Effect of Text Message Interventions in Maintaining Gingival Health in Pregnant Women

University of Lahore

Status: Invitation-only

Conditions: Oral Health; Pregnancy

Treatments: Behavioral: mHealth

Study type: Interventional

Funder types: Other

Identifiers

NCT06594328

UCD/ERCA/24/525

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult pregnant female in 2nd trimester.
• Access to a personal mobile phone.
• Suffering from gingivitis (> 10% sites with bleeding on probing)

Exclusion criteria

• Bleeding disorders.
• Pre-existing moderate to severe periodontal disease.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

mHealth

Experimental group

Description:

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

Treatment:

Behavioral: mHealth

Non mHealth

No Intervention group

Description:

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