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Completed

NCT Number: NCT04277390

microRNA 155 Levels and Periodontal Microflora (Bacteria and Virus) in Preeclampsia.

Preeclamptic women with and without chronic periodontitis were recruited for the study. Subgingival plaque samples and placental tissue samples(postpartum) were obtained from the participants for the microbial analysis(bacteria, viruses) and MIR155 levels and comparison was done among groups. this study was designed in order to evaluate the role of periodontal microorganisms in preeclampsia and to find compare the MIR155 levels among participants, so as to check its importance as a biomarker for inflammatory disease like preeclampsia.

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Key information

About this study

Four hundred forty five pregnant women, aged 18-35 yrs were selected and were divided into four groups. Controls- 145 systemically and periodontally healthy, Group A-100 Systemically healthy women with chronic periodontitis, Group B- 100 Preeclamptic women with chronic periodontitis, Group C-100 Preeclamptic women without chronic periodontitis. Age, BMI, Socioeconomic status and periodontal parameters such as plaque index(PI), bleeding on probing(BOP), probing pocket dept(PPD), clinical attachment level(CAL) were recorded. Subgingival plaque and placental tissues (postpartum) were collected and assessed for periodontal pathogens such as Tannerella forsythia(Tf), Treponema denticola(Td), Porphyromonas gingivalis(Pg), Prevotella intermedia(Pi), Fusobacterium nucleatum(Fn). Herpes Simplex Virus(HSV), Ebstein Barr Virus(EBV), Human Cytomegalovirus(HCMV). microRNA155 levels were also assessed and compared between the groups.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women within the age group of 18-35 years with single gestation, having ≥ 20 natural teeth, who did not receive periodontal treatment in last six months and willing to participate in the study were included for the investigation.

Exclusion criteria

  • Pregnant women with current use of any form of tobacco, history of alcohol consumption and systemic medications were excluded from the study.

Treatment and study plan

clinical intervention for microbial analysis and MIR155 as biomarker

Other

Subgingival plaque was collected with sterile curette and placental tissue sample(postpartum with surgical blade with the help of gynecologist. all the samples were subjected to RTPCR for analysis of microorganisms likeTannerella forsythia(Tf), Treponema denticola(Td), Porphyromonas gingivalis(Pg), Prevotella intermedia(Pi), Fusobacterium nucleatum(Fn). Herpes Simplex Virus(HSV), Ebstein Barr Virus(EBV), Human Cytomegalovirus(HCMV). and MIR155 levels were also estimated

Primary outcomes

  1. Viruses, Bacteria and placental mir155 in Chronic Periodontitis and Preeclampsia

    Time frame: it took approximately 15 minutes to collect samples for DNA extraction.

    Viruses, Bacteria and placental mir155 were assessed in Chronic Periodontitis and Preeclamptic pregnant women.

Sponsors and collaborators

Lead sponsor

Meenakshi Ammal Dental College and Hospital

Other

Registry information

Official study title

Evidence Linking the Role of Viruses, Bacteria and Placental MIR155 in Chronic Periodontitis and Preeclampsia- A Genetic Microbiological Study

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Feb 20, 2020
Registry last updated
Feb 25, 2020

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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