Clinical trial NCT04277390: microRNA 155 Levels and Periodontal Microflora (Bacteria and Virus) in Preeclampsia.
Official title: Evidence Linking the Role of Viruses, Bacteria and Placental MIR155 in Chronic Periodontitis and Preeclampsia- A Genetic Microbiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Chronic Periodontitis
Keywords: periodontal microflora, preeclampsia
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 445
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Viruses, Bacteria and placental mir155 in Chronic Periodontitis and Preeclampsia
timeFrame: it took approximately 15 minutes to collect samples for DNA extraction.
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Swetha Tanneeru
state: Tamil NADU
Study officials:
affiliation: Meenakshi Ammal Dental College
name: Jaideep Mahendra, MDS, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.