NCT03577314

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

June 21, 2018

Last Update Submit

July 17, 2018

Conditions

Oral HealthMiscarriage

Outcome Measures

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.

    below 20th week of pregnancy

Secondary Outcomes (6)

  • Dental Examination

    1 Day

  • Periodontal Examination

    1 Day

  • Clinical attachment level

    1 Day

  • Plaque Examination

    1 Day

  • Gingival Examination

    1 Day

  • +1 more secondary outcomes

Study Arms (2)

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

miscarriageOTHER

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

Also known as: Intraoral and Radiographic Dental Examination
healthymiscarriage

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients were aged from 18 to 35 years, 100 females

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Recep Tayyip Erdogan University Dentistry Faculty

Rize, 53000, Turkey (Türkiye)

RECRUITING

Recep Tayyip Erdogan University Faculty of Medicine

Rize, 53000, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Related 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.

    PMID: 19193203BACKGROUND

Related Links

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Gül Yıldız Telatar

    Recep Tayyip Erdogan University Dentistry Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gül Yıldız Telatar, Dr.

CONTACT

05365404555gulyildiz@gmail.com

Beril Gürlek, Dr.

CONTACT

05535979403berilsem@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 5, 2018

Study Start

April 15, 2018

Primary Completion

April 1, 2019

Study Completion

May 15, 2019

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

TU(2)