Clinical trial NCT03577314: Is There an Interaction Between Recurrent Miscarriage and Dental Health
Official title: Dental Health in Recurrent Miscarriage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Health
Miscarriage
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were aged from 18 to 35 years, 100 females

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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,
* fluoride supplements,
* orthodontic appliances,
* body mass index ≥ 30 kg / m2
* age of the partner is found to be over 40

Primary outcomes:
measure: recurrent miscarriage
timeFrame: below 20th week of pregnancy
Secondary outcomes:
measure: Dental Examination
timeFrame: 1 Day
measure: Periodontal Examination
timeFrame: 1 Day
measure: Clinical attachment level
timeFrame: 1 Day
measure: Plaque Examination
timeFrame: 1 Day
measure: Gingival Examination
timeFrame: 1 Day
measure: Bleeding Examination
timeFrame: 1 Day
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Dentistry Faculty
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Faculty of Medicine
Study officials:
affiliation: Recep Tayyip Erdogan University Dentistry Faculty
name: Gül Yıldız Telatar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.