Clinical trial NCT05369299: Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement
Official title: Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement - a Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Immediate Implantation of Two-piece Zirconia Dental Implants
Keywords: zirconium oxide
Dental Implants
Prospective Studies
Osseointegration
Resonance Frequency Analysis
Patient Reported Outcome Measures
Esthetics
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective controlled randomized trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change of PTV
timeFrame: initial, 6 and 12 months after surgical procedure
measure: Change of ISQ
timeFrame: initial, 6 and 12 months after surgical procedure
Secondary outcomes:
measure: Change of marginal bone loss
timeFrame: 6 and 12 months after surgical procedure
measure: Change of PES
timeFrame: 6 and 12 months after surgical procedure
measure: Change of width of keratinized mucosa
timeFrame: initial, 12 months after surgical procedure
measure: Change of BOP
timeFrame: initial, 6 and 12 months after surgical procedure
measure: Gingival biotype
timeFrame: initial
measure: Mean insertion time
timeFrame: at time of surgery
measure: Change of PROM
timeFrame: initial, 12 months after surgical procedure
measure: Complications - biological
timeFrame: at time of surgical procedure, 2 weeks, 6 months and 12 months after surgical procedure
measure: Complications - biological
timeFrame: at time of surgical procedure
measure: Complications - biological
timeFrame: 2 weeks
measure: Complications - biological
timeFrame: 6 months
measure: Complications - biological
timeFrame: 12 months
measure: Complications - technical
timeFrame: at time of surgical procedure
measure: Complications - technical
timeFrame: 2 weeks
measure: Complications - technical
timeFrame: 6 months
measure: Complications - technical
timeFrame: 12 months after surgical procedure
measure: Complications - esthetic
timeFrame: at time of surgical procedure
measure: Complications - esthetic
timeFrame: 2 weeks
measure: Complications - esthetic
timeFrame: 6 months
measure: Complications - esthetic
timeFrame: 12 months after surgical procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Private practice Prof. Polansky
state: Styria
Study officials:
affiliation: Department of Dentistry and Oral Health, Medical University of Graz
name: Raoul Polansky, DMD
role: PRINCIPAL_INVESTIGATOR
References: