NCT03575494

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

June 22, 2018

Last Update Submit

October 6, 2020

Conditions

Outcome Measures

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.

    12 months

Secondary Outcomes (1)

  • dental examination

    1 Day

Study Arms (2)

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

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

female infertilityhealthy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients were aged from 18 to 35 years, 100 females

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University

Rize, 53000, Turkey (Türkiye)

Location

Related 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.

    PMID: 29162952BACKGROUND

Related Links

MeSH Terms

Conditions

Dental CariesInfertility, Female

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Gül Yıldız Telatar

    Recep Tayyip Erdogan University Dentistry Faculty

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Recep Tayyip Erdogan University Faculty of Dentistry

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 2, 2018

Study Start

April 15, 2018

Primary Completion

April 15, 2019

Study Completion

February 15, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Data will be available within 6 months of study finishing

Locations