CClinicalTrials.gg
CompletedNCT04277390Updated Feb 25, 2020

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

An observational study in Preeclampsia and Chronic Periodontitis, sponsored by Meenakshi Ammal Dental College and Hospital. Completed at 1 site in India. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Meenakshi Ammal Dental College and Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
445
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Preeclampsia
  • Chronic Periodontitis

Keywords

  • periodontal microflora, preeclampsia
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 445 is above the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Meenakshi Ammal Dental College and Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Controls- 145 systemically and periodontally healthy pregnant women, Group A-100 Systemically healthy pregnant women with chronic periodontitis, Group B- 100 Preeclamptic pregnant women with chronic periodontitis, Group C-100 Preeclamptic pregnant women without chronic periodontitis.

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

Exclusion Criteria:

  • Pregnant women with current use of any form of tobacco, history of alcohol consumption and systemic medications were excluded from the study.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
445 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Controls

    145 systemically and periodontally healthy pregnant women Subgingival samples and placental tissue samples(postpartum) were collected for microbial analysis and check for the levels of MIR155.

    Other: clinical intervention for microbial analysis and MIR155 as biomarker

  • Group A

    Group A-100 Systemically healthy pregnant women with chronic periodontitis. Subgingival samples and placental tissue samples(postpartum) were collected for microbial analysis and check for the levels of MIR155.

    Other: clinical intervention for microbial analysis and MIR155 as biomarker

  • Group B

    Group B- 100 Preeclamptic pregnant women with chronic periodontitis. Subgingival samples and placental tissue samples(postpartum) were collected for microbial analysis and check for the levels of MIR155.

    Other: clinical intervention for microbial analysis and MIR155 as biomarker

  • Group C

    Group C-100 Preeclamptic pregnant women without chronic periodontitis. Subgingival samples and placental tissue samples(postpartum) were collected for microbial analysis and check for the levels of MIR155.

    Other: clinical intervention for microbial analysis and MIR155 as biomarker

Interventions

  • Otherclinical intervention for microbial analysis and MIR155 as biomarker

    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

06

What researchers measure

Primary outcomes

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

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

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

07

Study locations

1 site
  • Swetha Tanneeru
    Chennai, Tamil NADU 600095, India
08

References and documents

Publications

  • Barak S, Oettinger-Barak O, Machtei EE, Sprecher H, Ohel G. Evidence of periopathogenic microorganisms in placentas of women with preeclampsia. J Periodontol. 2007 Apr;78(4):670-6. doi: 10.1902/jop.2007.060362. PubMed 17397314 ↗
  • Jaiman G, Nayak PA, Sharma S, Nagpal K. Maternal periodontal disease and preeclampsia in Jaipur population. J Indian Soc Periodontol. 2018 Jan-Feb;22(1):50-54. doi: 10.4103/jisp.jisp_363_15. PubMed 29568173 ↗
  • Mahendra J, Parthiban PS, Mahendra L, Balakrishnan A, Shanmugam S, Junaid M, Romanos GE. Evidence Linking the Role of Placental Expressions of Peroxisome Proliferator-Activated Receptor-gamma and Nuclear Factor-Kappa B in the Pathogenesis of Preeclampsia Associated With Periodontitis. J Periodontol. 2016 Aug;87(8):962-70. doi: 10.1902/jop.2016.150677. Epub 2016 May 13. PubMed 27177289 ↗
  • Reddy BV, Tanneeru S, Chava VK. The effect of phase-I periodontal therapy on pregnancy outcome in chronic periodontitis patients. J Obstet Gynaecol. 2014 Jan;34(1):29-32. doi: 10.3109/01443615.2013.829029. PubMed 24359045 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04277390
Lead sponsor
Meenakshi Ammal Dental College and Hospital
Responsible party
Dr.Jaideep Mahendra (Professor, PhD guide, Director of Post Graduate Studies, Meenakshi Ammal Dental College and Hospital) — Principal investigator
First posted
Feb 20, 2020
Start date
Aug 1, 2015
Primary completion
Aug 20, 2018
Completion
Nov 10, 2019
Last update
Feb 25, 2020

Study contacts

Jaideep Mahendra, MDS, PhD
study director · Meenakshi Ammal Dental College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion