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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277390
• Other study ID #: NDC/staff/2015-16/EC/2015
• Status: Completed
• Start date: August 1, 2015
• Est. completion date: November 10, 2019

Study information

• Verified date: February 2020
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: November 10, 2019
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• clinical 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

Locations

Country	Name	City	State
India	Swetha Tanneeru	Chennai	Tamil NADU

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

Country where clinical trial is conducted

India, 

References & 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. — View 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. — View 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-? 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.