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Enrolling by invitation NCT06594328

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

No phase Interventional Oral Health Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mHealth.
Who it may be relevant to
Registry conditions: Oral Health, Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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

Primary outcome measures

  • Oral Health Status [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Pakistan · 1 center
  • The University of Lahore Teaching Hospital — Lahore

Identifiers

NCT: NCT06594328 · UCD/ERCA/24/525

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗