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

NCT ID: NCT06594328

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-08-31

Brief Summary

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.

Conditions

Oral Health; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

mHealth

Intervention Type: BEHAVIORAL

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Saima Chaudhry

Director CHPL

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saima Chaudhry

Role: STUDY_CHAIR

University of Lahore

Locations

The University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

UCD/ERCA/24/525

Identifier Type: -

Identifier Source: org_study_id