2017

Last Update Submit

July 21, 2021

Conditions

Ceramic Implant

Keywords

Zirconia implantOne-pieceMonoblockSingle tooth

Outcome Measures

Primary Outcomes (1)

  • Marginal bone level change (MBLC)

    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 Outcomes (9)

  • 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.

  • 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.

  • +4 more secondary outcomes

Study Arms (1)

Straumann Pure Ceramic Implant

EXPERIMENTAL

Replacement of single tooth gaps with a Zirconia implant

Device: Straumann Pure Ceramic Implant

Interventions

Straumann Pure Ceramic ImplantDEVICE

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.

Straumann Pure Ceramic Implant

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country

Leioa, Biscay, 48940, Spain

Location

Related Publications (14)

  • Gahlert M, Roehling S, Sprecher CM, Kniha H, Milz S, Bormann K. In vivo performance of zirconia and titanium implants: a histomorphometric study in mini pig maxillae. Clin Oral Implants Res. 2012 Mar;23(3):281-6. doi: 10.1111/j.1600-0501.2011.02157.x. Epub 2011 Aug 2.

    PMID: 21806681BACKGROUND

  • Kohal RJ, Knauf M, Larsson B, Sahlin H, Butz F. One-piece zirconia oral implants: one-year results from a prospective cohort study. 1. Single tooth replacement. J Clin Periodontol. 2012 Jun;39(6):590-7. doi: 10.1111/j.1600-051X.2012.01876.x. Epub 2012 Apr 23.

    PMID: 22519944BACKGROUND

  • Payer M, Arnetzl V, Kirmeier R, Koller M, Arnetzl G, Jakse N. Immediate provisional restoration of single-piece zirconia implants: a prospective case series - results after 24 months of clinical function. Clin Oral Implants Res. 2013 May;24(5):569-75. doi: 10.1111/j.1600-0501.2012.02425.x. Epub 2012 Feb 15.

    PMID: 22335358BACKGROUND

  • Gahlert M, Burtscher D, Pfundstein G, Grunert I, Kniha H, Roehling S. Dental zirconia implants up to three years in function: a retrospective clinical study and evaluation of prosthetic restorations and failures. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):896-904. doi: 10.11607/jomi.2211.

    PMID: 23748325BACKGROUND

  • Borgonovo AE, Censi R, Vavassori V, Arnaboldi O, Maiorana C, Re D. Zirconia Implants in Esthetic Areas: 4-Year Follow-Up Evaluation Study. Int J Dent. 2015;2015:415029. doi: 10.1155/2015/415029. Epub 2015 Jun 1.

    PMID: 26124836BACKGROUND

  • Gahlert M, Kniha H, Weingart D, Schild S, Gellrich NC, Bormann KH. A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth gaps. Clin Oral Implants Res. 2016 Dec;27(12):e176-e184. doi: 10.1111/clr.12598. Epub 2015 Apr 1.

    PMID: 25827600BACKGROUND

  • Siddiqi A, Kieser JA, De Silva RK, Thomson WM, Duncan WJ. Soft and Hard Tissue Response to Zirconia versus Titanium One-Piece Implants Placed in Alveolar and Palatal Sites: A Randomized Control Trial. Clin Implant Dent Relat Res. 2015 Jun;17(3):483-96. doi: 10.1111/cid.12159. Epub 2013 Sep 23.

    PMID: 24112624BACKGROUND

  • Hashim D, Cionca N, Courvoisier DS, Mombelli A. A systematic review of the clinical survival of zirconia implants. Clin Oral Investig. 2016 Sep;20(7):1403-17. doi: 10.1007/s00784-016-1853-9. Epub 2016 May 24.

    PMID: 27217032BACKGROUND

  • Linares A, Grize L, Munoz F, Pippenger BE, Dard M, Domken O, Blanco-Carrion J. Histological assessment of hard and soft tissues surrounding a novel ceramic implant: a pilot study in the minipig. J Clin Periodontol. 2016 Jun;43(6):538-46. doi: 10.1111/jcpe.12543. Epub 2016 May 2.

    PMID: 26969899BACKGROUND

  • Gahlert M, Rohling S, Wieland M, Eichhorn S, Kuchenhoff H, Kniha H. A comparison study of the osseointegration of zirconia and titanium dental implants. A biomechanical evaluation in the maxilla of pigs. Clin Implant Dent Relat Res. 2010 Dec;12(4):297-305. doi: 10.1111/j.1708-8208.2009.00168.x.

    PMID: 19438936BACKGROUND

  • Oliva J, Oliva X, Oliva JD. Five-year success rate of 831 consecutively placed Zirconia dental implants in humans: a comparison of three different rough surfaces. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):336-44.

    PMID: 20369093BACKGROUND

  • Sicilia A, Cuesta S, Coma G, Arregui I, Guisasola C, Ruiz E, Maestro A. Titanium allergy in dental implant patients: a clinical study on 1500 consecutive patients. Clin Oral Implants Res. 2008 Aug;19(8):823-35. doi: 10.1111/j.1600-0501.2008.01544.x.

    PMID: 18705814BACKGROUND

  • Grassi FR, Capogreco M, Consonni D, Bilardi G, Buti J, Kalemaj Z. Immediate occlusal loading of one-piece zirconia implants: five-year radiographic and clinical evaluation. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):671-80. doi: 10.11607/jomi.3831.

    PMID: 26009919BACKGROUND

  • Thoma DS, Benic GI, Munoz F, Kohal R, Sanz Martin I, Cantalapiedra AG, Hammerle CH, Jung RE. Marginal bone-level alterations of loaded zirconia and titanium dental implants: an experimental study in the dog mandible. Clin Oral Implants Res. 2016 Apr;27(4):412-20. doi: 10.1111/clr.12595. Epub 2015 Apr 10.

    PMID: 25864523BACKGROUND

Study Officials

  • Luis Antonio Aguirre Zorzano, Dr.

    University of the Basque Country (UPV/EHU)

    STUDY DIRECTOR

  • Luis Barbier Herrero, Dr.

    University of the Basque Country (UPV/EHU)

    STUDY DIRECTOR

  • Miren Vilor Fernández, Lcda.

    University of the Basque Country (UPV/EHU)

    PRINCIPAL INVESTIGATOR

  • Ana Maria García de la Fuente, Dr.

    University of the Basque Country (UPV/EHU)

    STUDY CHAIR

  • Ruth Estefanía Fresco, Dr.

    University of the Basque Country (UPV/EHU)

    STUDY CHAIR

  • Xabier Marichalar Mendia, Dr.

    University of the Basque Country (UPV/EHU)

    STUDY CHAIR

  • Elena Ruiz de Gopegui Palacios, Lcda.

    University of the Basque Country (UPV/EHU)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2017

First Posted

November 24, 2017

Study Start

May 1, 2014

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)