Health of Peri-implant Tissues Adjacent to Glazed or Polished Zirconia Surface: a Randomized, Intra-subject, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline Hygiene Index at six months
研究概览
简要总结
Background: The control and maintenance of implants, bone tissue and soft tissue are fundamental for the clinical success of implant prostheses (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time.
Objective: To prospectively assess whether the peri-implant health of soft and hard tissues adjacent to monolithic zirconia PSIs varies with the type of surface finish (glazed or polished). It will also be evaluated if the patient perceives any clinical, comfort or satisfaction difference.
Methodology: The study design is a randomized, prospective, paired clinical trial, with intra-subject comparison. The sample will consist of consecutive patients in need and indication for treatment with monolithic zirconia PSIs, attended at the Military Policlinic of Porto Alegre and in a private practice by a single specialist researcher. For each PSI, the allocation of a glazed or polished surface in contact with the soft gingival tissue will be randomized on the mesial and distal sides of the crown. Data will be collected by routine clinical and radiographic examination with a focus on peri-implant health (hygiene index, gingival bleeding index, crestal bone level), satisfaction questionnaire and intraoral images (thermography and photographs), after one week of installation of the PSI and in six months, one year and two years. The data will be analyzed by descriptive and inferential statistics, at the significance level of 0.05.
详细描述
The control and maintenance of implant, bone and soft tissue are fundamental for the clinical success of prostheses over implants (PSIs). The type of ceramic surface finish can modify the biological response of peri-implant tissues adjacent to PSIs over time.
AIM To prospectively assess whether the peri-implant health of soft and hard tissue adjacent to monolithic PSIs varies with the type of surface finish (glazed or polished).
METHODS The study design is a randomized, prospective, paired, clinical trial with intra-subject comparison, and the research protocol will follow the Resolution 466/12 of the Brazilian National Health Council and the Declaration of Helsinki.
Sample A non-probabilistic sample will consist of consecutive patients in need of treatment with unitary PSIs made of monolithic zirconia, being attended at the Military Polyclinic of Porto Alegre and in a private practice by the same specialist researcher (DBS). Patients will be selected according to the eligibility criteria.
Sample size calculation: In the systematic review of Linkevicius and Vaitelis (2015) on the effect of zirconia or titanium abutments on peri-implant tissues, the 11 clinical studies included for biological outcomes had samples from 11 to 81 patients, with 11 to 45 abutments. In a total of 145 zirconia abutments, 12 (8.2%) had biological complications. There is no current clinical studies on glaze and PSI polishing in monolithic zirconia and outcomes of peri-implant health. So, a priori, the initial sample will consist of 30 PSIs (30 pairs to be compared: Glaze vs. Polishing). The definitive sample size will be calculated after preliminary data analysis from the initial six months of data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomisation of surface finishing treatment per side (mesial or distal) of each zirconia crown will be made at the laboratory fabrication step, and the treatment codes will be known only by the certified technician and Projec PI. The clinician, who is also the investigator and outcomes assessor, will not assess the codes until the final data analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healing time of at least two months for patients who underwent extraction in areas to be rehabilitated with implants
- •Adequate bone volume at the implant site (ie, sufficient for placement of an implant of at least 3.3 mm in diameter and 6 mm in length) assessed by preoperative CT and clinical evaluation.
- •Use of Straumann bone level or conical bone level implants, with NC or RC platforms.
排除标准
- •Patients with systemic diseases (e.g., heart disease, leukocyte and coagulation disorders, metabolic disorders, immunosuppression)
- •History of radiotherapy in the head and neck region
- •Current treatment with steroids and/or bisphosphonates
- •Neurological or psychiatric impairment that can interfere with good oral hygiene
- •Smoking (more than 10 cigarettes a day)
- •History of illicit drug or alcohol abuse
结局指标
主要结局
Change from baseline Hygiene Index at six months
时间窗: from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Change from six-month Hygiene Index at one year
时间窗: from six months (T1) to one year (T2) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Change from baseline Index of Gingival Bleeding at six months
时间窗: from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
Change from six-month Index of Gingival Bleeding at one year
时间窗: from six months (T1) and one year (T2) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
Change from one-year Hygiene Index at two years
时间窗: from one year (T2) to two years (T3) of follow-up
Hygiene Index: will be visually evaluated the presence of bacterial plaque (biofilm) and the presence of visible inflammation
Change from one-year Index of Gingival Bleeding at two years
时间窗: from one year (T2) to two years (T3) of follow-up
Index of Gingival Bleeding: Gingival probe around the zirconia crown, as per the last consensus of Periodontics (Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions)
次要结局
- Change in baseline Overal Satisfaction at six months(from one week of installation of the PSI (T0 - baseline) to in six months (T1) of follow-up)
- Change in six-month Overal satisfaction at one year(from six months (T1) to one year (T2) of follow-up)
- Change in one-year Overal satisfaction at two years(from one year (T2) to two years (T3) of follow-up)
- Change in baseline Infrared thermography score at six months(from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up)
- Change in six-month Infrared thermography score at one year(from six months (T1) to one year (T2) of follow-up)
- Change in one-year Infrared thermography score at two years(from one year (T2) to two years (T3) of follow-up)
- Change in baseline Bone loss at six months(from one week of installation of the PSI (T0 - baseline) to six months (T1) of follow-up)
- Change in six-month Bone loss at one year(from six months (T1) to one year (T2) of follow-up)
- Change in one-year Bone loss at two years(from one year (T2) to two years (T3) of follow-up)