A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora

Periodontitis Clinical Trial

— OHSOGDMAOF  

Official title:

A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes (GDM) and Its Correlation With Oral Flora

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099574
• Other study ID #: 2022YJ080
• Secondary ID: Grant number: YC
• Status: Recruiting
• Start date: September 25, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: Fujian Medical University
• Contact: Rulin Liu, MSc student
• Phone: 17728062728
• Email: 601979085[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this observational study was to find out the oral status of pregnant women with GDM. The main questions it aims to answer are.

• What is the oral status of pregnant women with GDM

• Does GDM cause changes in the patient's oral flora Participants will describe the main tasks that participants will be asked to complete. The researcher will compare the [periodontal health group] to see if there is [different flora].

Description:

1. A self-administered general questionnaire, a semi-quantitative food frequency questionnaire, an oral health self-efficacy scale, an oral health literacy scale, and an oral health assessment scale were used for data collection to understand the current status of periodontitis in pregnant women with GDM, and to analyze the effects of demographic characteristics, dietary patterns, psychological factors and oral health-related knowledge on them; and biochemical indexes, such as fasting glucose, glycated hemoglobin, etc., and the outcome of pregnancy were collected in the late stage of pregnancy in pregnant women with GDM, so as to explore the effect of the current status of periodontitis in pregnant women with GDM on the outcome of their pregnancy.

2. Forty cases of GDM pregnant women in the periodontal health group and 40 cases in the periodontitis group were randomly selected, and the saliva specimens of GDM pregnant women in the periodontal health group and GDM pregnant women in the periodontitis group were collected. Saliva specimens from GDM pregnant women in the healthy group and GDM pregnant women in the periodontitis group were collected in the late pregnancy period, and the oral flora was detected by 16S rRNA high-throughput sequencing technology, so as to compare the differences in the distribution of oral flora between the two groups and to analyze the correlation between oral flora and periodontitis among GDM pregnant women. flora of GDM pregnant women and its correlation with periodontitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age = 18 years.

• 27-36 weeks of pregnancy

• receive a periodontal examination?

• no serious periodontal disease before pregnancy

• no communication problem

• no serious pregnancy complications and comorbidities.

Exclusion Criteria:

• history of oral antibiotics in the 3 months prior to the oral examination.

• cognitively impaired, unable to complete the questionnaire.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Oral Health
• Periodontitis

Intervention

Other:
• Periodontitis Group
The exposed group was the group of pregnant women with GDM suffering from periodontitis.

Locations

Country	Name	City	State
China	Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Li X, Zheng J, Ma X, Zhang B, Zhang J, Wang W, Sun C, Wang Y, Zheng J, Chen H, Tao J, Wang H, Zhang F, Wang J, Zhang H. The oral microbiome of pregnant women facilitates gestational diabetes discrimination. J Genet Genomics. 2021 Jan 20;48(1):32-39. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The self-administered general information questionnaire	Explore the factors influencing periodontitis in pregnant women with GDM.	2023.4-2023.12
Primary	The semi-quantitative food frequency questionnaire	Explore the factors influencing periodontitis in pregnant women with GDM.	2023.4-2023.12
Primary	The oral health self-efficacy scale	Explore the factors influencing periodontitis in pregnant women with GDM.	2023.4-2023.12
Primary	The oral health literacy scale	Explore the factors influencing periodontitis in pregnant women with GDM.	2023.4-2023.12
Primary	Characterization of the oral flora of pregnant women with GDM by 16sRNA high-throughput sequencing periodontitis	We collected saliva specimens from GDM pregnant women in the periodontal health group and GDM pregnant women in the periodontitis group and examined their oral flora by 16S rRNA high-throughput sequencing, compared the differences in the distribution characteristics of the oral flora between the two groups, and analyzed the correlation between the oral flora of GDM pregnant women and their periodontitis.	2023.4-2023.12
Secondary	The prevalence of periodontitis in pregnant women with GDM will be clarified by periodontal examination.	The periodontal status of all subjects will be assessed by a dentist. Periodontitis will be diagnosed based on the diagnostic criteria of the Centers for Disease Control and Prevention of the American Academy of Periodontology (CDC/AAP).	2023.4-2023.12

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