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Pregnancy GingivitisNCT06997757

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

A study testing Mobile health and Phase I Therapy in people with Pregnancy Gingivitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Pregnancy Gingivitis
What is being tested?
Mobile health and Phase I Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteIndia
Study dates
25 Jun 2025to 25 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Systemically Healthy pregnant women of age 18-35 years
  • 8-24 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Sanjay Tewari, MDS contact

principal.pgids@uhsr.ac.in

India1 site
  • PGIDS

    Rohtak, Haryana, 124001

    Shefali Sharma, MDS, 9717302890 ext. 91, shefusharma16@gmail.com

    Dr. Sanjay Tewari, MDS, 01262-297876, principal.pgids@uhsr.ac.in

Other trials in India

About this study

Official title: Mobile Health on Improving Efficacy of Plaque Control in Antenatal Women With Gingivitis : A Randomized Controlled Clinical Trial

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

Read the detailed description

Pregnancy gingivitis has been extensively documented in the previous literature with prevalence of 36-100%. It has been reported that gingivitis is clinically seen in all the pregnant women with increase in gingival changes from 2nd to 8th month of gestation and decreasing in 9th month and post childbirth. The heightened inflammatory response of gingiva towards local irritants is believed to be responsible for the pregnancy gingivitis and has been correlated with the dose-dependent influence of female sex hormones during pregnancy. It has been suggested the increased levels of progesterone exert changes in the microvascular system of gingiva which may aggravate gingivitis. Change in the hormonal level during pregnancy have been found to be predisposing a factor for periodontal changes while Plaque acts as a precipitating factor for pathologic changes.All individuals develop gingivitis in absence of all oral hygiene measures and in healthy individuals a meticulous regime of daily plaque removal can prevent and cure the gingivitis. Since gingivitis is reversible there is a common misconception that a prolonged state of gingival inflammation during pregnancy causes no harm. It causes patient discomfort while brushing and its severity continues to increase during pregnancy. The potential for bacteremia and increased levels of pro-inflammatory cytokines may make effective treatment of gingivitis during pregnancy important for overall maternal and fetal health. In women having pregnancy associated gingivitis, who received periodontal therapy before 28weeks of gestation reported less incidence of Pre-term Labour and Low Birth Weight as compared to women who didn't receive any therapy. Therefore, oral health education, behavioural and counselling to improve home care in pregnant females along with periodontal therapy can be helpful in treating pregnancy associated gingivitis and pregnancy outcomes. Mobile Health is defined by WHO as "a term used for medical and publication health practice supported by mobile devices, such as mobile phones, patient monitoring devices, Personal Digital Assistants (PDAs), and other wireless devices." India has 1.15 billion mobile phone subscribers with 625 million urban \& 524 million rural subscribers. India also has the second highest mobile phone connectivity in the world which makes the use of Mobile health in healthcare ideal. Mobile Health can be an effective and valuable treatment as it offers real-time communication between patient and doctor. Mobile health has shown promising results in the medical field Mobile health applications have been found to be an effective adjunctive intervention in self -management by patients with type 2 diabetes. Use of mHealth as an adjunct component in managing gingivitis and in improving daily self-performed oral hygiene has been documented in previous literature.

Research shows that regular prompts and reminders effectively promote and reinforce healthy habits. The average time to form a habit is 66 days with the range of (18- 254days). Improvement in performing oral hygiene has been seen in periodontal patients due to repetition and reinforcement of oral hygiene instructions. It has been documented that text messages are effective in promoting behavioural changes in chronic diseases. Text messages play a key role in encouraging behavioural change and improving health knowledge by offering guidance, warnings, reminders, positive reinforcement and feedback.

Text messaging has been proven in the prevention and management of weight loss, smoking cessation and diabetes. Study has reported higher satisfaction levels among pregnant women who received text messages about prenatal care than those who only received standard prenatal care.

So, in the view of current literature we hypothesise that mobile health reinforcements can contribute to improve oral hygiene behaviours in antenatal women with gingivitis which may have long term benefits postnatally and can improve the pregnancy outcomes. To the best of our knowledge, no study till date has been conducted assessing the effectiveness of Mobile Health in pregnant women diagnosed with gingivitis in improving their oral hygiene after nonsurgical periodontal therapy. So this Randomised controlled Clinical Trial aims to clinically evaluate the effectiveness of Mobile Health in antenatal women with gingivitis in improving efficacy of Plaque control after non surgical periodontal therapy.

Being tested
Mobile health, Phase I Therapy
Keywords
mobile health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile healthBehavioural

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

  • Phase I TherapyProcedure or surgery

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

Study groups in NCT06997757
Study groupRoleWhat they receive
MOBILE HEALTHExperimentalPatients 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
Receives: Behavioral: Mobile health; Procedure: Phase I Therapy
CONVENTIONAL THERAPYActive comparatorPatients will be given Phase I Therapy including Supragingival and Subgingival Scaling along with chairside oral hygiene instructions
Receives: Procedure: Phase I Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months

  2. 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

    Measured: 3 months

  3. 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.

    Measured: 3 months

Secondary outcomes (1)
  1. Changes in the Probing Pocket Depth will be measured at baseline, 1 month and 3 month follow up

    Probing Pocket Depth will be measured as the distance from gingival margin to the base of the pocket .The Probing Depth measurements will be assessed using the periodontal probe. Measurements will be rounded to the nearest whole millimeter.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2025
  2. Study start25 Jun 2025 (estimated)
  3. Primary completion25 Jun 2026 (estimated)
  4. Study completion25 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997757
Sponsor's protocol ID
shefaliperiopgids
Status last verified
May 2025
First submitted
13 May 2025
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mobile health and Phase I Therapy in people with Pregnancy Gingivitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shefali Sharma, MDS (01262-297876 ext. 91, shefusharma16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Plaque Index will be measured at baseline, 1 month follow up and at 3 month follow up. (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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