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

Not Applicable

Completed

• Conditions: Ceramic Implant
• Interventions: Device: Straumann Pure Ceramic Implant

• Registration Number: NCT03352284
• Lead Sponsor: Miren Vilor Fernández

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.

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 Timeline

• Study Start: 2014-05-01
• Study First Submitted: 2017-11-19
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-24
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Straumann Pure Ceramic Implant	Straumann Pure Ceramic Implant	Replacement of single tooth gaps with a Zirconia implant

Primary Outcome Measures

Name	Time	Method
Marginal bone level change (MBLC)	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

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

Trial Locations

Locations (1)

Department of Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country; 🇪🇸 Leioa, Biscay, Spain