"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
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
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||350 participants|
|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|
Pregnant with Periodontal Disease
- CAOD [ Time Frame: 9 months ]CAOD Index: 0: Absent or Great Destruction 1: Caries 2: Closed. It will be calculated: C + A + O.
- 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.
- 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.
- 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).
- 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).
- 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.
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
|Contact: María José Aguilar Cordero, Profesora||657841751 ext +firstname.lastname@example.org|
|Universidad de Granada||Recruiting|
|Granada, Spain, 18071|
|Study Director:||María José Aguilar Cordero, Profesora||Universidad de Granada|