PregnancyNCT07787676
Periodontal Status and Thyroid Markers in Pregnancy
An observational study of Pregnancy and Thyroid Disease Pregnancy, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This cross-sectional study aims to evaluate the association between periodontal status and serum thyroid markers among 100 systemically healthy pregnant women aged 18-45 years in the second trimester (13-27 weeks). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Thyroid Disease Pregnancy, Periodontal Disease
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 3 Sep 2026to 30 Sep 2027
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will include systemically healthy females aged between 18- 45 years in second trimester of pregnancy attending out patient department of Department of Gynaecology, PGIMS, Rohtak for regular antenatal evaluation.
Who may be able to join
- Pregnant women aged 18-45 years
- Singleton pregnancy
- Gestational age between 13 and 27 weeks (second trimester)
- Presence of ≥20 natural teeth (excluding third molars)
- Willingness to participate in the study and provide written informed consent
- Attendance at the antenatal clinic during the study period
- Ability to undergo full-mouth periodontal examination
Who cannot join
- History of previously diagnosed thyroid disorders (diagnosed prior to pregnancy or currently)
- Current use of thyroid-related medication
- Presence of systemic diseases known to affect periodontal status or inflammatory response (e.g., diabetes mellitus, gestational diabetes mellitus, autoimmune diseases, cardiovascular disorders)
- Use of antibiotics, anti-inflammatory drugs, corticosteroids, or immunosuppressive agents within the previous 3 months
- Current or past tobacco use in any form (smoking or smokeless)
- Alcohol consumption during pregnancy
Show all 12Show fewer
- Multiple gestations (e.g., twin or higher-order pregnancy)
- History of periodontal therapy or professional dental cleaning within the last 6 months
- Presence of acute infections or inflammatory conditions at the time of examination
- Pregnancy-related complications such as gestational diabetes mellitus, preeclampsia, or threatened abortion
- Inability or unwillingness to comply with study procedures
- Presence of acute oral infections or inflammatory conditions at the time of examination (periapical abscess, acute pericoronitis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Dr. ADITI SANGWAN, MDS, +919996002408, draditidalal@gmail.com
About this study
Official title: Periodontal Status and Thyroid Markers in Pregnancy :A Cross- Sectional Study
This cross-sectional study aims to evaluate the association between periodontal status and serum thyroid markers among 100 systemically healthy pregnant women aged 18-45 years in the second trimester (13-27 weeks). Pregnancy is characterized by profound hormonal and immunological changes that influence both periodontal health and thyroid function. While periodontal inflammation has been associated with thyroid dysfunction in the general population, no study has explored this relationship during pregnancy. Participants will be recruited from the Department of Gynaecology, PGIMS, Rohtak, and undergo comprehensive periodontal examination, including periodontal inflamed surface area (PISA), probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque index (PI). Blood samples will be collected to assess thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), anti-thyroid peroxidase (Anti-TPO) antibodies, and high-sensitivity C-reactive protein (hsCRP). The primary objective is to determine the association between PISA and serum TSH levels, while secondary objectives include evaluating the relationship of periodontal parameters with T3, T4, Anti-TPO, hsCRP, and the distribution of thyroid profiles (euthyroid, hypothyroid, and hyperthyroid) according to periodontal status. Data will be analyzed using appropriate descriptive statistics, Pearson/Spearman correlation, and multiple linear regression after testing for normality. By investigating the interplay between periodontal inflammation and thyroid function during pregnancy, this study seeks to generate novel evidence that may support integrated periodontal and antenatal care strategies, ultimately contributing to improved maternal and fetal health outcomes.
- Conditions
- Pregnancy, Thyroid Disease Pregnancy, Periodontal Disease
- Medical subject headings
- Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid Stimulating hormone
evaluation of thyroid stimulating hormone (TSH) and its corelation with clinical periodontal parameters : bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment loss (CAL), plaque index (PI) and periodontal inflamed surface area (PISA) among pregnant women in second trimester.
Measured: baseline
Secondary outcomes (4)
Thyroxine (T4)
Correlation of Thyroxine (T4) with periodontal probing depth [PPD], clinical attachment loss [CAL], bleeding on probing [BOP] and plaque index [PI] ] among pregnant women in second trimester.
Measured: baseline
Triiodothyronine (T3)
Correlation of Triiodothyronine (T3) with periodontal probing depth [PPD], clinical attachment loss [CAL], bleeding on probing [BOP] and plaque index [PI] ] among pregnant women in second trimester.
Measured: baseline
Anti-Thyroid Peroxidase Antibody [Anti- TPO]
Correlation of Anti-Thyroid Peroxidase Antibody [Anti- TPO] with periodontal probing depth [PPD], clinical attachment loss [CAL], bleeding on probing [BOP] and plaque index [PI] ] among pregnant women in second trimester.
Measured: baseline
High Sensitivity C-Reactive Protein (hsCRP)
Correlation of High Sensitivity C-Reactive Protein (hsCRP) with periodontal probing depth [PPD], clinical attachment loss [CAL], bleeding on probing [BOP] and plaque index [PI] ] among pregnant women in second trimester.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start3 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787676
- Sponsor's protocol ID
- Akinsha Chacko Perio 26/60
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Status and Thyroid Markers in Pregnancy :A Cross- Sectional Study
- ClinicalTrials.gov ID
- NCT07787676
- Acronym / sponsor ID
- Akinsha Chacko Perio 26/60
- Conditions
- Pregnancy, Thyroid Disease Pregnancy, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Aug 2026 (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.
This cross-sectional study aims to evaluate the association between periodontal status and serum thyroid markers among 100 systemically healthy pregnant women aged 18-45 years in the second trimester (13-27 weeks). Pregnancy is characterized by profound hormonal and immunological changes that influence both periodontal health and thyroid function. While periodontal inflammation has been associated with thyroid dysfunction in the general population, no study has explored this relationship during pregnancy. Participants will be recruited from the Department of Gynaecology, PGIMS, Rohtak, and undergo comprehensive periodontal examination, including periodontal inflamed surface area (PISA), probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque index (PI). Blood samples will be collected to assess thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), anti-thyroid peroxidase (Anti-TPO) antibodies, and high-sensitivity C-reactive protein (hsCRP). The primary objective is to determine the association between PISA and serum TSH levels, while secondary objectives include evaluating the relationship of periodontal parameters with T3, T4, Anti-TPO, hsCRP, and the distribution of thyroid profiles (euthyroid, hypothyroid, and hyperthyroid) according to periodontal status. Data will be analyzed using appropriate descriptive statistics, Pearson/Spearman correlation, and multiple linear regression after testing for normality. By investigating the interplay between periodontal inflammation and thyroid function during pregnancy, this study seeks to generate novel evidence that may support integrated periodontal and antenatal care strategies, ultimately contributing to improved maternal and fetal health outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will include systemically healthy females aged between 18- 45 years in second trimester of pregnancy attending out patient department of Department of Gynaecology, PGIMS, Rohtak for regular antenatal evaluation.
Key inclusion criteria (7 listed)
- Pregnant women aged 18-45 years
- Singleton pregnancy
- Gestational age between 13 and 27 weeks (second trimester)
- Presence of ≥20 natural teeth (excluding third molars)
- Willingness to participate in the study and provide written informed consent
Key exclusion criteria (12 listed)
- History of previously diagnosed thyroid disorders (diagnosed prior to pregnancy or currently)
- Current use of thyroid-related medication
- Presence of systemic diseases known to affect periodontal status or inflammatory response (e.g., diabetes mellitus, gestational diabetes mellitus, autoimmune diseases, cardiovascular disorders)
- Use of antibiotics, anti-inflammatory drugs, corticosteroids, or immunosuppressive agents within the previous 3 months
- Current or past tobacco use in any form (smoking or smokeless)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thyroid Stimulating hormone
Time frame: baseline
evaluation of thyroid stimulating hormone (TSH) and its corelation with clinical periodontal parameters : bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment loss (CAL), plaque index (PI) and periodontal inflamed surface area (PISA) among pregnant women in second trimester.
4 secondary outcomes
Thyroxine (T4)
Time frame: baseline
Triiodothyronine (T3)
Time frame: baseline
Anti-Thyroid Peroxidase Antibody [Anti- TPO]
Time frame: baseline
High Sensitivity C-Reactive Protein (hsCRP)
Time frame: baseline
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 26 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Thyroid Disease Pregnancy, 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 7 inclusion and 12 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 26 Aug 2026. 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 AKINSHA CHACKO, BDS (+919821278209, akinshachacko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid Stimulating hormone (time frame: baseline). 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 26 Aug 2026.