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

NCT ID: NCT04277390

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

445 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-01

Study Completion Date

2019-11-10

Brief Summary

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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

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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.

Conditions

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Preeclampsia Chronic Periodontitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

clinical intervention for microbial analysis and MIR155 as biomarker

Intervention Type 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

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.

clinical intervention for microbial analysis and MIR155 as biomarker

Intervention Type 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

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.

clinical intervention for microbial analysis and MIR155 as biomarker

Intervention Type 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

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.

clinical intervention for microbial analysis and MIR155 as biomarker

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meenakshi Ammal Dental College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Jaideep Mahendra

Professor, PhD guide, Director of Post Graduate Studies

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaideep Mahendra, MDS, PhD

Role: STUDY_DIRECTOR

Meenakshi Ammal Dental College

Locations

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Swetha Tanneeru

Chennai, Tamil Nadu, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 17397314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29568173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27177289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24359045 (View on PubMed)

Other Identifiers

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NDC/staff/2015-16/EC/2015

Identifier Type: -

Identifier Source: org_study_id

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