Clinical trial NCT01655732: Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women
Official title: Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women, A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy
Keywords: Pregnancy
Lead sponsor: Sheikh Zayed Federal Postgraduate Medical Institute
Sponsor class: OTHER
Collaborators: name: University of the Punjab
First posted: 2012-08-02
Enrollment: 94
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Informed consent from enrolled population.
* Pregnant women having at least 3 untreated carious teeth.

Exclusion Criteria:

* Presence of any systemic diseases like diabetes, hypertension, cardiac disease.
* Deep carious lesions involving pulp.

Primary outcomes:
measure: Salivary s.mutans count
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaikh Zayed Medical Complx
state: Punjab
Study officials:
affiliation: Shaikh zayed Medical Complex
name: Prof. Ayyaz A Khan, PhD
role: STUDY_DIRECTOR
References:
citation: Volpato FC, Jeremias F, Spolidorio DM, Silva SR, Valsecki Junior A, Rosell FL. Effects of oral environment stabilization procedures on Streptococcus mutans counts in pregnant women. Braz Dent J. 2011;22(4):280-4. doi: 10.1590/s0103-64402011000400003.