Clinical Trials Logo

Clinical Trial Summary

S. mutans counts have been found to be high in women with high level of untreated caries. In Pakistan 95% of all carious lesions are untreated that is an alarming situation. A majority of mother's have high level of caries and pose an increase risk of vertically transmitting it to their children. Therefore, the aim of this study is to determine the effect of A Traumatic Restorative Treatment(ART) in reducing S. mutans count in pregnant women and indirectly reduce the vertical transmission of S. mutans to their children so that ART as a preventive program may be provided and promoted in periurban areas where there is a lack of accessibility to oral health care.


Clinical Trial Description

Dental caries is a multifactorial bacterial disease that is a significant public health problem in many countries.Microbiological and molecular studies show that there are increase chances of caries development in pregnant women.The reason is that Pregnancy is a condition involving many physical and physiological changes that may lead to many temporary adaptive changes in the body structure. This occurs due to release of number of hormones as estrogen, progesterone, relaxin and gonadotropin.

Studies using phenotyping and genotyping techniques have strongly proposed that mother is the primary source of infection for children who carry S. mutans strains and saliva is the main source of S. mutans transfer.The rate and degree of transmission depends on degree of infection of the parent, caretaker or playmate, the frequency of contact with the infant and his/her diet and immune status.Recent studies show that infants can get colonize by S. mutans from their mothers before the eruption of their primary teeth.

Hames et al (2006) has found that there is a positive correlation between the infected children and their parents with high S. mutans count.It was found that parents who had high levels of S. mutans in their saliva were the source of transmission of S. mutans in their children concluding that several preventive programs could be beneficial to prevent vertical transmission from mothers to infants.

Studies have also shown that preventive care measures in pregnant women or mother with younger children leads to reduction in S. mutans levels in them with subsequent decrease in colonization of these microorganisms and caries development.Recent research work has also reported that preventive program applied to the pregnant women reduce both the amount of plaque and S. mutans colonization and thus has a positive effect.

There are few interventional studies to determine the effect of oral environment stabilization (OES) procedure on S. mutans count in pregnant women through ART. Volpato et al (2011) found that there is a decrease in S. mutans colony forming units counts ,with a statistically significant difference (p<0.0001),between pregnant women's saliva samples before and after OES.And he concluded that OES is an effective clinical procedure in diminishing the number of Streptococcus mutans colony forming units in the saliva of high-caries risk pregnant women. This management is simple and effective, equivalent to the basic treatment needs of pregnant women that look for dental care in public service. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01655732
Study type Interventional
Source Sheikh Zayed Federal Postgraduate Medical Institute
Contact
Status Completed
Phase Phase 2
Start date May 2012
Completion date July 2012

See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Terminated NCT02546193 - Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction N/A