Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women (ART)
|ClinicalTrials.gov Identifier: NCT01655732|
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : August 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Procedure: Atraumatic Restorative Treatment||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women, A Randomized Control Trial|
|Study Start Date :||May 2012|
|Primary Completion Date :||July 2012|
|Study Completion Date :||July 2012|
Experimental: Atraumatic Restorative Treatment
ART is Atraumatic Restorative Treatment involving removal of soft carious enamel and dentine by hand instruments only and then restore the resulting cavity and adjacent pits and fissures with an adhesive restorative material.
Procedure: Atraumatic Restorative Treatment
ART is simple uninvasive technique involving removal of soft carious enamel and dentine by hand instrument only and then restore the cavity with adhesive restorative material.
Other Name: ART
- Salivary s.mutans count [ Time Frame: 6 months ]Atraumatic Restorative Treatment reduces the Streptococcus mutans count in oral flora of pregnant women that will indirectly reduces vertical transmission of Streptococcus mutans from mothers to infants.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655732
|Shaikh Zayed Medical Complx|
|Lahore, Punjab, Pakistan, 54000|
|Study Director:||Prof. Ayyaz A Khan, PhD||Shaikh zayed Medical Complex|