Reducing Oral Health Disparities of Older Adults: Comparative Effectiveness of 2 Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 568
- 试验地点
- 2
- 主要终点
- Caries Arrest Rate
研究概览
简要总结
The study is a cluster randomized clinical trial (RCT) to be conducted in 40 (22 originally planned +16 additional) publicly subsidized housing facilities/sites (HUD Section 202) and other low-income housing voucher programs in NE Ohio. The facilities will be randomized to 2 arms: Arm 1 (20 sites) - Participants will receive biannual silver diamine fluoride (SDF) versus Arm 2 (20 sites): Participants will receive atraumatic restorative treatment (ART) with glass ionomer cement (GIC) + biannual fluoride varnish (FV) application. A total of 590 (550 originally planned + 40 additional) participants (Arm 1: 295, Arm 2: 295) will be followed for one year (baseline, 26 weeks, 52 weeks).
The protocol for each arm will address both coronal and root surface tooth decay lesions: Arm 1: The treatment will be bi-annual topical 38% SDF(Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL) following manufacturer's instructions and published guidelines; Arm 2: The treatment will be ART will be a modification where the cavity will be restored with high viscosity glass-ionomer cement (GIC) (GC Fuji Automix LC Resin Reinforced Glass Ionomer Restorative, Japan)). Patients will also receive biannual topical fluoride varnish treatments (FluoriMax, Elevate) according to manufacturer's instructions.
详细描述
Study Design:
A cluster randomized clinical trial (RCT) is planned in 40 (22 originally planned +16 additional) publicly subsidized housing facilities (HUD Section 202) and other low-income housing voucher programs in NE Ohio and will be randomized to 2 arms: Arm 1 (20 sites) - Participants will receive biannual SDF; Arm 2 (20 sites): Participants will receive ART + FV biannual application. All participants will be followed for one year and will receive a dental screening and prophylactic cleaning at all visits.
Study Population and Setting:
The long-term goal is to reduce disparities and improve oral health equity for low-income older adults. The immediate goal is to test interventions to address disparities. Therefore, the population/setting will be low socioeconomic status (SES) adults ≥ 62 years of age in 6 NE Ohio counties (Cuyahoga, Lorain, Summit, Ashtabula, Geauga, and Lake) residing in HUD Section 202 and other publicly subsidized housing facilities. Administrators have provided letters of support confirming the availability of sites and intent to participate. The population is diverse: African American/Black, Caucasian/White including Hispanic/Latino, and Asian. There are 64 HUD housing sites with 3,661 tenant units in the 6 counties. An additional 87 low-income facilities housing elderly are accounted for by regional housing authorities, adding 11,667 units. Therefore, a total of 151 facilities and 15,328 older adults are available.
The sample size goal of 40 (22+16) sites and 590 (550 originally planned + 40 additional) participants will be easily achieved. Medicaid participation among the tenants is 76% among facilities. From a prior study in these facilities it is expected that the mean age is 74 years, 76% female, 51% Caucasian, 45% African-American, 2% Hispanic, and 2% other racial/ethnic groups; 60% of HUD older adults had none/rare dental visits in over 3 years.
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
- Single (Participant)
盲法说明
We will attempt blinding of participants to the study group (participants). The hygienists (care providers) will be unaware of the treatment assignment when they go to their respective housing facilities. For all treatment visits, assessments will be conducted prior to the intervention delivery.
Two hygienists will go to the housing facility randomized to the SDF arm and the other two will go to the ART + FV arm. The baseline treatment to be applied will be revealed only after the baseline caries exam has been completed. At the 6 month follow-up visit, the two hygienists that applied SDF will now go to the facilities randomized to the ART + FV facilities and vice-versa to conduct the 6-month follow up caries assessment exam and treatment. We will follow similarly for the 12-moth follow-up visit. By this strategy, we will make sure that potential bias of the hygienist evaluating their own work is minimized.
入排标准
- 年龄范围
- 62 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study (1 year)
- •Male or female, aged 62 years or older
- •Live in a participating older adult housing facility to continue in the clinical trial phase of the study, an individual must:
- •Have at least one untreated active root or coronal carious lesion with ICDAS-II (2015) lesion severity code of 3 or greater
排除标准
- •Sensitivity to silver or other heavy-metal ions
- •Those with ulcerative gingivitis or stomatitis
- •Serious life-threatening medical disease
结局指标
主要结局
Caries Arrest Rate
时间窗: Baseline to 52 weeks
International Caries Detection and Assessment System was the standard used to identify active caries lesions by examination at baseline by calibrated dental hygienists. ICDAS examination was then used to assess caries arrest on permanent tooth surfaces with moderate to severe lesions (ICDAS codes 3-6 with activity code 2 (active)) that received SDF or ART + FV treatment baseline. A lesion was considered arrested if, at follow-up, the activity code is 1 (inactive) or the surface is sound (code S). The mean was calculated with standard deviation for both arms.
Tooth Pain
时间窗: Baseline to 52 weeks
Tooth Pain and Sensitivity were assessed using the PROMIS v.1.0 - Pain Intensity 3a (Modified for Dental). A mean pain intensity score was created for the 3-item scale and ranged from 0-4 (Had no pain - 0, Mild-1, Moderate-2, Severe-3 to Very Severe - 4) and was then collapsed to 0-2 (No pain-0, mild/moderate-1, and severe/very severe-2. Higher scores indicate more pain.
次要结局
- Prevention of New Decay(Baseline to 52 weeks)
- Oral Health Related Quality of Life(Baseline to 52 weeks)
研究者
Suchitra Nelson
Professor and Interim Chair, Department of Community Dentistry
Case Western Reserve University