Clinical trial NCT06314425: Zirconia Implants: Practice-based Evidence
Official title: Prospective Clinical Series With Zirconia Implants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Implants
Ceramic Implant
Keywords: ceramic implants
titanium implants
peri-implantitis
marginal bone loss
soft tissue
bone augmentation
immediate implantation
dental implants
immediate loading
Lead sponsor: Swiss Dental Solutions
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective case series clinical study to examine the effectiveness of Ceramic dental implants manufactured by Swiss Dental Solutions (SDS). Participants with an indication from the dentist for teeth extraction and replacement are invited to participate in this study. Participating in this study will involve the use of dental implants manufactured by Swiss Dental Solutions (SDS zirconia dental implants), submission of the case data, including pre-operative information, intra-operative details, and post-operative follow-up data, to the study site and its collaborating partners.

The SDS zirconia dental implants used in this research are FDA cleared devices that are available for dental treatments.

Detailed description: To evaluate the effectiveness of one-piece ceramic implants placed into fresh extraction sockets and provide practical clinical evidence, the investigators will assess their performance in defined clinical settings, encompassing a variety of clinical situations, patients, and practitioners. This evaluation, conducted according to a precise surgical and treatment protocol, considers factors such as patient and clinician variability and long-term outcomes in routine clinical practice.

Study Question:

The cumulative survival rate (CSR), Marginal Bone Level (MBL) and Pink Esthetic Score (PES) of one-piece ceramic implants supporting crowns during a 12-month follow-up period will be determined.

Eligibility criteria: Inclusion Criteria:

* The need for implant placement in position of single or multiple teeth to be extracted and to replace up to 3 teeth
* Availability of patient for a minimum follow-up of one year following implantation
* Availability of complete follow-up data in medical records
* Availability of post-operative and follow-up periapical radiographs

Exclusion Criteria:

* History of head and neck irradiation
* History of bisphosphonate or medications that induce osteonecrosis of the jaw
* Untreated systemic diseases that are known to affect wound healing, such as uncontrolled diabetes mellitus
* Immunocompromised or immunoproliferative diseases
* Heavy Smoking of \&gt;10 cigarettes per day

Primary outcomes:
measure: Cumulative Survival Rate (CSR)
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Marginal Bone Loss (MBL)
timeFrame: 12-month follow-up
Other outcomes:
measure: Pink Esthetic Score (PES)
timeFrame: 12-month follow-up
Locations:
city: Englewood Cliffs
country: United States
facility: Vizstara Professional Education
state: New Jersey
Study officials:
affiliation: Vizstara Professional Education, Clinical and R &amp; D
name: Etyene Schnurr, DMD PhD DSc MSc
role: STUDY_DIRECTOR
References: