Dental Implant, Jaw, Edentulous, Partially, Molar Teeth, Tooth Loss
Conditions
Keywords
Ti-Base Abutment, Zirconia Crown, Tribochemical Silica Coating, Surface Treatment, Screw-Retained Restoration
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.
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).
Interventions
DEVICETribochemical silica coating.
Surface treatment of titanium base implant abutment using 30 um SiO2 - Al2O3 particles at 2.0 bar pressure.
DEVICETribochemical silica coating 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.
Sponsors
October University for Modern Sciences and Arts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Poor oral hygiene * Severe wear facets, clenching, or bruxism * Heavy smokers (\>10 cigarettes/day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of screw-retained zirconia crown restorations. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Plaque Index (mPI) | 12 months. | Evaluation of peri-implant health using the modified Plaque Index, scored from 0 to 3. |
| Modified Sulcus Bleeding Index (mSBI) | 12 months | Evaluation of peri-implant health using the modified Sulcus Bleeding Index, scored from 0 to 3. |
Countries
Egypt
Contacts
STUDY_CHAIRDina Elawady, PhD / Asst. Prof.
MSA University, Faculty of Dentistry
STUDY_CHAIRHesham Amr, Ph.D
MSA University, Faculty of Dentistry
Outcome results
None listed