Long-term Effectiveness of Zirconia Glaze Removal and Polish As an Adjunct to Non-surgical Therapy in Treatment of Persistent Peri-implant Mucositis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- mBI long term
研究概览
简要总结
This clinical trial is being conducted to study peri-implant mucositis (inflammation in the gums around dental implant that does not extend into the implant-supporting bone). There are currently no available treatment options able to provide long-term resolution of implant gum inflammation even with our current gold standard treatment of non-surgical cleanings and oral hygiene instructions. The purpose of the study is to compare the effect of crown glaze removal and subsequent polishing in addition to mechanical debridement compared to only mechanical debridement on the implant affected by implant gum inflammation.
In this study, participants will be randomized (put into a group by chance) into one of 2 study groups, groups A and B.
Group A: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician who will remove the glaze and polish the crown only in the areas that sit under the gums.
Group B: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician to perform a superficial cleaning only.
In both groups, the crown will be placed back on the implant and customized oral hygiene instructions will be provided.
The study will require four appointment. Appointment #1 is the screening appointment and will take 30-60 minutes. Appointment #2 is when treatment is delivered and will occur within 4 weeks of appointment #1. Appointment #3 is for the short-term follow-up and will occur within 60-70 days of appointment #2. Appointment #4 is for the long-term follow-up and will occur within 12-13 months of appointment #2. All these appointment will be in an outpatient setting at the institutional graduate periodontics clinic.
A total of 2 x-rays will be taken of the implant. One will be taken during appointment #1 to assess the bone around the implant. One will be taken during appointment #2 to ensure that the crown is fully seated when the crown is re-inserted.
The following information will be collected in appointment #1: gum measurements around the implants, how tight the implant contacts adjacent teeth, when the crown was delivered, previous cleanings around the implant, age, sex, gender, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values.
At appointments #2, 3, and 4, the following information will be collected: plaque around implant, gum measurements around implants, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values, gum fluid samples around the implant crown. In appointment #4, additionally, information on how the implant has been cleaned throughout the year will be collected.
详细描述
The study's objectives are:
- To determine whether a smooth crown surface (<0.2 μm Ra) can be established in-vitro after glaze removal and polishing based on adapted protocol from Go et al., 2019.
- To determine the effectiveness of submucosal non-surgical hand and powered instrumentation in removal of plaque and calculus.
- To assess the short- and long-term effectiveness of submucosal zirconia glaze removal and polishing as an adjunct to non-surgical therapy for treatment of persistent peri-implant mucositis. The null hypothesis is that the polishing protocol will not produce any significant differences in the resolution of inflammation compared to crown removal as part of the non-surgical debridement.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 1 single screw-retained zirconia glazed implant crown which is in function for at least 1 year, with adequate contact points, submucosal crown margins, no adjacent implants, adequate keratinized tissue (2mm or more), and peri-implant mucositis that persists despite recent (within the past 6 months) non-surgical debridement
排除标准
- •Contraindications to routine dental treatment Open interproximal contacts, splinted implant prosthesis, peri-implant health, peri-implantitis, cemented crown , removable implant prosthesis, recession past the implant platform Systemic antibiotic use within the last 2 weeks heavy smokers (more than 10 cigarettes/day) uncontrolled diabetes (HbA1C more than 7.0%)
结局指标
主要结局
mBI long term
时间窗: 12 months following treatment
modified Bleeding index (mBI) around the implant long term (12 months following treatment)
mBI short term
时间窗: 60-70 days following treatment
modified bleeding index (mBI) around the implant short term (60-70 days following treatment)
residual plaque and calculus
时间窗: baseline
% of plaque and calculus on the subgingival surface of crown
次要结局
- PI short term(60-70 days following treatment)
- PI long term(12 months following treatment)
- PD short term(60-70 days following treatment)
- PD long term(12 months following treatment)
- IL-1β baseline(baseline)
- IL-1β short-term(60-70 days following treatment)
- IL-1β long-term(12 months following treatment)
- INF-γ baseline(baseline)
- INF-γ short-term(60-70 days following treatment)
- INF-γ long-term(12 months following treatment)
- IL-2 baseline(baseline)
- IL-2 short-term(60-70 days following treatment)
- IL-2 long-term(12 months following treatment)
- IL-4 baseline(baseline)
- IL-4 short-term(60-70 days following treatment)
- IL-4 long-term(12 months following treatment)
- IL-6 baseline(baseline)
- Il-6 long-term(12 months following treatment)
- IL-8 baseline(baseline)
- IL-8 short-term(60-70 days following treatment)
- IL-8 long-term(12 months following treatment)
- IL-10 baseline(baseline)
- IL-10 short term(60-70 days following treatment)
- IL-10 long-term(12 months following treatment)
- TNF-α baseline(baseline)
- TNF-α short-term(60-70 days following treatment)
- TNF-α long-term(12 months following treatment)
- IL-6 short-term(60-70 days following treatment)
研究者
Chrysi Stavropoulou
Assistant professor
University of Manitoba