Oral health related quality of life among patients receiving non-surgical periodontal therapy by hand and ultrasonic instruments delivered by different modes: a randomized clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Difference in Oral Impact on Daily Performance (OIDP) score between baseline (T1) and third month (T2).
研究概览
简要总结
This study is a randomized clinical trial to assess the oral health related quality of life in patients undergoing non-surgical periodontal therapy by hand and ultrasonic scaler instruments which will be delivered by different modes, being carried out at Department of Periodontics, Government Dental College, Kottayam, Kerala. The selected study subjects who will give their willingness to participate, will be randomly assigned to any one of the five groups by sequentially numbered sealed opaque envelopes.
Periodontal charting will be done before the initiation of treatment along with their response to a questionnaire consisting of eight items to rate the impact of their oral health on their quality of life. The participants will be re-examined after 3 months and the same data will be recorded. Quantitative variables will be summarized into mean and standard deviation and significance of difference between the groups will be tested using one way ANOVA test. Intra-group difference at pre-treatment and post-treatment for oral health related quality of life will be compared using paired t-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with stage II and III periodontitis based on 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions.
- •Presence of more than or equal to sixteen permanent teeth in the mouth with at least one permanene molar an one incisor teeth in each quadrant.
- •Subjects with good general health.
- •No periodontal treatment done in the last six months.
排除标准
- •Antibiotics or analgesics usage three months before or its need during the study period.
- •Pregnant and lactating mothers.
- •Presence of acute periodontal infections.
- •Usage of any medications affecting neural or motor systems.
结局指标
主要结局
Difference in Oral Impact on Daily Performance (OIDP) score between baseline (T1) and third month (T2).
时间窗: Three months
次要结局
- Difference in Periodontal Inflamed Surface Area (PISA) value between baseline (T1) & third month (T2).(Three months)
研究者
Dr. Tony Kurien. J
Government Dental College, Kottayam