Oral HealthNCT03577314
Is There an Interaction Between Recurrent Miscarriage and Dental Health
An observational study of Oral Health and Miscarriage, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Oral infections can trigger the production of pro-inflammatory mediators that may be risk factors for miscarriage. The investigators investigated whether oral health care patterns that may promote or alleviate oral inflammation were associated with the history of miscarriage in Turkish women. 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
- Oral Health, Miscarriage
- What is being tested?
- miscarriage
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 15 May 2019
- 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
- history of at least two unexplained recurrent miscarriage below 20th week of pregnancy
- systemically healthy females with at least two normal births
- no poor obstetric history such as preeclampsia and premature birth
Who cannot join
- history of thyroid disease, hyperprolactinemia, antiphospholipid syndrome, systemic lupus erythematosus, autoimmune diseases, thrombophilia, diabetes mellitus, uterine/cervical abnormalities, polycystic ovary syndrome, active liver disease, cardiovascular disease, premature ovarian failure, acute or chronic upper respiratory tract diseases, IVF pregnancy, multiple pregnancy, preeclampsia, arterial or venous embolism, infection,
- habit of smoking, alcohol, drug or caffeine,
- abnormal embryo karyotype,
- infection with hepatitis B or C, and HIV,
- chromosomal abnormalities,
- dental fluorosis,
Show all 10Show fewer
- fluoride supplements,
- orthodontic appliances,
- body mass index ≥ 30 kg / m2
- age of the partner is found to be over 40
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Recruiting
Recep Tayyip Erdogan University Dentistry Faculty
Rize, 53000
Gül Yıldız Telatar, Dr, 05365404555, gulyildiz@gmail.com
- Active, not recruiting
Recep Tayyip Erdogan University Faculty of Medicine
Rize, 53000
About this study
Official title: Dental Health in Recurrent Miscarriage
Oral infections can trigger the production of pro-inflammatory mediators that may be risk factors for miscarriage. The investigators investigated whether oral health care patterns that may promote or alleviate oral inflammation were associated with the history of miscarriage in Turkish women.
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 miscarriage linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.
- Conditions
- Oral Health, Miscarriage
- Being tested
- miscarriage
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miscarriageOther
Also called Intraoral and Radiographic Dental Examination
(ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).
| Study group | Role | What they receive |
|---|---|---|
| miscarriage | Patients were aged from 18 to 35 years, 50 females who have history of at least two unexplained recurrent miscarriage below 20th week of pregnancy Receives: Other: miscarriage | |
| healthy | 50 systemically healthy females with at least two normal births and no poor obstetric history such as preeclampsia and premature birth Receives: Other: miscarriage |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent miscarriage
If abortion material is obtainable, it will be genetically evaluated for chromosomal abnormalities. At least 8 weeks after termination of pregnancy, karyotype analysis of both couples and thrombophilia panel ( Factor V Leiden, prothrombin gene mutation G20210A, protein S/Protein C/antithrombin deficiency and MTHFR mutations) in the study group will be requested.
Measured: below 20th week of pregnancy
Secondary outcomes (6)
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.
Measured: 1 Day
Periodontal Examination
A single calibrated examiner measured probing depth-PD, 0: healthy
- bleeding
- calculus 3:3.5-5.5 mm
4: over 5.5 mm
Measured: 1 Day
Clinical attachment level
A single calibrated examiner measured clinical attachment level- CAL, 0: 0-3 mm 1:4-5 mm 2:6-8 mm 3:over 8mm 4: 9-11 mm 5: over 12 mm
Measured: 1 Day
Plaque Examination
A single calibrated examiner measured plaque (Pl) 0:no plaque
- A film of plaque
- soft deposit s within the gingival pocket
- Abundance of soft matter within the gingival pocket
Measured: 1 Day
Gingival Examination
A single calibrated examiner measured gingival indices (GI) 0= Normal gingiva;
- Mild inflammation
- Moderate inflammation
- Severe inflammation
Measured: 1 Day
Bleeding Examination
A single calibrated examiner measured bleeding on probing (BOP) 0: no bleeding
1: bleeding
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 posted5 Jul 2018
- Study start15 Apr 2018
- Primary completionApr 2019 (estimated)
- Study completion15 May 2019 (estimated)
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 Oral HealthStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
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
- NCT03577314
- Sponsor's protocol ID
- 40465587-179
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available within 6 months of study finishing
Publications
Heimonen A, Janket SJ, Meurman JH, Furuholm J, Ackerson LK, Kaaja R. Oral health care patterns and the history of miscarriage. Oral Dis. 2008 Nov;14(8):734-40. doi: 10.1111/j.1601-0825.2008.01460.x.
PubMed 19193203
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Health in Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT03577314
- Acronym / sponsor ID
- 40465587-179
- Conditions
- Oral Health, Miscarriage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- 15 May 2019 (estimated)
- First posted
- 5 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.
Oral infections can trigger the production of pro-inflammatory mediators that may be risk factors for miscarriage. The investigators investigated whether oral health care patterns that may promote or alleviate oral inflammation were associated with the history of miscarriage in Turkish women.
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 miscarriage 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
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| miscarriage | – | Other: miscarriagePatients were aged from 18 to 35 years, 50 females who have history of at least two unexplained recurrent miscarriage below 20th week of pregnancy |
| healthy | – | Other: miscarriage50 systemically healthy females with at least two normal births and no poor obstetric history such as preeclampsia and premature birth |
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 (3 listed)
- history of at least two unexplained recurrent miscarriage below 20th week of pregnancy
- systemically healthy females with at least two normal births
- no poor obstetric history such as preeclampsia and premature birth
Key exclusion criteria (10 listed)
- history of thyroid disease, hyperprolactinemia, antiphospholipid syndrome, systemic lupus erythematosus, autoimmune diseases, thrombophilia, diabetes mellitus, uterine/cervical abnormalities, polycystic ovary syndrome, active liver disease, cardiovascular disease, premature ovarian failure, acute or chronic upper respiratory tract diseases, IVF pregnancy, multiple pregnancy, preeclampsia, arterial or venous embolism, infection,
- habit of smoking, alcohol, drug or caffeine,
- abnormal embryo karyotype,
- infection with hepatitis B or C, and HIV,
- chromosomal abnormalities,
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 |
|---|---|---|
| miscarriageAlso: Intraoral and Radiographic Dental Examination(ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s). | Other | healthy, miscarriage |
Primary outcome
recurrent miscarriage
Time frame: below 20th week of pregnancy
If abortion material is obtainable, it will be genetically evaluated for chromosomal abnormalities. At least 8 weeks after termination of pregnancy, karyotype analysis of both couples and thrombophilia panel ( Factor V Leiden, prothrombin gene mutation G20210A, protein S/Protein C/antithrombin deficiency and MTHFR mutations) in the study group will be requested.
6 secondary outcomes
Dental Examination
Time frame: 1 Day
Periodontal Examination
Time frame: 1 Day
Clinical attachment level
Time frame: 1 Day
Plaque Examination
Time frame: 1 Day
Gingival Examination
Time frame: 1 Day
Bleeding Examination
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 19193203Heimonen A, Janket SJ, Meurman JH, Furuholm J, Ackerson LK, Kaaja R. Oral health care patterns and the history of miscarriage. Oral Dis. 2008 Nov;14(8):734-40. doi: 10.1111/j.1601-0825.2008.01460.x.
- Institute of Dentistry, Oulu University and Hospital, Oulu, FinlandLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health and Miscarriage, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gül Yıldız Telatar, Dr. (05365404555, gulyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent miscarriage (time frame: below 20th week of pregnancy). 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 NCT03577314, 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 18 Jul 2018.