Evaluation of Survival and Success Rates of Zirzonia Dental Implants

NCT05105113 | Unknown DMC

• 1 other identifier: 0382-19 -RMB CTIL
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Survival and success rates of Zirconia dental implants compared with Titanium implants (Two-Piece Zirconia implants)

Conditions

Dental Implantation

Outcome Measures

Primary Outcomes (1)

• Evaluate Tav- implant survival.

  Implant survival means that implants are still in the mouth. at the time of examination, regardless of the state of the prosthesis or patient satisfaction.

  12 months

Secondary Outcomes (5)

• Evaluate Tav-Implant probing depth (IPD)

  12 months.

• Evaluate Tav-implant Bleeding on probe (BOP)

  12 months.

• Evaluate Tav-implant Gingival index (GI) changes.

  4 weeks, 12 weeks, 12 months

• Evaluate Tav-implant Plaque index (PI) changes.

  4 weeks, 12 weeks, 12 months

• Evaluate Tav-implant Pink Esthetic Score (PES) changes.

  4 weeks, 12 weeks, 12 months.

Study Arms (1)

Zirconia dental implant

EXPERIMENTAL

Patients treated with zirconia dental implant (Tav-dental) to replace missing tooth

Procedure: Zirconia dental implant installation surgery

Interventions

Zirconia dental implant installation surgery PROCEDURE

Dental implant installation surgery using zirconia one-piece implant (Tav-dental)

Zirconia dental implant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have voluntarily signed the informed consent form.
• Male or female patient aged ≥18 Years old.
• Replacing a missing tooth by use of implant supported restoration in implantation sites that do not require extensive augmentation procedure.
• Good primary implant stability at implant placement (35N and more).
• Compliance with study schedules and arrival at study visits.

You may not qualify if:

• Pregnant or lactating women.
• Imbalance diabetes.
• Head and neck rediation therapy.
• Active Periodontal disease and caries.
• Patient in need of tooth extraction and immediat implantation.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Study Officials

• Hadar Zigdon, DMD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadar Zigdon, DMD

CONTACT

9727772983; h_zigdon@rambam.health.gov.il

Eli Machtei, DMD

CONTACT

9727772983; machtei@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: November 3, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

IL (1)