Dental CariesNCT03575494
Relationship Between Oral Health Status and Unexplained Female Infertility in Turkish Population
An observational study of Dental Caries and Female Infertility, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Female Infertility
- What is being tested?
- Intraoral and Radiographic Dental Examination
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 15 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients were aged from 18 to 35 years, 100 females
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Dental Caries, Female Infertility
- Being tested
- Intraoral and Radiographic Dental Examination
- Medical subject headings
- Dental Caries, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral and Radiographic Dental ExaminationOther
(ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).
| Study group | Role | What they receive |
|---|---|---|
| female infertility | Women who had regular menses and can't conceive despite a long-term regular sexual intercourse for more than 12 months Receives: Other: Intraoral and Radiographic Dental Examination | |
| healthy | healthy patients who had minimum two normal pregnancies Receives: Other: Intraoral and Radiographic Dental Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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;
- = 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).
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start15 Apr 2018 (estimated)
- Primary completion15 Apr 2019 (estimated)
- Study completion15 Feb 2020 (estimated)
Why it stopped: this study does not need to get a clinicaltrials number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Gül Yıldız Telatar, Principal investigator, Recep Tayyip Erdogan University Dentistry Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575494
- Sponsor's protocol ID
- 40465587-177
- Status last verified
- Oct 2020
- First submitted
- 22 Jun 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available within 6 months of study finishing
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Status and Unexplained Female Infertility
- ClinicalTrials.gov ID
- NCT03575494
- Acronym / sponsor ID
- 40465587-177
- Conditions
- Dental Caries, Female Infertility
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: this study does not need to get a clinicaltrials number
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2018 (estimated)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 15 Feb 2020 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| female infertility | – | Other: Intraoral and Radiographic Dental ExaminationWomen who had regular menses and can't conceive despite a long-term regular sexual intercourse for more than 12 months |
| healthy | – | Other: Intraoral and Radiographic Dental Examinationhealthy patients who had minimum two normal pregnancies |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients were aged from 18 to 35 years, 100 females
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral and Radiographic Dental Examination(ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s). | Other | female infertility, healthy |
Primary outcome
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.
1 secondary outcome
dental examination
Time frame: 1 Day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 29162952Khanna 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.
- Oral Health Status and Fertility TreatmentLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be available within 6 months of study finishing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gül Yıldız Telatar principal investigator
Recep Tayyip Erdogan University Dentistry Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Female Infertility, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
female infertility (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.