Is There an Interaction Between Recurrent Miscarriage and Dental Health

Oral Health Clinical Trial

Official title:

Dental Health in Recurrent Miscarriage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577314
• Other study ID #: 40465587-179
• Status: Recruiting
• Start date: April 15, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: July 2018
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: Gül Yildiz Telatar, Dr.
• Phone: 05365404555
• Email: gulyildiz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 15, 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Miscarriage
• Oral Health

Intervention

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

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University Dentistry Faculty	Rize
Turkey	Recep Tayyip Erdogan University Faculty of Medicine	Rize

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	below 20th week of pregnancy
Secondary	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.	1 Day
Secondary	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	1 Day
Secondary	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	1 Day
Secondary	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	1 Day
Secondary	Gingival Examination	A single calibrated examiner measured gingival indices (GI) 0= Normal gingiva; Mild inflammation; Moderate inflammation; Severe inflammation	1 Day
Secondary	Bleeding Examination	A single calibrated examiner measured bleeding on probing (BOP) 0: no bleeding; 1: bleeding	1 Day

External Links

•   Institute of Dentistry, Oulu University and Hospital, Oulu, Finland