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

Completed

• Conditions: Preeclampsia; Chronic Periodontitis
• Interventions: Other: clinical intervention for microbial analysis and MIR155 as biomarker

• Registration Number: NCT04277390
• Lead Sponsor: Meenakshi Ammal Dental College and Hospital

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.

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2018-08-20
• Study Completion: 2019-11-10
• Status Verified: 2020-02
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-20
• Last Update Submitted: 2020-02-22
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 445

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	clinical intervention for microbial analysis and MIR155 as biomarker	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.
Group A	clinical intervention for microbial analysis and MIR155 as biomarker	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.
Group B	clinical intervention for microbial analysis and MIR155 as biomarker	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.
Group C	clinical intervention for microbial analysis and MIR155 as biomarker	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.

Primary Outcome Measures

Name	Time	Method
Viruses, Bacteria and placental mir155 in Chronic Periodontitis and Preeclampsia	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.

Trial Locations

Locations (1)

Swetha Tanneeru; 🇮🇳 Chennai, Tamil NADU, India