Dental ImplantationNCT05105113
Evaluation of Survival and Success Rates of Zirzonia Dental Implants
A study testing Zirconia dental implant installation surgery in people with Dental Implantation, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Survival and success rates of Zirconia dental implants compared with Titanium implants (Two-Piece Zirconia implants) Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation
- What is being tested?
- Zirconia dental implant installation surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Survival and success rates of Zirconia dental implants compared with Titanium implants (Two-Piece Zirconia implants)
Read the detailed description
In the last three decades the use of dental implants to support oral rehabilitation has become a common treatment in dentistry and orthopedics.
The implants are made of titanium alloy and have shown high safety and effectiveness.
However, the gray color of the implant may be reflected through the gums and impair aesthetics in the areas of the front of the mouth.
Against this background, in recent years, implant companies have developed zirconia implants, which are white in color.
Studies have shown an aesthetic advantage for zirconia implants and zirconia structures compared to titanium when placed in an aesthetic area in patients with thin gums.
Zirconia implants are resistant to high forces and like titanium implants they undergo osteointegration into the bone, another study in dogs demonstrated an improvement in the soft and hard tissue integration in zirconia implants compared to titanium. In addition to the aesthetic benefit, zirconia implants may have an advantage in a less inflammatory response in the tissues surrounding the implant. In recent years, a number of studies have been published showing detachment of titanium particles from titanium implants which cause an inflammatory response and the absorption of supporting bone around the implant. In addition, several laboratory studies have shown an advantage for zirconia implants in terms of bacterial adsorption to the surface of the implant compared to titanium implants. Studies have been found that show higher pathogenic bacterial adsorption to titanium compared to zirconia.
TavMedical was established in 1975 and mainly specializes in the production, development and marketing of consumable medical products.
In 2011 the company began to develop dental products including implants, parts and utensils.
The company specializes mainly in zirconia dental products. Titanium implants are common and well-known implants and the company focuses its activities on promoting zirconia implants, which constitute a significant differentiation from the titanium implants currently sold in the world.
The purpose of developing zirconia dental implants is to introduce zirconia implants as a preferred alternative to the dental implants currently sold from titanium.
Also, improving the implant treatments currently offered by providing an alternative with high aesthetic results. Patients in the modern age are characterized by a high awareness of their health condition and their demand for treatment with high aesthetic results.
The natural tooth and being a metal-free material adapted to a growing trend all over the world.
Research Hypothesis - Based on the literature, the success rate and survival of zirconia implants is similar to titanium implants and stands at about 95% chance of survival.
Thus differences in the survival and success of titanium implants compared to zirconia are not expected.
Clinical inflammation markers and low-level pro-inflammatory cytokines were found around zirconia implants compared to titanium implants.
Aim of the study - Comparison of survival, success and signs of inflammation of zirconia implants compared to titanium implants.
- Conditions
- Dental Implantation
- Being tested
- Zirconia dental implant installation surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia dental implant installation surgeryProcedure or surgery
Dental implant installation surgery using zirconia one-piece implant (Tav-dental)
| Study group | Role | What they receive |
|---|---|---|
| Zirconia dental implant | Experimental | Patients treated with zirconia dental implant (Tav-dental) to replace missing tooth Receives: Procedure: Zirconia dental implant installation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Evaluate Tav-Implant probing depth (IPD)
refers to the distance from the gingival margin to pocket base (dental pocket).
Measured: 12 months.
Evaluate Tav-implant Bleeding on probe (BOP)
presence or absence of bleeding of the dental pocket after probing around the implant.
Measured: 12 months.
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.
Measured: 4 weeks, 12 weeks, 12 months
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.
Measured: 4 weeks, 12 weeks, 12 months
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.
Measured: 4 weeks, 12 weeks, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadar Zigdon, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105113
- Sponsor's protocol ID
- 0382-19 -RMB CTIL
- Status last verified
- Apr 2023
- First submitted
- 2 Sep 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Survival and Success Rates of Zirzonia Dental Implants
- ClinicalTrials.gov ID
- NCT05105113
- Acronym / sponsor ID
- 0382-19 -RMB CTIL
- Conditions
- Dental Implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Survival and success rates of Zirconia dental implants compared with Titanium implants (Two-Piece Zirconia implants)
Detailed description
In the last three decades the use of dental implants to support oral rehabilitation has become a common treatment in dentistry and orthopedics.
The implants are made of titanium alloy and have shown high safety and effectiveness.
However, the gray color of the implant may be reflected through the gums and impair aesthetics in the areas of the front of the mouth.
Against this background, in recent years, implant companies have developed zirconia implants, which are white in color.
Studies have shown an aesthetic advantage for zirconia implants and zirconia structures compared to titanium when placed in an aesthetic area in patients with thin gums.
Zirconia implants are resistant to high forces and like titanium implants they undergo osteointegration into the bone, another study in dogs demonstrated an improvement in the soft and hard tissue integration in zirconia implants compared to titanium. In addition to the aesthetic benefit, zirconia implants may have an advantage in a less inflammatory response in the tissues surrounding the implant. In recent years, a number of studies have been published showing detachment of titanium particles from titanium implants which cause an inflammatory response and the absorption of supporting bone around the implant. In addition, several laboratory studies have shown an advantage for zirconia implants in terms of bacterial adsorption to the surface of the implant compared to titanium implants. Studies have been found that show higher pathogenic bacterial adsorption to titanium compared to zirconia.
TavMedical was established in 1975 and mainly specializes in the production, development and marketing of consumable medical products.
In 2011 the company began to develop dental products including implants, parts and utensils.
The company specializes mainly in zirconia dental products. Titanium implants are common and well-known implants and the company focuses its activities on promoting zirconia implants, which constitute a significant differentiation from the titanium implants currently sold in the world.
The purpose of developing zirconia dental implants is to introduce zirconia implants as a preferred alternative to the dental implants currently sold from titanium.
Also, improving the implant treatments currently offered by providing an alternative with high aesthetic results. Patients in the modern age are characterized by a high awareness of their health condition and their demand for treatment with high aesthetic results.
The natural tooth and being a metal-free material adapted to a growing trend all over the world.
Research Hypothesis - Based on the literature, the success rate and survival of zirconia implants is similar to titanium implants and stands at about 95% chance of survival.
Thus differences in the survival and success of titanium implants compared to zirconia are not expected.
Clinical inflammation markers and low-level pro-inflammatory cytokines were found around zirconia implants compared to titanium implants.
Aim of the study - Comparison of survival, success and signs of inflammation of zirconia implants compared to titanium implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zirconia dental implant | Experimental | Procedure: Zirconia dental implant installation surgeryPatients treated with zirconia dental implant (Tav-dental) to replace missing tooth |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconia dental implant installation surgeryDental implant installation surgery using zirconia one-piece implant (Tav-dental) | Procedure or surgery | Zirconia dental implant |
Primary outcome
Evaluate Tav- implant survival.
Time frame: 12 months
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.
5 secondary outcomes
Evaluate Tav-Implant probing depth (IPD)
Time frame: 12 months.
Evaluate Tav-implant Bleeding on probe (BOP)
Time frame: 12 months.
Evaluate Tav-implant Gingival index (GI) changes.
Time frame: 4 weeks, 12 weeks, 12 months
Evaluate Tav-implant Plaque index (PI) changes.
Time frame: 4 weeks, 12 weeks, 12 months
Evaluate Tav-implant Pink Esthetic Score (PES) changes.
Time frame: 4 weeks, 12 weeks, 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Zigdon, DMD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia dental implant installation surgery in people with Dental Implantation, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadar Zigdon, DMD (9727772983, h_zigdon@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Tav- implant survival. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.