An interventional study of mHealth in Oral Health and Pregnancy, sponsored by University of Lahore. Status unknown at 1 site in Pakistan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Lahore · Not applicable, Interventional, and Prevention
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.
University of Lahore is the lead sponsor of 230 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
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
Behavioral: 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
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
Oral Health Status
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.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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