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WithdrawnNCT03575494Updated Oct 8, 2020

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

An observational study in Dental Caries and Female Infertility, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Withdrawn at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational

Why this study was withdrawn
this study does not need to get a clinicaltrials number
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
0
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Caries
  • Female Infertility
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

Browse Dental Caries studies →

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients were aged from 18 to 35 years, 100 females

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • healthy

    healthy patients who had minimum two normal pregnancies

    Other: Intraoral and Radiographic Dental Examination

Interventions

  • OtherIntraoral and Radiographic Dental Examination

    (ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. dental examination

    All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II). The chosen sites were recorded as: 0 = sound; 1. = first visible sign of noncavitated lesion seen only when the tooth is dried; 2. = visible noncavitated lesion seen when wet and dry; 3. = microcavitation in enamel; 4. = noncavitated lesion extending into dentine seen as an undermining shadow; 5. = small cavitated lesion with visible dentine: less than 50% of surface; 6. = 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).

    Time frame: 1 Day

07

Study locations

1 site
  • Recep Tayyip Erdogan University
    Rize, 53000, Turkey
08

References and documents

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. PubMed 29162952 ↗

Individual participant data

Plan to share: No — Data will be available within 6 months of study finishing

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03575494
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
Gul Yildiz Telatar (Recep Tayyip Erdogan University Faculty of Dentistry, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Jul 2, 2018
Start date
Apr 15, 2018 (estimated)
Primary completion
Apr 15, 2019 (estimated)
Completion
Feb 15, 2020 (estimated)
Last update
Oct 8, 2020

Study contacts

Gül Yıldız Telatar
principal investigator · Recep Tayyip Erdogan University Dentistry Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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