Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 95 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

Periodontitis and Adverse Pregnancy Outcomes in Metabolic Syndrome Patients- Interventional Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03381469
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Ghousia Sayeed, Riyadh Colleges of Dentistry and Pharmacy

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.

Objectives

  1. To evaluate the changes in periodontal status of pregnant women with metabolic syndrome after non surgical periodontal therapy (NSPT)
  2. To evaluate the inflammatory marker levels in serum of pregnant women with metabolic syndrome after non surgical periodontal therapy
  3. To evaluate the effect of NSPT on adverse pregnancy outcomes of women with metabolic syndrome

Condition or disease Intervention/treatment Phase
Low Birth Weight Baby Metabolic Syndrome Pregnancy Complications Adverse Pregnancy Outcomes Periodontitis Premature Birth Procedure: Comprehensive periodontal treatment Procedure: single visit supragingival scaling Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three groups of patients will be examined parallel to each other
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Association Between Periodontitis and Adverse Pregnancy Outcomes in Metabolic Syndrome Patients- Interventional Study
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Periodontitis patients undergoing NSPT
Case group participants will receive comprehensive periodontal treatment also known as non-surgical periodontal therapy (NSPT) that will be completed by the end of week 20-21 of gestation.
Procedure: Comprehensive periodontal treatment
The Case group participants will receive non-surgical periodontal therapy that will be completed by the end of week 20-21 of gestation. This will consist of oral hygiene instruction with comprehensive periodontal treatment which will include excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth followed by supragingival and subgingival scaling and root planing (SRP) of sites with PDs > 4 mm and polishing of all the teeth. Participants will be offered treatment under local anesthetic when necessary. No limits will be imposed on the number of dental visits needed to accomplish periodontal therapy.
Other Name: Non Surgical Periodontal Therapy (NSPT)

Active Comparator: Periodontitis Patients undergoing supragingival scaling
The control group participants with periodontitis will receive oral hygiene instruction and single visit supragingival scaling of all teeth at their baseline visit.
Procedure: single visit supragingival scaling
The control and Placebo group participants will receive oral hygiene instruction and supragingival cleaning of all teeth at their baseline visit.

Active Comparator: Without Periodontitis undergoing supragingival scaling
Placebo group participants without periodontitis will receive oral hygiene instruction and single visit supragingival scaling of all teeth at their baseline visit.
Procedure: single visit supragingival scaling
The control and Placebo group participants will receive oral hygiene instruction and supragingival cleaning of all teeth at their baseline visit.




Primary Outcome Measures :
  1. Periodontal parameters- Change in Gingival Index [ Time Frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery ]
    Gingival index (GI). All teeth except third molars will be evaluated for gingival inflammation using a modification of the Loe and Silness , 1963 GI. The GI uses the following scores: 0 = normal gingiva; 1 = mild inflammation; 2 = moderate inflammation; and 3 = severe inflammation. Gingival index will be evaluated at four sites per tooth

  2. Periodontal parameters- Change in Plaque Index [ Time Frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery ]

    Plaque index (PI). Prebrushing plaque scores for the buccal surface of each tooth will be assigned using a zero to three scale (Silness and Loe, 1964 ) PI, with ''0''indicating an absence of plaque on the clinical crown and a ''3'' indicating the presence of soft deposits covering more than two-thirds of the crown.

    Plaque index will be evaluated at four sites per tooth


  3. Periodontal parameters-Change in Bleeding on probing [ Time Frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery ]
    Bleeding on probing will be evaluated at six sites per tooth

  4. Periodontal parameters- Change in Probing depth (PD) [ Time Frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery ]

    A manual periodontal probe UNC-15, Hu-Friedy, Chicago, IL ,will be used to record on all teeth present in the mouth. Probing depth will be calculated from gingival margin to base of pocket.

    Probing depth will be evaluated at six sites per tooth


  5. Periodontal parameters- Change in Clinical attachment level (CAL) [ Time Frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery ]

    A manual periodontal probe UNC-15, Hu-Friedy, Chicago, IL ,will be used to record on all teeth present in the mouth. CAL will be calculated using the clinically detectable cemento-enamel junction (CEJ) as reference and it will be measured from CEJ to base of pocket.

    Clinical attachment level will be evaluated at six sites per tooth



Secondary Outcome Measures :
  1. Serum bio markers -Change in Interleukin-6(IL-6) [ Time Frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery ]
    A 5-ml sample of peripheral venous blood will be collected by vein puncture. The blood samples will be centrifuged at 3000 g for 5 min and the serum will be separated. The serum samples will be frozen in plastic vials at -20ºC until further analyzing. Commercially available ELISA assays will be used to measure concentrations of IL-6 in blood samples, according to the manufacturer's recommendations.

  2. Serum bio markers -Change in Prostaglandin-E2 ( PG-E2) [ Time Frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery ]
    A 5-ml sample of peripheral venous blood will be collected by vein puncture. The blood samples will be centrifuged at 3000 g for 5 min and the serum will be separated. The serum samples will be frozen in plastic vials at -20ºC until further analyzing. Commercially available ELISA assays will be used to measure concentrations of PGE2 in blood samples, according to the manufacturer's recommendations.

  3. Pregnancy Outcomes -Preterm birth neonate [ Time Frame: • Within 1-2 days of delivery ]
    Preterm birth < 37 weeks neonate taken from patients record

  4. Pregnancy Outcomes -Low birth weight neonate [ Time Frame: • Within 1-2 days of delivery ]
    Low birth weight < 2500 gms neonate as taken from patients record



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female only
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381469


Contacts
Layout table for location contacts
Contact: Ghousia Sayeed, MDS 00955509731023 dr_ghousia@riyadh.edu.sa

Locations
Layout table for location information
Saudi Arabia
Riyadh Colleges of Dentistry and Pharmacy Recruiting
Riyadh, Saudi Arabia, 11681
Riyadh Colleges of Dentistry and Pharmacy Recruiting
Riyadh, Saudi Arabia, 11681
Contact: Hezakiah Mosadomi, PhD    00966112931177 ext 132    prof.mosadomi@riyadh.edu.sa   
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
Layout table for investigator information
Study Chair: Hezekiah Mosadomi, DMD Riyadh Colleges of Dentistry and Pharmacy

Publications:
Al Qahtani, Joseph B, Deepthi A, Vijayakumari B, Prevalence of chronic periodontitis and its risk determinants among female patients in the Aseer Region of KSA, Journal of Taibah University Medical Sciences .Volume 12, Issue 3, June 2017, Pages 241-248
International Diabetes Federation. Information on the IDF consensus worldwide definition of the metabolic syndrome. http://www.idf.org/webdata/docs/IDF_Meta_def_final.pdf Accessed 2014 Apr 10.
Sanz M, D'Aiuto F, Deanfield J, Fernandez-Avilés F. European workshop in periodontal health and cardiovascular disease-scientific evidence on the association between periodontal and cardiovascular diseases: A review of the literature. Eur Heart J Suppl 2010;12 Suppl B:B3-12

Layout table for additonal information
Responsible Party: Dr. Ghousia Sayeed, Assistant Professor, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT03381469     History of Changes
Other Study ID Numbers: MetS in Pregnancy
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Body Weight
Syndrome
Periodontitis
Birth Weight
Premature Birth
Pregnancy Complications
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications