Evaluating the Effect of Text Message Interventions in Maintaining Gingival Health in Pregnant Women: a Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oral Health Status
研究概览
简要总结
Gingivitis is a common condition, affecting more than 60% of pregnant women due to hormonal changes and inadequate plaque control. Left untreated, gingivitis can lead to more serious periodontal diseases and systemic inflammation, posing risks to overall health and reducing quality of life. Therefore, the study aims to assess the effectiveness of text messages in maintaining gingival health in pregnant women. The primary objective is to determine whether these reminders, which focus on proper brushing and flossing techniques, can reduce gingivitis and improve overall oral hygiene during pregnancy.
This research follows a two-group, parallel-arm, single-blind randomized control trial (RCT) design. The trial will be conducted at the Department of Gynecology and Obstetrics at the University of Lahore Teaching Hospital. Eligible participants are adult pregnant women showing signs of gingivitis, excluding those with bleeding disorders or moderate to severe pre-existing periodontal disease. Participants are randomly assigned to either a control group or an intervention group using computer-generated randomization.
Both groups will undergo oral health assessments at baseline, using the Plaque Index (PI), Gingival Index (GI), and Bleeding on Probing (BOP) measures to gauge plaque buildup and gingival inflammation. Follow-up assessments will be conducted at 4-6 weeks and 12-16 weeks. The intervention group will receive a weekly text message reminding them to practice proper oral hygiene, such as brushing and flossing. Both groups will also receive in-person demonstrations of oral hygiene techniques to ensure standardized knowledge on effective oral care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult pregnant female in 2nd trimester.
- •Access to a personal mobile phone.
- •Suffering from gingivitis (> 10% sites with bleeding on probing)
排除标准
- •Bleeding disorders.
- •Pre-existing moderate to severe periodontal disease.
研究组 & 干预措施
mHealth
participants of intervention group will receive text message reminder once a week on their mobile phones to brush and floss properly for the study duration
干预措施: mHealth (Behavioral)
Non mHealth
Participants of non-intervention group will not receive text message reminder once a week on their mobile phones to brush and floss properly for the study duration
结局指标
主要结局
Oral Health Status
时间窗: 1 year
Gingival index will be used to measure the oral health status of the mHealth and nonmHealth groups. The index is scored from 0-4. Once the scaling and root planning is done, half of the participants will be given mhealth message and half will not be given any message. After every three months the gingival index will be measured and compared to baseline (one achieved after treatment). The outcome is the maintenance of the gingival index at the same level post treatment or its improvement. Any deterioration will be considered a negative outcome.
次要结局
未报告次要终点
研究者
Saima Chaudhry
Director CHPL
University of Lahore
