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Is There an Interaction Between Recurrent Miscarriage and Dental Health

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ClinicalTrials.gov Identifier: NCT03577314
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital

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.

Condition or disease Intervention/treatment
Oral Health Miscarriage 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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dental Health in Recurrent Miscarriage
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Intraoral and Radiographic Dental Examination




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Dental Examination [ Time Frame: 1 Day ]

    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.

  2. Periodontal Examination [ Time Frame: 1 Day ]

    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


  3. Clinical attachment level [ Time Frame: 1 Day ]
    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

  4. Plaque Examination [ Time Frame: 1 Day ]

    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

  5. Gingival Examination [ Time Frame: 1 Day ]

    A single calibrated examiner measured gingival indices (GI) 0= Normal gingiva;

    1. Mild inflammation
    2. Moderate inflammation
    3. Severe inflammation

  6. Bleeding Examination [ Time Frame: 1 Day ]

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

    1: bleeding




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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients were aged from 18 to 35 years, 100 females
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577314


Contacts
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Contact: Gül Yıldız Telatar, Dr. 05365404555 gulyildiz@gmail.com
Contact: Beril Gürlek, Dr. 05535979403 berilsem@yahoo.com

Locations
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Turkey
Recep Tayyip Erdogan University Dentistry Faculty Recruiting
Rize, Turkey, 53000
Contact: Gül Yıldız Telatar, Dr    05365404555    gulyildiz@gmail.com   
Recep Tayyip Erdogan University Faculty of Medicine Active, not recruiting
Rize, Turkey, 53000
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Investigators
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Principal Investigator: Gül Yıldız Telatar Recep Tayyip Erdogan University Dentistry Faculty

Additional Information:
Publications:
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Responsible Party: Gul Yildiz Telatar, Principal Investigator, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03577314     History of Changes
Other Study ID Numbers: 40465587-179
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be available within 6 months of study finishing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications