Clinical Evaluation of Mandibular Posterior Screw-retained Zirconia Crown With Various Ti-Base Abutment Surface Treatments: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Survival of screw-retained zirconia crown restorations.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Poor oral hygiene
- •Severe wear facets, clenching, or bruxism
- •Heavy smokers (>10 cigarettes/day)
研究组 & 干预措施
Control Group (Group I)
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
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.
干预措施: Tribochemical silica coating. (Device)
Intervention Group III
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).
干预措施: Tribochemical silica coating and Z-Prime Plus. (Device)
结局指标
主要结局
Survival of screw-retained zirconia crown restorations.
时间窗: 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.
次要结局
- Modified Plaque Index (mPI)(12 months.)
- Modified Sulcus Bleeding Index (mSBI)(12 months)
研究者
MohamedTarek Abdeltawab Salam
Master candidate
October University for Modern Sciences and Arts