Jaw, Edentulous, PartiallyRCTNCT07456995
Evaluation of Mandibular Posterior Zirconia Crowns With Different Ti-Base Surface Treatments.
A study testing Tribochemical silica coating. and Tribochemical silica coating and Z-Prime Plus. in people with Jaw, Edentulous, Partially and Tooth Loss, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
This clinical trial evaluates how different surface treatments on a metal base (Ti-Base) affect the success of dental crowns on implants. Patients receiving a zirconia crown for a missing lower back tooth are divided into three groups: one group receives no special treatment on the metal base, one group receives a… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially, Tooth Loss, Molar Teeth
- What is being tested?
- Tribochemical silica coating. and Tribochemical silica coating and Z-Prime Plus.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jan 2025to 12 Feb 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 55 years
- Missing mandibular first molar with opposing natural teeth
- Good oral hygiene and general health (ASA I or II)
- Smoking ≤ 10 cigarettes/day
Who cannot join
- Poor oral hygiene
- Severe wear facets, clenching, or bruxism
- Heavy smokers (>10 cigarettes/day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Mandibular Posterior Screw-retained Zirconia Crown With Various Ti-Base Abutment Surface Treatments: Randomized Controlled Clinical Trial
This clinical trial evaluates how different surface treatments on a metal base (Ti-Base) affect the success of dental crowns on implants. Patients receiving a zirconia crown for a missing lower back tooth are divided into three groups: one group receives no special treatment on the metal base, one group receives a silica coating, and the third receives both a silica coating and a chemical primer. The study monitors these crowns for one year to see which treatment best prevents the crown from coming loose or breaking, while also checking the health of the surrounding gums.
Read the detailed description
This is a three-arm, parallel-group, superiority randomized controlled trial. The research question addresses the impact of silica coating (CoJet Sand) and primer (Z-Prime Plus) on the survival of mandibular posterior screw-retained zirconia crowns.+3The primary intervention involves treating the titanium base (Ti-Base) abutment surface using 30-mm $SiO_2-Al_2O_3$ particles at 2.0 bar pressure. The three groups are:Group I (Control): No surface treatment.Group II: Tribochemical silica coating alone.Group III: Tribochemical silica coating followed by Z-Prime Plus application.Survival is evaluated using modified United States Public Health Service (USPHS) criteria at baseline, 6 months, and 12 months. Biological health is assessed via the modified plaque index (mPI) and modified Sulcus Bleeding Index (mSBI).
- Conditions
- Jaw, Edentulous, Partially, Tooth Loss, Molar Teeth, Dental Implant
- Being tested
- Tribochemical silica coating., Tribochemical silica coating and Z-Prime Plus.
- Keywords
- Ti-Base Abutment, Zirconia Crown, Tribochemical Silica Coating, Surface Treatment, Screw-Retained Restoration
- Medical subject headings
- Jaw, Edentulous, Partially, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tribochemical silica coating.Device
Also called CoJet Sand.
Surface treatment of titanium base implant abutment using 30 um SiO2 - Al2O3 particles at 2.0 bar pressure.
Tribochemical silica coating and Z-Prime Plus.Device
Also called CoJet Sand and Z-Prime Plus.
Surface treatment of titanium base implant abutment using 30 um SiO2 - Al2O3 particles at 2.0 bar pressure, followed by the application of Z-Prime Plus primer.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Group I) | No intervention | Patients in this group receive a screw-retained zirconia crown on a titanium base (Ti-Base) abutment that has received no surface treatment. |
| Intervention Group II | Experimental | The surface of the titanium base abutment is treated with tribochemical silica coating using 30-μm $SiO_2-Al_2O_3$ particles (CoJet Sand) at 2.0 bar pressure before the zirconia crown is attached. Receives: Device: Tribochemical silica coating. |
| Intervention Group III | Experimental | The titanium base abutment surface is treated with tribochemical silica coating (30-μm $SiO_2-Al_2O_3$ particles at 2.0 bar pressure) followed by the application of a chemical primer (Z-Prime Plus). Receives: Device: Tribochemical silica coating and Z-Prime Plus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of screw-retained zirconia crown restorations.
Evaluation of the restoration using modified United States Public Health Service (USPHS) criteria, specifically assessing fracture behavior, decementation, anatomical form, and marginal adaptation.
Measured: Baseline (1 week post-cementation), 6 months, and 12 months.
Secondary outcomes (2)
Modified Plaque Index (mPI)
Evaluation of peri-implant health using the modified Plaque Index, scored from 0 to 3.
Measured: 12 months.
Modified Sulcus Bleeding Index (mSBI)
Evaluation of peri-implant health using the modified Sulcus Bleeding Index, scored from 0 to 3.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start8 Jan 2025
- Primary completion12 Jan 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a three-arm, parallel-group, superiority randomized controlled clinical trial. Participants are allocated with a 1:1 ratio to one of three groups to evaluate the impact of different Ti-Base abutment surface treatments on the survival of screw-retained zirconia crowns. The three study arms are: Control Group (Group I): Titanium base abutment without any surface treatment. Intervention Group II: Titanium base abutment treated with Tribochemical silica coating (CoJet Sand) at 2.0 bar pressure. Intervention Group III: Titanium base abutment treated with Tribochemical silica coating (CoJet Sand) at 2.0 bar pressure followed by the application of a primer (Z-Prime Plus). The primary outcome is the survival of the restorations measured using modified USPHS criteria over a 1-year follow-up period . secondary outcomes include biological parameters measured by the modified plaque index (mPI) and modified Sulcus Bleeding Index (mSBI).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MohamedTarek Abdeltawab Salam, October University for Modern Sciences and Arts
- Investigators
- Dina Elawady, PhD / Asst. Prof., Study chair, MSA University, Faculty of DentistryHesham Amr, Ph.D, Study chair, MSA University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456995
- Sponsor's protocol ID
- PRO 4.4.1.
- Acronym
- RCT
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oktay F, Yanikoglu N, Bayindir F. Investigation of the Effect of Different Surface Treatments Applied to Titanium Dental Implant Abutments on the Retention of CAD/CAM Zirconium-Supported Ceramic Crowns. Niger J Clin Pract. 2025 Aug 1;28(8):880-888. doi: 10.4103/njcp.njcp_41_24. Epub 2025 Aug 30.
PubMed 40884315
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Mandibular Posterior Screw-retained Zirconia Crown With Various Ti-Base Abutment Surface Treatments: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07456995
- Acronym / sponsor ID
- RCT / PRO 4.4.1.
- Conditions
- Jaw, Edentulous, Partially, Tooth Loss, Molar Teeth, Dental Implant
- Keywords
- Ti-Base Abutment, Zirconia Crown, Tribochemical Silica Coating, Surface Treatment, Screw-Retained Restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 9 Mar 2026 (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.
This clinical trial evaluates how different surface treatments on a metal base (Ti-Base) affect the success of dental crowns on implants. Patients receiving a zirconia crown for a missing lower back tooth are divided into three groups: one group receives no special treatment on the metal base, one group receives a silica coating, and the third receives both a silica coating and a chemical primer. The study monitors these crowns for one year to see which treatment best prevents the crown from coming loose or breaking, while also checking the health of the surrounding gums.
Detailed description
This is a three-arm, parallel-group, superiority randomized controlled trial. The research question addresses the impact of silica coating (CoJet Sand) and primer (Z-Prime Plus) on the survival of mandibular posterior screw-retained zirconia crowns.+3The primary intervention involves treating the titanium base (Ti-Base) abutment surface using 30-mm $SiO_2-Al_2O_3$ particles at 2.0 bar pressure. The three groups are:Group I (Control): No surface treatment.Group II: Tribochemical silica coating alone.Group III: Tribochemical silica coating followed by Z-Prime Plus application.Survival is evaluated using modified United States Public Health Service (USPHS) criteria at baseline, 6 months, and 12 months. Biological health is assessed via the modified plaque index (mPI) and modified Sulcus Bleeding Index (mSBI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a three-arm, parallel-group, superiority randomized controlled clinical trial. Participants are allocated with a 1:1 ratio to one of three groups to evaluate the impact of different Ti-Base abutment surface treatments on the survival of screw-retained zirconia crowns. The three study arms are: Control Group (Group I): Titanium base abutment without any surface treatment. Intervention Group II: Titanium base abutment treated with Tribochemical silica coating (CoJet Sand) at 2.0 bar pressure. Intervention Group III: Titanium base abutment treated with Tribochemical silica coating (CoJet Sand) at 2.0 bar pressure followed by the application of a primer (Z-Prime Plus). The primary outcome is the survival of the restorations measured using modified USPHS criteria over a 1-year follow-up period . secondary outcomes include biological parameters measured by the modified plaque index (mPI) and modified Sulcus Bleeding Index (mSBI).
| Arm | Type | Receives |
|---|---|---|
| Control Group (Group I) | No intervention | –Patients in this group receive a screw-retained zirconia crown on a titanium base (Ti-Base) abutment that has received no surface treatment. |
| Intervention Group II | Experimental | Device: Tribochemical silica coating.The surface of the titanium base abutment is treated with tribochemical silica coating using 30-μm $SiO_2-Al_2O_3$ particles (CoJet Sand) at 2.0 bar pressure before the zirconia crown is attached. |
| Intervention Group III | Experimental | Device: Tribochemical silica coating and Z-Prime Plus.The titanium base abutment surface is treated with tribochemical silica coating (30-μm $SiO_2-Al_2O_3$ particles at 2.0 bar pressure) followed by the application of a chemical primer (Z-Prime Plus). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 - 55 years
- Missing mandibular first molar with opposing natural teeth
- Good oral hygiene and general health (ASA I or II)
- Smoking ≤ 10 cigarettes/day
Key exclusion criteria (3 listed)
- Poor oral hygiene
- Severe wear facets, clenching, or bruxism
- Heavy smokers (>10 cigarettes/day)
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 |
|---|---|---|
| Tribochemical silica coating.Also: CoJet Sand.Surface treatment of titanium base implant abutment using 30 um SiO2 - Al2O3 particles at 2.0 bar pressure. | Device | Intervention Group II |
| Tribochemical silica coating and Z-Prime Plus.Also: CoJet Sand and Z-Prime Plus.Surface treatment of titanium base implant abutment using 30 um SiO2 - Al2O3 particles at 2.0 bar pressure, followed by the application of Z-Prime Plus primer. | Device | Intervention Group III |
Primary outcome
Survival of screw-retained zirconia crown restorations.
Time frame: Baseline (1 week post-cementation), 6 months, and 12 months.
Evaluation of the restoration using modified United States Public Health Service (USPHS) criteria, specifically assessing fracture behavior, decementation, anatomical form, and marginal adaptation.
2 secondary outcomes
Modified Plaque Index (mPI)
Time frame: 12 months.
Modified Sulcus Bleeding Index (mSBI)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 40884315Oktay F, Yanikoglu N, Bayindir F. Investigation of the Effect of Different Surface Treatments Applied to Titanium Dental Implant Abutments on the Retention of CAD/CAM Zirconium-Supported Ceramic Crowns. Niger J Clin Pract. 2025 Aug 1;28(8):880-888. doi: 10.4103/njcp.njcp_41_24. Epub 2025 Aug 30.
- Individual participant dataSharing planned: No
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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.
Dina Elawady, PhD / Asst. Prof. study chair
MSA University, Faculty of Dentistry
Hesham Amr, Ph.D study chair
MSA University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tribochemical silica coating. and Tribochemical silica coating and Z-Prime Plus. in people with Jaw, Edentulous, Partially and Tooth Loss, run by October University for Modern Sciences and Arts at 1 site in Egypt.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Mar 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of screw-retained zirconia crown restorations. (time frame: Baseline (1 week post-cementation), 6 months, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07456995, which also lists 1 linked publication.
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 9 Mar 2026.