Mobile Health on Improving Efficacy of Plaque Control in Antenatal Women With Gingivitis

NCT06997757 · tracked via the Priya Life Science India tracker

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Phase

Not applicable

Started

2025-06-25

Last updated

2025-05-30

Condition(s) studied

Pregnancy Gingivitis

Investigational drug(s) / intervention(s)

Mobile healthPhase I Therapy

Mobile health: Instructions for brushing twice daily and using interdental cleaning aids via regular mobile phone messages will be sent atleast twice a week.

Phase I Therapy: Instructions for brushing twice daily and using interdental cleaning aids during appointment only.

Study summary

Oral health education, behavioral therapy and counselling to improve home care in pregnant females along with periodontal therapy can be helpful in treating pregnancy associated gingivitis and pregnancy outcomes

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

35 Years

Healthy volunteers

Inclusion Criteria: 1. Systemically Healthy pregnant women of age 18-35 years 2. 8-24 weeks of Gestation 3. Generalized gingivitis (BOP score \>30%s, without attachment loss and radiographic bone loss, PPD≤3mm) 4. Access to mobile phone 5. At least 20 natural teeth present Exclusion Criteria: 1. Presence of systemic diseases that could influence the outcome of periodontal therapy (Diabetes mellitus, Hypertension) 2. Smoking/alcohol consumption 3. Patient currently on any antibiotic therapy 4. Risk for Preterm Birth (Delivery \< 37 weeks of gestation) 5. History of periodontal treatment in the last 6 months 6. Physically and mentally impaired patients

Primary outcome measure(s)

Changes in the Plaque Index will be measured at baseline, 1 month follow up and at 3 month follow up. — 3 months
Plaque Index as follows will be used for assessment of Plaque :- SCORE 0 : No Plaque SCORE 1: A film of plaque adhering to free gingival margin and adjacent area of the tooth recognized by running a probe SCORE 2 : Moderate accumulation of soft deposits within the gingival pockets or the tooth and gingival margin, which can be seen with naked eyes SCORE 3: Abundance of soft tissue matter on tooth surface and /or gingival margin
Changes in the Gingival Index will be measured at baseline, 1 month follow up and at 3 month follow up — 3 months
Gingival Index by as follows will be used to assess severity of gingival inflammation:- SCORE 0 : Absence of inflammation SCORE 1: Mild inflammation SCORE 2 : Moderate inflammation SCORE 3: Severe inflammation
Changes in the Bleeding on Probing will be measured at baseline, 1 month follow up and at 3 month follow up — 3 months
It will be measured by walking the periodontal probe at six sites of each tooth, it will be recorded as : 1- present , if it occurred within 15 seconds of probing 0- absent , if no bleeding occurred It will be calculated in %. After adding all the scores , total score will be divided by the total no. of surfaces assessed and multiplied by 100. It will be reported as % sites with bleeding on probing.

Trial sites (1)

Facility	City	Region	Status
PGIDS	Rohtak	Haryana