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NCT Number: NCT07787676

Periodontal Status and Thyroid Markers in Pregnancy

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.

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Key information

Conditions

Pregnancy Mouth Diseases Periodontal Disease Periodontal Diseases Stomatognathic Diseases Thyroid Disease Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location contact

Dr. ADITI SANGWAN, MDS

CONTACT

[email protected]

+919996002408

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Thyroxine (T4)

    Time frame: baseline

    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.

  2. Triiodothyronine (T3)

    Time frame: baseline

    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.

  3. Anti-Thyroid Peroxidase Antibody [Anti- TPO]

    Time frame: baseline

    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.

  4. High Sensitivity C-Reactive Protein (hsCRP)

    Time frame: baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

AKINSHA CHACKO, BDS

CONTACT

[email protected]

+919821278209

Dr. ADITI SANGWAN, MDS

CONTACT

[email protected]

+919996002408

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

Periodontal Status and Thyroid Markers in Pregnancy :A Cross- Sectional Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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