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

NCT06997757 | Not Yet Recruiting DMC

• 1 other identifier: shefaliperiopgids
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pregnancy Gingivitis

Keywords

mobile health

Outcome Measures

Primary Outcomes (3)

• Changes in the Plaque Index will be measured at baseline, 1 month follow up and at 3 month follow up.

  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

  3 months

• Changes in the Gingival Index will be measured at baseline, 1 month follow up and at 3 month follow up

  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

  3 months

• Changes in the Bleeding on Probing will be measured at baseline, 1 month follow up and at 3 month follow up

  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.

  3 months

Secondary Outcomes (1)

• Changes in the Probing Pocket Depth will be measured at baseline, 1 month and 3 month follow up

  3 months

Study Arms (2)

MOBILE HEALTH

EXPERIMENTAL

Patients will be given Phase I Therapy including Supragingival and Subgingival scaling along with chairside oral hygiene instructions and a mobile phone message reminder will be sent atleast twice a week

Behavioral: Mobile health; Procedure: Phase I Therapy

CONVENTIONAL THERAPY

ACTIVE COMPARATOR

Patients will be given Phase I Therapy including Supragingival and Subgingival Scaling along with chairside oral hygiene instructions

Procedure: Phase I Therapy

Interventions

Mobile health BEHAVIORAL

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

MOBILE HEALTH

Phase I Therapy PROCEDURE

Instructions for brushing twice daily and using interdental cleaning aids during appointment only.

CONVENTIONAL THERAPY; MOBILE HEALTH

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically Healthy pregnant women of age 18-35 years
• weeks of Gestation
• Generalized gingivitis (BOP score \>30%s, without attachment loss and radiographic bone loss, PPD≤3mm)
• Access to mobile phone
• At least 20 natural teeth present

You may not qualify if:

• Presence of systemic diseases that could influence the outcome of periodontal therapy (Diabetes mellitus, Hypertension)
• Smoking/alcohol consumption
• Patient currently on any antibiotic therapy
• Risk for Preterm Birth (Delivery \< 37 weeks of gestation)
• History of periodontal treatment in the last 6 months
• Physically and mentally impaired patients

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. Nishi Tanwar, MDS

  PGIDS , Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shefali Sharma, MDS

CONTACT

01262-297876; shefusharma16@gmail.com

Dr. Sanjay Tewari, MDS

CONTACT

principal.pgids@uhsr.ac.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 30, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): January 25, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)