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"Periodontal Disease as a Possible Risk Factor for Complications During Pregnancy and Childbirth (PERIOEM)

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ClinicalTrials.gov Identifier: NCT03788473
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
María José Aguilar Cordero, Universidad de Granada

Brief Summary:

Pregnancy is a physiological state that is part of the reproductive life of women, establishing their fertile age between 15 and 45 years mainly. This stage will not only mark the birth of the baby but also cause various changes both immunological and physiological, to accommodate the growing fetus.

Maternal periodontitis has direct and indirect potential to influence the health of the fetus-maternal unit. According to the literature reviewed, the first evidence that oral bacteria influenced pregnancy outcomes was reported by Collins et al. The injection of P. gingivalis into pregnant hamsters caused intrauterine growth retardation and smaller fetuses, together with an increase in the levels of proinflammatory mediators (IL-1b and PGE2) in the amniotic fluid.

Two hypotheses have been pointed out regarding the link between oral health and the adverse outcome of pregnancy. The first states that periodontal disease causes abnormal systemic immune changes, leading to complications in pregnancy. While the second hypothesis suggests that oral bacteria directly colonize the placenta, causing localized inflammatory responses, resulting in prematurity and other adverse outcomes.


Condition or disease
Periodontitis During Pregnancy

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Months
Official Title: "Periodontal Disease as a Possible Risk Factor for Complications During Pregnancy and Childbirth
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : July 26, 2019
Estimated Study Completion Date : November 26, 2021

Group/Cohort
Control.
Healthy Pregnant
Case.
Pregnant with Periodontal Disease



Primary Outcome Measures :
  1. CAOD [ Time Frame: 9 months ]
    CAOD Index: 0: Absent or Great Destruction 1: Caries 2: Closed. It will be calculated: C + A + O.

  2. Bleeding on probing [ Time Frame: 9 months ]
    Ainamo and Bay index modified for bleeding on probing: when inserting the probe into the groove if: 0- does not bleed; 1-bleed It will be computed according to the following formula: number of bleeding points between the number of points examined per 100.

  3. Presence of plate [ Time Frame: 9 months ]
    Index of Silness and Löe: If when passing the probe: 0, there is no plate; 1, plate when passing the probe; 2, plate with the naked eye; 3, abundant plaque around the tooth even with tartar. It will be calculated by adding the values obtained for each tooth, among the number of teeth present.

  4. Periodontal insertion level [ Time Frame: 9 months ]
    Distance of the cementoenamel line to the bottom of the periodontal pocket (probing depth + recession, or probing depth - hyperplasia). It will be measured in 6 sites per tooth (mesial-vestibular, vestibular, disto-vestibular and palatal / lingual-distal, palatal / lingual, palatal / lingual-mesial).

  5. Depth of stock [ Time Frame: 9 months ]
    Distance from the gingival margin to the bottom of the periodontal pocket (junctional epithelium). It will be measured with a millimetric probe. It will be measured in 6 sites per tooth (mesial-vestibular, vestibular, disto-vestibular and palatal / lingual-distal, palatal / lingual, palatal / lingual-mesial).

  6. Periodontal disease [ Time Frame: 9 months ]
    Periodontitis was diagnosed when the loss of buccal epithelial attachment (vestibular-palatal) was greater than 3 mm and depth of the pouch greater than or equal to 3 mm in 2 teeth or more.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
Our research project "PERIOEM Study", is part of the BECOME framework project (Behavior of biomarkers (lipid profile and prolactin) during pregnancy and lactation through a biological multiparadigm model), whose main objective is to determine the evolution of the lipid profiles during pregnancy, to create a biological predictive model, which establishes thresholds above which, the increase of biomarkers constitutes a risk marker related to the development of diseases during pregnancy, childbirth and lactation. The BECOME study is registered in Clinical Trial NCT02811172; which obtained the suitability by the ethics committee on April 28, 2015.
Criteria

Inclusion Criteria:

  • Pregnant women over 12 weeks.
  • Pregnant women who consent to participate in the study by signing informed consent.

Exclusion Criteria:

  • Pregnant with less than 6 teeth.
  • Pregnant women who have been treated for Periodontal Disease in the last 6 months. -E Multiple branches.

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): NCT03788473


Contacts
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Contact: María José Aguilar Cordero, Profesora 657841751 ext +34 mariajaguilar@telefonica.net

Locations
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Spain
Universidad de Granada Recruiting
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Investigators
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Study Director: María José Aguilar Cordero, Profesora Universidad de Granada

Additional Information:

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Responsible Party: María José Aguilar Cordero, Doctor of science in Nursing, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03788473     History of Changes
Other Study ID Numbers: BECOME
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases