Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Gingival index
研究概览
简要总结
The objective is a 3-year follow-up clinical trial to evaluate longitudinal indicators of periodontal disease (plaque score, bleeding on probing (BOP), and gingival index (GI)) in 58 participants who completed NCT03571958. These participants were randomized to a brief motivational (BMI) test group or a traditional oral hygiene instruction (OHI) group for a 1-year clinical trial from 2018-2020.
In addition, analysis of retrospective data to determine health topics that emerge from the behavior change strategy of BMI compared to traditional OHI by transcription of audio recordings from 2018-2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (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
- •° Completed all study visits of STUDY00003697 (NCT03571958)
排除标准
- •Current smoker or quit smoking within the last year
- •Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
- •Uncontrolled diabetes (HbA1C > 7)
- •Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS)
- •Current use of oral bisphosphonates
- •History of IV bisphosphonates
- •Require pre-medication or on long-term antibiotics
- •Current orthodontic treatment or planning to begin orthodontic treatment during the study
- •Unable to comply with the study protocol
结局指标
主要结局
Gingival index
时间窗: Recorded one time 2 years +/- 8 months
0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)
Plaque score
时间窗: Recorded one time 2 years +/- 8 months
Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%
Bleeding on probing
时间窗: Recorded one time 2 years +/- 8 months
Presence of bleeding (yes) or absent of bleeding (no)
次要结局
未报告次要终点
研究者
Michelle Arnett
Assistant Professor
University of Minnesota