Status:
UNKNOWN
Periodontitis and Adverse Pregnancy Outcomes in Metabolic Syndrome Patients- Interventional Study
Lead Sponsor:
Riyadh Colleges of Dentistry and Pharmacy
Conditions:
Low Birth Weight Baby
Metabolic Syndrome
Eligibility:
FEMALE
18-34 years
Phase:
NA
Brief Summary
Aim The Aim of the current study is to establish the association between periodontitis and adverse pregnancy outcomes in metabolic syndrome (Mets) patients and to evaluate the effect of intervention. ...
Detailed Description
Research Design/Methodology Ethics approval will be obtained from Institution Review Board of Riyadh Colleges of Dentistry and Pharmacy. Sample size calculation (Green, 1991) By considering the Green...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with Mets
- Primi gravida
- Singleton pregnancy \< 20 weeks gestation
- 18-34 years of age
- More than 20 teeth in the mouth
- Exclusion criteria:
- Previous history of abortion
- Assisted reproduction procedures like fertility medication or in vitro fertilization
- Positive history of HIV
- Positive history of genitourinary infections in previous 6 months
- Any medical contraindication to periodontal probing
- Undergone periodontal treatment or using chlorhexidine or other mouth rinses in the previous 6 months
- Rampant decay
- Taken systemic antibiotic or anti-inflammatory drugs in the last 6 months before the start of the study, or reported use of phenytoin, cyclosporine, calcium antagonists and/or hormone replacement therapy
- Alcoholics
- Smokers and ex-smokers
- History of kidney, liver or lung disease
- History of any other chronic or acute infections during the previous 6 months as assessed on clinical examination or routine lab testing
Exclusion
Key Trial Info
Start Date :
February 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03381469
Start Date
February 10 2018
End Date
December 1 2018
Last Update
February 13 2018
Active Locations (2)
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1
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, Saudi Arabia, 11681
2
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, Saudi Arabia, 11681