Is There an Interaction Between Recurrent Miscarriage and Dental Health

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.

Study Overview

• Status: Unknown
• Conditions: Miscarriage; Oral Health
• Intervention / Treatment: Other: miscarriage

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53000
    • Active, not recruiting
    • Recep Tayyip Erdogan University Faculty of Medicine
  • Rize, Turkey, 53000
    • Recruiting
    • Recep Tayyip Erdogan University Dentistry Faculty
    • Contact: Gül Yıldız Telatar, Dr; Phone Number: 05365404555; Email: gulyildiz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients were aged from 18 to 35 years, 100 females

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: miscarriage; (ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).; Other Names: Intraoral and Radiographic Dental Examination
healthy; 50 systemically healthy females with at least two normal births and no poor obstetric history such as preeclampsia and premature birth	Other: miscarriage; (ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).; Other Names: Intraoral and Radiographic Dental Examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Gingival Examination	A single calibrated examiner measured gingival indices (GI) 0= Normal gingiva; Mild inflammation; Moderate inflammation; Severe inflammation	1 Day
Bleeding Examination	A single calibrated examiner measured bleeding on probing (BOP) 0: no bleeding 1: bleeding	1 Day

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Publications and helpful links

General 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): May 15, 2019

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Habitual
• Other Study ID Numbers: 40465587-179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data will be available within 6 months of study finishing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No