Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement

Medical University of Graz33 enrolled

Overview

The purpose of the study is to test whether a two-piece zirconia implant is as reliable in the indication of immediate implant placement as a standard titanium implant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Immediate Implantation of Two-piece Zirconia Dental Implants

Interventions

Implant Straumann® Pure Ceramic Two Piece ImplantDEVICE

Dental implants are placed directly after tooth extraction in the extraction socket.

two-piece titanium implant Neoss® ProActive Tapered ImplantDEVICE

Dental implants are placed directly after tooth extraction in the extraction socket.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Patients giving informed consent to participate in the clinical trial and fulfil the following criteria will be included in the investigation: 1. good oral hygiene standard; 2. good general health; 3. 18 years or older; 4. non-smokers; 5. presence of single-tooth or multiple gaps in the mandible or the maxilla; 6. intact facial bone wall; 7. sufficient bone volume to support an implant of at least 10 mm length. 8. Teeth with removable periapical lesions are included. Exclusion Criteria: Primary exclusion criteria are as follows: 1. parafunctional habits; 2. active periodontitis; 3. smoking; 4. pregnancy; 5. acute or chronic medical conditions for which implant therapy has always been considered a contraindication: uncontrolled diabetes (HbA1c \>8.0%), mucosal disease, untreated periodontitis, immunological disorders, active malignancy, alcoholism, condition after radiation therapy to the head and neck area and antiresorptive therapy. Secondary exclusion criteria will be applied at surgical procedure: 6. loss of facial bone wall due to extraction procedure; 7. insufficient primary stability (less than 32Ncm insertion torque).

Locations (1)

Private practice Prof. Polansky

Graz, Styria, Austria

Outcomes

Primary Outcomes

Change of PTV

Periotest value, Damping capacity assessment. For Periotest values, a customizable healing abutment will be inserted to assess damping capacity.

Time frame: initial, 6 and 12 months after surgical procedure

Change of ISQ

Implant stability quotient. A transducer (smart-peg sensor) will be installed on the top of the implant to measure ISQ with resonance frequency analysis. ISQ will be measured from 4 different sites (facial, lingual, mesial, distal) and calculated as mean of measurements.

Time frame: initial, 6 and 12 months after surgical procedure

Secondary Outcomes

Change of marginal bone loss

A single radiography in paralleling technique will be performed to measure marginal bone loss in millimeters (mm). Individualized x-ray holders will be used to ensure standardization and comparability in radiographic procedure.

Time frame: 6 and 12 months after surgical procedure

Change of PES

In the anterior region (4-4) the pink esthetic score (PES) (Fürhauser et al. 2005) will be used to evaluate the esthetic outcome of the soft tissue around the implant-supported single crowns by awarding seven points for the mesial and distal papilla, soft- tissue level, contour, colour, texture and alveolar process deficiency.

Time frame: 6 and 12 months after surgical procedure

Change of width of keratinized mucosa

The width of keratinized mucosa will be measured in millimetres at the narrowest distance between the mucosal margin and the mucogingival junction at the buccal aspect of the implant using Lugol ́s iodine solution.

Time frame: initial, 12 months after surgical procedure

Change of BOP

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Bleeding on probing will be recorded as positive (BOP+) when bleeding of the peri-implant mucosa is detected at implant (tooth) site-level after probing depth assessment within periodontal status.

Time frame: initial, 6 and 12 months after surgical procedure

Gingival biotype

The tissue phenotype/gingival biotype will be classified at first visit with a conventional periodontal probe. Phenotype will be classified as thin, if the outline of the underlying probe can be seen shining through the buccal mucosa and as thick phenotype, if not.

Time frame: initial

Mean insertion time

Time of implant insertion in seconds (sec).

Time frame: at time of surgery

Change of PROM

Patient related outcome measures. Patients ́ oral-health related quality of life will be assessed before and 12 months after implant therapy by using a 14-point standardized questionnaire (OHIP-14).

Time frame: initial, 12 months after surgical procedure

Complications - biological

Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.

Time frame: at time of surgical procedure, 2 weeks, 6 months and 12 months after surgical procedure

Complications - biological

Time frame: at time of surgical procedure

Complications - biological

Time frame: 2 weeks

Complications - biological

Time frame: 6 months

Complications - biological

Time frame: 12 months

Complications - technical

Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.

Time frame: at time of surgical procedure

Complications - technical

Time frame: 2 weeks

Complications - technical

Time frame: 6 months

Complications - technical

Time frame: 12 months after surgical procedure

Complications - esthetic

Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.

Time frame: at time of surgical procedure

Complications - esthetic

Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.

Time frame: 2 weeks

Complications - esthetic

Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.

Time frame: 6 months

Complications - esthetic

Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.

Time frame: 12 months after surgical procedure