Evaluation of Mandibular Posterior Zirconia Crowns With Different Ti-Base Surface Treatments.

NCT07456995 | Completed DMC

• 1 other identifier: PRO 4.4.1.
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Jaw, Edentulous, Partially; Tooth Loss; Molar Teeth; Dental Implant

Keywords

Ti-Base Abutment; Zirconia Crown; Tribochemical Silica Coating; Surface Treatment; Screw-Retained Restoration

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (1 week post-cementation), 6 months, and 12 months.

Secondary Outcomes (2)

• Modified Plaque Index (mPI)

  12 months.

• Modified Sulcus Bleeding Index (mSBI)

  12 months

Study Arms (3)

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.

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).

Device: Tribochemical silica coating and Z-Prime Plus.

Interventions

Tribochemical silica coating. DEVICE

Surface treatment of titanium base implant abutment using 30 um SiO2 - Al2O3 particles at 2.0 bar pressure.

Also known as: CoJet Sand.

Intervention Group II

Tribochemical silica coating and Z-Prime Plus. DEVICE

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.

Also known as: CoJet Sand and Z-Prime Plus.

Intervention Group III

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Poor oral hygiene
• Severe wear facets, clenching, or bruxism
• Heavy smokers (\>10 cigarettes/day)

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

MSA University, Faculty of Dentistry

Giza, Giza Governorate, 14512, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40884315 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous, Partially; Tooth Loss

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases; Periodontal Diseases

Study Officials

• Dina Elawady, PhD / Asst. Prof.

  MSA University, Faculty of Dentistry

  STUDY CHAIR

• Hesham Amr, Ph.D

  MSA University, Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Who will be blinded after assignment to interventions: Trial participants Outcome assessors Data analysts Statistician How blinding will be achieved: Blinding will be maintained by using identical looking materials and procedures for both intervention groups and coding the groups as Ⅰ and Ⅱ and Ⅲ without revealing the content.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master candidate

Model Details: 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).

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 9, 2026
• Study Start: January 8, 2025
• Primary Completion: January 12, 2026
• Study Completion: February 12, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)