Ceramic ImplantNCT03352284

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

A study testing Straumann Pure Ceramic Implant in people with Ceramic Implant, run by Miren Vilor Fernández at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Ceramic Implant
What is being tested?: Straumann Pure Ceramic Implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSpain
Study dates: 1 May 2014to 31 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions: Ceramic Implant
Being tested: Straumann Pure Ceramic Implant
Keywords: Zirconia implant, One-piece, Monoblock, Single tooth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03352284
Study group	Role	What they receive
Straumann Pure Ceramic Implant	Experimental	Replacement of single tooth gaps with a Zirconia implant Receives: Device: Straumann Pure Ceramic Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline until 12 months

Secondary outcomes (9)

Gingival recession (REC)
Distance in mm from incisal edge to gingival margin.
Measured: Change from baseline (when the crown is cemented) until 12 months.
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.
Measured: Change from baseline until 12 months.
Surgical complications (SC)
Any complication, as bleeding, dehiscence, loss of suture, etc... that may appear will be collected.
Measured: Surgery and the next 7 days.
Prosthetic complications (PC)
Any difficulty during the confection of the crown, complications as descementation, chipping, etc... will be registered.
Measured: Baseline, 4, 8 and 12 months.
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).
Measured: Baseline, 4, 8 and 12 months.
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).
Measured: Baseline, 4, 8 and 12 months.
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).
Measured: Baseline, 4, 8 and 12 months.
Width of keratinized tissue (WKT)
Distance in mm from the mucogingival junction to the gingival margin, measured at the vestibular midpoint.
Measured: Baseline and 12 months.
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.
Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201431 Dec 2020

First posted24 Nov 2017
Study start1 May 2014
Primary completion31 Dec 2019
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Ceramic ImplantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03352284
Sponsor's protocol ID: 2017_03
Status last verified: Jul 2021
First submitted: 19 Nov 2017
Last updated: 22 Jul 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21806681
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.
PubMed 22519944
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.
PubMed 22335358
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.
PubMed 23748325
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.
PubMed 26124836
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.
PubMed 25827600
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.
PubMed 24112624
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.
PubMed 27217032
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.
PubMed 26969899
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.
PubMed 19438936
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.
PubMed 20369093
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.
PubMed 18705814
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.
PubMed 26009919
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.
PubMed 25864523

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ceramic Implant trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Replacement of Individual Teeth in the Esthetic Zone of Upper Jaw by Using a Monoblock Ceramic Implant: One Year Follow up
ClinicalTrials.gov ID: NCT03352284
Acronym / sponsor ID: 2017_03
Conditions: Ceramic Implant
Keywords: Zirconia implant, One-piece, Monoblock, Single tooth
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Miren Vilor FernándezUniversity, hospital or other
Study start: 1 May 2014 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 24 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as unit of analysis the implant.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Straumann Pure Ceramic Implant	Experimental	Device: Straumann Pure Ceramic ImplantReplacement of single tooth gaps with a Zirconia implant

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Straumann Pure Ceramic ImplantThe 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.	Device	Straumann Pure Ceramic Implant

Primary outcome

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.

9 secondary outcomes

Gingival recession (REC)
Time frame: Change from baseline (when the crown is cemented) until 12 months.
Jemt Papilla index score (JPIS)
Time frame: Change from baseline until 12 months.
Surgical complications (SC)
Time frame: Surgery and the next 7 days.
Prosthetic complications (PC)
Time frame: Baseline, 4, 8 and 12 months.
Probing depth (PD)
Time frame: Baseline, 4, 8 and 12 months.
Bleeding on probing (BOP)
Time frame: Baseline, 4, 8 and 12 months.
Plaque index (PI)
Time frame: Baseline, 4, 8 and 12 months.
Width of keratinized tissue (WKT)
Time frame: Baseline and 12 months.
Thickness of keratinized tissue (TKT)
Time frame: Baseline and 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
Background: PubMed 21806681Gahlert 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.
Background: PubMed 22519944Kohal 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.
Background: PubMed 22335358Payer 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.
Background: PubMed 23748325Gahlert 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.
Background: PubMed 26124836Borgonovo 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.
Background: PubMed 25827600Gahlert 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.
Background: PubMed 24112624Siddiqi 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.
Background: PubMed 27217032Hashim 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.
Background: PubMed 26969899Linares 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.
Background: PubMed 19438936Gahlert 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.
Background: PubMed 20369093Oliva 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.
Background: PubMed 18705814Sicilia 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luis Antonio Aguirre Zorzano, Dr. study director

University of the Basque Country (UPV/EHU)

Luis Barbier Herrero, Dr. study director

University of the Basque Country (UPV/EHU)

Miren Vilor Fernández, Lcda. principal investigator

University of the Basque Country (UPV/EHU)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Straumann Pure Ceramic Implant in people with Ceramic Implant, run by Miren Vilor Fernández at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Marginal bone level change (MBLC) (time frame: Change from baseline until 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03352284, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.