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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- 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
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
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.
- Conditions
- Pregnancy Gingivitis
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Phase I Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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.
- First posted30 May 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy GingivitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Nishi Tanwar, MDS, Principal investigator, PGIDS , Rohtak
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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health on Improving Efficacy of Plaque Control in Antenatal Women With Gingivitis : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06997757
- Acronym / sponsor ID
- shefaliperiopgids
- Conditions
- Pregnancy Gingivitis
- Keywords
- mobile health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOBILE HEALTH | Experimental | Behavioral: Mobile health, Procedure: Phase I TherapyPatients 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 |
| CONVENTIONAL THERAPY | Active comparator | Procedure: Phase I TherapyPatients will be given Phase I Therapy including Supragingival and Subgingival Scaling along with chairside oral hygiene instructions |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile healthInstructions for brushing twice daily and using interdental cleaning aids via regular mobile phone messages will be sent atleast twice a week. | Behavioural | MOBILE HEALTH |
| Phase I TherapyInstructions for brushing twice daily and using interdental cleaning aids during appointment only. | Procedure or surgery | CONVENTIONAL THERAPY, MOBILE HEALTH |
Primary outcome
Changes in the Plaque Index will be measured at baseline, 1 month follow up and at 3 month follow up.
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Changes in the Probing Pocket Depth will be measured at baseline, 1 month and 3 month follow up
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Recruiting
CHEER Oral Health in Pregnancy Study
Gingivitis, Dental Health
RecruitingPhase 2/3
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
Preterm Birth, Low Birthweight Neonate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Sanjay Tewari, MDS contact
Dr. Nishi Tanwar, MDS principal investigator
PGIDS , Rohtak
1 site in 1 country: see every site and its status.
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.