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Proteins and salivary metabolites related to gum and bone disease around the teeth and Gestational Diabetes Mellitus during the 3rd trimester of pregnancy

Proteins and salivary metabolites related to Periodontitis and Gestational Diabetes Mellitus during the 3rd trimester of pregnancy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-653b457
Enrollment
Unknown
Registered
2024-06-05
Start date
2024-02-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational, Diabetes

Interventions

As this is an observational investigation, there is no intervention in this study. The objective of this study will be to evaluate the salivary proteomic and metabolomic profile related to Gestational
with GDM but without periodontitis (GDM-NP = 20)
without GDM but with periodontitis (N-P = 20)
no GDM and no periodontitis (N-NP = 20). Saliva samples will be collected and analyzed to investigate proteins and metabolites associated with GDM and periodontitis. Observational measures will be: gl
H01.158.273.180.599
H01.158.273.180.350.700

Sponsors

Faculdade de Odontologia de Bauru - Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia de Bauru - Universidade de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women who are in the 3rd trimester of pregnancy (from the 27th gestational week); between 18 and 40 years of age; with regular follow-up with the obstetrician; who have already undergone the Oral Glucose Tolerance Test through the Unified Health System between the 24th and 28th week of pregnancy, as recommended by the World Health Organization; and who present adequate cognitive and neuromotor behavior, enabling easy understanding for participation in the research and adequate ability to perform regular oral hygiene

Exclusion criteria

Exclusion criteria: Participants who have systemic arterial hypertension (blood pressure equals to or higher than 140/90 mmHg) diagnosed before or during pregnancy will be excluded from the sample; pre eclampsia; malnutrition (pre-pregnancy Body Mass Index [BMI] lower than 18.50 kg/m2); obesity (pre-pregnancy BMI equals to or higher than 30.00 kg/m2); diagnosed or suspected of being infected with SARS-CoV-2; who require absolute rest for any medical reason; diagnosed with any other systemic disease other than Gestational Diabetes Mellitus; who are using, or who have used at any time during pregnancy, antibiotics or any medication that may interfere with periodontal condition and/or salivary flow (for example, immunosuppressive drugs, anticonvulsants or calcium channel blockers, such as cyclosporine, phenytoin or nifedipine, respectively), with hyposalivation (flow lower than 0.25 ml/min); diagnosed with stage I periodontitis; who have one or more cavitated carious lesions; with multiple tooth loss (more than two teeth per hemiarch); with tooth loss prior to pregnancy due to periodontitis; who are undergoing orthodontic, periodontal treatment or with another dental surgeon with a treatment plan already determined; who have previously undergone surgical periodontal treatment; users of alcohol/tobacco/illegal drugs during pregnancy

Design outcomes

Primary

MeasureTime frame
To identify proteins differentially expressed in saliva and deregulation in the levels of salivary metabolites of pregnant women with Gestational Diabetes Mellitus and periodontitis, determined through mass spectrometry and Nuclear Magnetic Resonance spectroscopy, respectively

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactGerson Foratori Junior

Faculdade de Odontologia de Bauru - Universidade de São Paulo

gerson.foratori@usp.br+55-14-32358271

Outcome results

None listed

Source: REBEC (via WHO ICTRP)