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Status unknownNCT03577314Updated Jul 18, 2018

Is There an Interaction Between Recurrent Miscarriage and Dental Health

An observational study in Oral Health and Miscarriage, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Status unknown at 2 sites in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 35 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Oral Health
  • Miscarriage
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In context

Abortion, Spontaneous

320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 140 observational studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients were aged from 18 to 35 years, 100 females

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • healthy

    50 systemically healthy females with at least two normal births and no poor obstetric history such as preeclampsia and premature birth

    Other: miscarriage

Interventions

  • Othermiscarriage

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

    Also known as: Intraoral and Radiographic Dental Examination

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: below 20th week of pregnancy

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; 1. = first visible sign of noncavitated lesion seen only when the tooth is dried; 2. = visible noncavitated lesion seen when wet and dry; 3. = microcavitation in enamel; 4. = noncavitated lesion extending into dentine seen as an undermining shadow; 5. = small cavitated lesion with visible dentine: less than 50% of surface; 6. = large cavitated lesions with visible dentine in more than 50% of the surface.

    Time frame: 1 Day

  2. Periodontal Examination

    A single calibrated examiner measured probing depth-PD, 0: healthy 1. bleeding 2. calculus 3:3.5-5.5 mm 4: over 5.5 mm

    Time frame: 1 Day

  3. 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

    Time frame: 1 Day

  4. Plaque Examination

    A single calibrated examiner measured plaque (Pl) 0:no plaque 1. A film of plaque 2. soft deposit s within the gingival pocket 3. Abundance of soft matter within the gingival pocket

    Time frame: 1 Day

  5. Gingival Examination

    A single calibrated examiner measured gingival indices (GI) 0= Normal gingiva; 1. Mild inflammation 2. Moderate inflammation 3. Severe inflammation

    Time frame: 1 Day

  6. Bleeding Examination

    A single calibrated examiner measured bleeding on probing (BOP) 0: no bleeding 1: bleeding

    Time frame: 1 Day

07

Study locations

1 of 2 sites recruiting
  • Recep Tayyip Erdogan University Dentistry Faculty
    Rize, 53000, Turkey
    Recruiting
  • Recep Tayyip Erdogan University Faculty of Medicine
    Rize, 53000, Turkey
    Active, not recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — Data will be available within 6 months of study finishing

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03577314
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
Gul Yildiz Telatar (Principal Investigator, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Jul 5, 2018
Start date
Apr 15, 2018
Primary completion
Apr 2019 (estimated)
Completion
May 15, 2019 (estimated)
Last update
Jul 18, 2018

Study contacts

Gül Yıldız Telatar, Dr.
Contact
gulyildiz@gmail.com
05365404555
Beril Gürlek, Dr.
Contact
berilsem@yahoo.com
05535979403
Gül Yıldız Telatar
principal investigator · Recep Tayyip Erdogan University Dentistry Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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