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

NCT04277390 | Completed DMC

• 1 other identifier: NDC/staff/2015-16/EC/2015
• Study Type: observational
• Target: 445
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Chronic Periodontitis

Keywords

periodontal microflora, preeclampsia

Outcome Measures

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.

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

Study Arms (4)

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

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

Controls; Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Study Sites (1)

Swetha Tanneeru

Chennai, Tamil Nadu, 600095, India

Location

Related Publications (4)

• 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.

  PMID: 17397314 BACKGROUND

• 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.

  PMID: 29568173 BACKGROUND

• 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.

  PMID: 27177289 BACKGROUND

• 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.

  PMID: 24359045 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

subgingival plaque samples and placental tissue samples were obtained. DNA was isolated and then subjected to RTPCR for microbial identification and estimation of MIR155 levels.

MeSH Terms

Conditions

Pre-Eclampsia; Chronic Periodontitis

Interventions

imidazole mustard; Biomarkers

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Jaideep Mahendra, MDS, PhD

  Meenakshi Ammal Dental College

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD guide, Director of Post Graduate Studies

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 20, 2020
• Study Start: August 1, 2015
• Primary Completion: August 20, 2018
• Study Completion: November 10, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)