跳至主要内容
临床试验/NCT06594328
NCT06594328Enrolling By Invitation不适用

Evaluating the Effect of Text Message Interventions in Maintaining Gingival Health in Pregnant Women: a Pragmatic Trial

University of Lahore1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

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

Experimental

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

No Intervention

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

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Saima Chaudhry

Director CHPL

University of Lahore

研究点 (1)

Loading locations...

相似试验