The Effects of Pregnancy on Oral Health

NCT06343337 | Completed

• 1 other identifier: MSKUDİSCLİNİCALTRİALS_FYİLMAZ.
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Pregnancy Related; Dental Caries; Periodontal Diseases; Saliva Altered

Keywords

CPI; DMFT; Unsitumulated saliva; Pregnant woman

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

First trimester

EXPERIMENTAL

Diagnostic Test: Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman

Second trimester

EXPERIMENTAL

Diagnostic Test: Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman

Third Trimester

EXPERIMENTAL

Diagnostic Test: Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman

Non-pregnant woman

OTHER

Control group

Diagnostic Test: Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman

Interventions

Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman DIAGNOSTIC_TEST

Total 198 volunteer (51 women for control, 47 women for 1st trimester, 51 women for 2nd trimester, and 49 women for 3rd trimester) were included. The data about sociodemographic characteristics, dental and systemic health conditions were recorded. Unsitumulated saliva samples were collected for 5 minutes by spitting method. The pH of saliva was measured by a portable pHmeter. The salivary flow rate was determined by the weight measurement method. DMFT index and CPI scores were determined. The statistical differences were evaluated by Kruskal-Wallis, Mann Whitney U and Chi Square tests (α=.05).

First trimester; Non-pregnant woman; Second trimester; Third Trimester

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant and non-pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer participants
• Pregnant women aged 18-35 years
• Pregnant woman in different trimesters
• Those who applied to Muğla Sıtkı Koçman University Faculty of Medicine Gynecology and Obstetrics Outpatient Clinic
• Volunteer participants
• Non-pregnant women aged 18-35 years
• Those who applied to Muğla Sıtkı Koçman University Faculty of Medicine Gynecology and Obstetrics Outpatient Clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Fatma Yilmaz

Menteşe, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 14158464 BACKGROUND

• 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.

  PMID: 30348139 BACKGROUND

• 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.

  PMID: 28571283 BACKGROUND

• 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.

  PMID: 21992584 BACKGROUND

• 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.

  PMID: 25873767 BACKGROUND

• Laine MA. Effect of pregnancy on periodontal and dental health. Acta Odontol Scand. 2002 Oct;60(5):257-64. doi: 10.1080/00016350260248210.

  PMID: 12418714 BACKGROUND

• Selwitz RH, Ismail AI, Pitts NB. Dental caries. Lancet. 2007 Jan 6;369(9555):51-9. doi: 10.1016/S0140-6736(07)60031-2.

  PMID: 17208642 BACKGROUND

• 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.

  PMID: 3256298 BACKGROUND

• 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.

  PMID: 10809393 BACKGROUND

• Yilmaz F, Carti Dorterler O, Eren Halici S, Kasap B, Demirbas A. The effects of pregnancy on oral health, salivary ph and flow rate. BMC Oral Health. 2024 Oct 25;24(1):1286. doi: 10.1186/s12903-024-05057-0.

  PMID: 39455976 DERIVED

MeSH Terms

Conditions

Dental Caries; Periodontal Diseases

Interventions

Gravidity

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Pregnancy; Reproduction; Reproductive History; Epidemiologic Factors; Public Health; Environment and Public Health

Study Officials

• FATMA YILMAZ, Asistant Professor

  Muğla Sıtkı Koçman Universty

  STUDY CHAIR

• Ozgul Carti Dorterler, Asistant Professor

  Muğla Sıtkı Koçman Universty

  PRINCIPAL INVESTIGATOR

• Saniye Eren Halici, Asistant Professor

  Muğla Sıtkı Koçman Universty

  PRINCIPAL INVESTIGATOR

• Burcu Kasap, Professor

  Muğla Sıtkı Koçman Universty

  PRINCIPAL INVESTIGATOR

• Aysegul Demirbas, Professor

  Ege Universty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual who evaluates the salivary pH and flow rate.
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: April 2, 2024
• Study Start: May 20, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)