Relationship Between Oral Health Status and Unexplained Female Infertility in Turkish Population

Oral Health Status and Unexplained Female Infertility

Periodontal diseases and dental caries are initiated by a pathogenic biofilm, in a susceptible host, affecting the tooth periodontium and hard tissues. Its possible association with many biologic systems has been studied. In this study, researchers investigated association between oral health and female infertility, and what is the biological rationale for such relationship.

Study Overview

• Status: Withdrawn
• Conditions: Dental Caries; Female Infertility
• Intervention / Treatment: Other: Intraoral and Radiographic Dental Examination

Detailed Description

Power analysis was performed with the G-Power software package to determine sample size.

To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. In dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II).

To analyze the correlation between oral health status and female infertility linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

• Study Type: Observational

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53000
    • Recep Tayyip Erdoğan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients were aged from 18 to 35 years, 100 females

Description

Inclusion Criteria:

• Women who had regular menses and can't conceive despite a long-term regular sexual intercourse for more than 12 months
• Women with normal hormone values and uterine cavity with at least one healthy fallopian tube.
• All male partners have a semen specimen with minimum 5 million motile sperm in the ejaculate.
• The control group members have minimum two normal pregnancies

Exclusion Criteria:

• Patients who have history of f; hydrosalpinx, polycystic ovarian syndrome, endometriosis grade 3-4, thyroid disease, tubal surgery, hyperprolactinemia, autoimmune diseases, diabetes mellitus, uterine/cervical anomalies, active liver disease, cardiovascular disease, premature ovarian failure, smoking and alcohol consumption, poor socioeconomic level, HIV-infected, obesity (body mass index ≥ 30 kg/m2), chronic upper respiratory tract diseases and dental fluorosis.
• Patients using fluoride supplements and orthodontic appliances

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
female infertility; Women who had regular menses and can't conceive despite a long-term regular sexual intercourse for more than 12 months	Other: Intraoral and Radiographic Dental Examination; (ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).
healthy; healthy patients who had minimum two normal pregnancies	Other: Intraoral and Radiographic Dental Examination; (ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
female infertility	Women with normal hormone values and uterine cavity with at least one healthy fallopian tube. All male partners have a semen specimen with minimum 5 million motile sperm in the ejaculate.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dental examination	All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II). The chosen sites were recorded as: 0 = sound; = first visible sign of noncavitated lesion seen only when the tooth is dried;; = visible noncavitated lesion seen when wet and dry;; = microcavitation in enamel;; = noncavitated lesion extending into dentine seen as an undermining shadow;; = small cavitated lesion with visible dentine: less than 50% of surface;; = large cavitated lesions with visible dentine in more than 50% of the surface. A single calibrated examiner measured probing depth-PD, clinical attachment level- CAL, plaque (Pl), and gingival indices (GI), bleeding on probing (BOP) at four sites per tooth using a manual periodontal probe (PCPUNC, Hu-Friedy, Chicago, IL, USA).	1 Day

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Publications and helpful links

General Publications

• Khanna SS, Dhaimade PA, Malhotra S. Oral Health Status and Fertility Treatment Including IVF. J Obstet Gynaecol India. 2017 Dec;67(6):400-404. doi: 10.1007/s13224-017-1025-0. Epub 2017 Jun 20.

Helpful Links

• Oral Health Status and Fertility Treatment

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 15, 2018
• Primary Completion (ANTICIPATED): April 15, 2019
• Study Completion (ANTICIPATED): February 15, 2020

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (ACTUAL): July 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Infertility; Dental Caries; Infertility, Female
• Other Study ID Numbers: 40465587-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available within 6 months of study finishing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No