Prevention of complications arising from periodontal disease and improvement of oral health in pregnant periodontal patients, as well as in their babies. Oral Health
Conditions
Interventions
This is a randomized clinical trial to evaluate the impact of a preventive oral health program in 50 pregnant women with periodontal disease (intervention group) and 50 pregnant women with no interven
Sponsors
Universidad de Murcia
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Pregnancy status: At least 16 weeks of gestation. 2. Screening: Completed screening with all results within normal parameters. 3. Decision to continue the pregnancy: The patient has decided to continue the pregnancy. 4. Diagnosis of periodontal disease: Diagnosed with periodontal disease at stages (I, II, III, IV) and grades (A, B, C) according to Tonetti et al. (2018). 5. Pregnancy risk: Pregnancy is not classified as high risk. 6. Mental health: No significant mental disabilities that would prevent participation in the study or extreme communication difficulties. 7. Informed consent: Acceptance of the informed consent and voluntary participation in the study.
Exclusion criteria
Exclusion criteria: 1. Medical complications 2. Use of medications 3. Obstetric complications 4. History of psychiatric illness 5. Regular smokers or drinkers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathogenic oral microbiota in pregnant patients and their babies measured in subgingival microbiota samples collected using absorbent paper points inserted into deep periodontal pockets, guided by the CPITN scale (values 3-4) at three time points: during the first appointment (in the 2nd trimester of pregnancy), at the second appointment (end of the 3rd trimester) for all patients, and postpartum (4-5 months later). Additionally, samples of the baby's saliva and a cheek swab will be collected at the postpartum visit using the same absorbent paper points. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oral Health-Related Quality of Life measured using test OHIP-14 (Oral Health Impact Profile) at the first visit. 2. Dental Caries measured using the ICDAS Index (Assesses caries detection and severity visually) and CAOD Index (measures decayed, missing, and filled teeth) at the first visit. 3. Periodontal Health measured using the CPI Index (Community Periodontal Index) (Measures periodontal disease severity through probing depths), Silness and Loe bleeding index (based on the observation of bleeding from the gingival margin when gently probing the gums, and it helps to determine the level of gingival inflammation) and O'Leary Plaque Index (Assesses plaque accumulation visually) at the first visit. 4. Baby's Oral Health measured using the Caries Index in Babies: Assesses early dental caries in primary teeth at the visit postpartum. 5. Oral Hygiene Knowledge and Practices measured using Oral hygiene and dietary questionnaires on the first visit. 6. General Health and Sociodemographic Data measured using Medical history and sociodemographic questionnaire at the first visit and last visit postpartum. 7. Obstetric Complications Related to Oral Health measured using Medical history and obstetric follow-up at the first visit and last visit postpartum. 8. Postpartum Follow-Up and Baby's Oral Health measured using Postpartum oral health evaluation at visit postpartum. | — |
Countries
Spain
Contacts
Public ContactElena Sánchez-Guerrero Sánchez
Outcome results
None listed