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

Dental Caries Clinical Trial

Official title:

Oral Health Status and Unexplained Female Infertility

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03575494
• Other study ID #: 40465587-177
• Status: Withdrawn
• Start date: April 15, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: October 2020
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2020
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Female Infertility
• Infertility
• Infertility, Female

Intervention

Other:
• Intraoral and Radiographic Dental Examination
(ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University	Rize

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Oral Health Status and Fertility Treatment