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

Ceramic Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352284
• Other study ID #: 2017_03
• Status: Completed
• Phase: N/A
• Start date: May 1, 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: Basque Country University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ceramic Implant

Intervention

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.

Locations

Country	Name	City	State
Spain	Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country	Leioa	Biscay

Sponsors (1)

Lead Sponsor	Collaborator
Miren Vilor Fernández

Country where clinical trial is conducted

Spain, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gahlert M, Röhling S, Wieland M, Eichhorn S, Küchenhoff 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Liñares A, Grize L, Muñoz F, Pippenger BE, Dard M, Domken O, Blanco-Carrión 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Thoma DS, Benic GI, Muñoz F, Kohal R, Sanz Martin I, Cantalapiedra AG, Hämmerle 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gingival recession (REC)	Distance in mm from incisal edge to gingival margin.	Change from baseline (when the crown is cemented) until 12 months.
Secondary	Jemt Papilla index score (JPIS)	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.
Secondary	Surgical complications (SC)	Any complication, as bleeding, dehiscence, loss of suture, etc... that may appear will be collected.	Surgery and the next 7 days.
Secondary	Prosthetic complications (PC)	Any difficulty during the confection of the crown, complications as descementation, chipping, etc... will be registered.	Baseline, 4, 8 and 12 months.
Secondary	Probing depth (PD)	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.
Secondary	Bleeding on probing (BOP)	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.
Secondary	Plaque index (PI)	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.
Secondary	Width of keratinized tissue (WKT)	Distance in mm from the mucogingival junction to the gingival margin, measured at the vestibular midpoint.	Baseline and 12 months.
Secondary	Thickness of keratinized tissue (TKT)	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