Dental Implantation Clinical Trial
Official title:
Evaluation of Survival and Success Rates of Zirzonia Dental Implants
Survival and success rates of Zirconia dental implants compared with Titanium implants (Two-Piece Zirconia implants)
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Evaluate Tav-Implant probing depth (IPD) | refers to the distance from the gingival margin to pocket base (dental pocket). | 12 months. | |
Secondary | Evaluate Tav-implant Bleeding on probe (BOP) | presence or absence of bleeding of the dental pocket after probing around the implant. | 12 months. | |
Secondary | Evaluate Tav-implant Gingival index (GI) changes. | Gingival index (GI) (Löe and Sillness, 1963): scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding, the score is given by visual examining the gingiva around the implant. | 4 weeks, 12 weeks, 12 months | |
Secondary | Evaluate Tav-implant Plaque index (PI) changes. | Plaque index (PI) (Sillness and Löe, 1964): The plaque index assesses the amount of dental plaque visible around the teeth and implants, scoring each site on 0 to 3 scale. | 4 weeks, 12 weeks, 12 months | |
Secondary | Evaluate Tav-implant Pink Esthetic Score (PES) changes. | Pink Esthetic Score (PES) (Fürhauser 2005): evaluates the esthetic outcome of soft tissue around implant-supported single crowns, the score is given by visual examining the gingiva around the implant.
A score of 2, 1, or 0 is assigned to all seven parameters. A score of 0 indicated the worst and a score of 2 indicated the best result for each variable, therefore the highest possible score of 14 denoted perfect peri-implant soft tissues. |
4 weeks, 12 weeks, 12 months. |
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