Pregnancy Related Clinical Trial
Official title:
The Effects of Pregnancy on Oral Health, Salivary ph and Flow Rate
Verified date | April 2024 |
Source | Mugla Sitki Koçman University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to evaluate the effects of pregnancy on salivary pH, flow rate, caries experience and periodontal status. The main questions it aims to answer are: - Does pregnancy affect caries experience and periodontal status? - Does pregnancy affect salivary pH and flow rate? - Is there a difference between pregnant and non-pregnant woman with respect to caries experience, periodontal status, salivary pH and flow rate? - Is there a difference among first, second and third trimester with respect to caries experience, periodontal status, salivary pH and flow rate?
Status | Completed |
Enrollment | 198 |
Est. completion date | April 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria for study arms - Volunteer participants - Pregnant women aged 18-35 years - Pregnant woman in different trimesters - Those who applied to Mugla Sitki Koçman University Faculty of Medicine Gynecology and Obstetrics Outpatient Clinic Inclusion Criteria for control arm - Volunteer participants - Non-pregnant women aged 18-35 years - Those who applied to Mugla Sitki Koçman University Faculty of Medicine Gynecology and Obstetrics Outpatient Clinic Exclusion Criteria: - Individuals with severe systemic disease - Individuals who used drugs that directly affect salivary flow rate (e.g., antihypertensive, diuretic, psychotherapeutic, and antiarthritic medications) - Individuals who used cigarettes or alcohol |
Country | Name | City | State |
---|---|---|---|
Turkey | Fatma Yilmaz | Mentese | Mugla |
Lead Sponsor | Collaborator |
---|---|
Mugla Sitki Koçman University |
Turkey,
Kamate WI, Vibhute NA, Baad RK. Estimation of DMFT, Salivary Streptococcus Mutans Count, Flow Rate, Ph, and Salivary Total Calcium Content in Pregnant and Non-Pregnant Women: A Prospective Study. J Clin Diagn Res. 2017 Apr;11(4):ZC147-ZC151. doi: 10.7860/JCDR/2017/24965.9516. Epub 2017 Apr 1. — View Citation
Kateeb E, Momany E. Dental caries experience and associated risk indicators among Palestinian pregnant women in the Jerusalem area: a cross-sectional study. BMC Oral Health. 2018 Oct 22;18(1):170. doi: 10.1186/s12903-018-0628-x. — View Citation
Laine M, Pienihakkinen K. Salivary buffer effect in relation to late pregnancy and postpartum. Acta Odontol Scand. 2000 Feb;58(1):8-10. doi: 10.1080/000163500429361. — View Citation
Laine M, Tenovuo J, Lehtonen OP, Ojanotko-Harri A, Vilja P, Tuohimaa P. Pregnancy-related changes in human whole saliva. Arch Oral Biol. 1988;33(12):913-7. doi: 10.1016/0003-9969(88)90022-2. — View Citation
Laine MA. Effect of pregnancy on periodontal and dental health. Acta Odontol Scand. 2002 Oct;60(5):257-64. doi: 10.1080/00016350260248210. — View Citation
Selwitz RH, Ismail AI, Pitts NB. Dental caries. Lancet. 2007 Jan 6;369(9555):51-9. doi: 10.1016/S0140-6736(07)60031-2. — View Citation
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available. — View Citation
Srinivas SK, Parry S. Periodontal disease and pregnancy outcomes: time to move on? J Womens Health (Larchmt). 2012 Feb;21(2):121-5. doi: 10.1089/jwh.2011.3023. Epub 2011 Oct 12. — View Citation
Wu M, Chen SW, Jiang SY. Relationship between gingival inflammation and pregnancy. Mediators Inflamm. 2015;2015:623427. doi: 10.1155/2015/623427. Epub 2015 Mar 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effects of pregnancy on caries experience | DMFT index was determined according to the sum of the number of decayed, missing and filled teeth according to WHO criteria. | Five minutes after the saliva sample was collected. | |
Primary | The effects of pregnancy on periodontal status. | The Community Periodontal Index (CPI) values used to determine periodontal health status were scored between 0 and 4 (0: health periodontal conditions; 1: gingival bleeding on probing; 2: calculus and bleeding; 3: periodontal pocket 4-5 mm; and 4: periodontal pocket =5.5 mm ) were determined. | Five minutes after the saliva sample was collected. | |
Primary | The effects of pregnancy on salivary pH. | To evaluate the salivary pH, the unstimulated saliva of the participants was collected. The pH analysis was performed using a calibrated benchtop pH meter (Hanna Instruments®, HI 2211, Woonsocket, RI, USA) within half an hour of sample collection to prevent degradation of the saliva. | Salivary pH measurements were made within half an hour at the latest after the saliva samples were taken. | |
Primary | The effects of pregnancy on salivary flow rate. | The salivary flow rate was determined by the weight measurement method using sensitive scales (Shimadzu, AW220, Japan). To determine the net saliva amount, the tare weight of the container tube was subtracted from the saliva-filled gross weight and divided by 5, and the flow rate per minute was determined in g/min or l/min considering the salivary density equal to 1 g/cm3 with an uncertainty of ± 0.001 rpm. (Flow Rate = Gross Weight-Tare Weight/5 min). | Saliva flow rate measurements were made within half an hour at the latest after the saliva samples were taken. |
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