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

NCT06594328 | Enrolling By Invitation DMC

• 1 other identifier: UCD/ERCA/24/525
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

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

Behavioral: mHealth

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

Interventions

mHealth 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

mHealth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Saima Chaudhry

  University of Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director CHPL

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: August 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)