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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575494
Recruitment Status : Withdrawn (this study does not need to get a clinicaltrials number)
First Posted : July 2, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital

Brief 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.

Condition or disease Intervention/treatment
Dental Caries Female Infertility 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Oral Health Status and Unexplained Female Infertility
Estimated Study Start Date : April 15, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : February 15, 2020

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. female infertility [ Time Frame: 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.



Secondary Outcome Measures :
  1. dental examination [ Time Frame: 1 Day ]

    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).



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients were aged from 18 to 35 years, 100 females
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575494


Locations
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Turkey
Recep Tayyip Erdogan University
Rize, Turkey, 53000
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Investigators
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Principal Investigator: Gül Yıldız Telatar Recep Tayyip Erdogan University Dentistry Faculty
Additional Information:
Publications:
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Responsible Party: Gul Yildiz Telatar, Recep Tayyip Erdogan University Faculty of Dentistry, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03575494    
Other Study ID Numbers: 40465587-177
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available within 6 months of study finishing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Infertility
Infertility, Female
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases