Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women

Pregnancy Clinical Trial

— ART  

Official title:

Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women, A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655732
• Other study ID #: Rabia
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2012
• Last updated: August 13, 2012
• Start date: May 2012
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Sheikh Zayed Federal Postgraduate Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Shaikh Zayed Medical Complx	Lahore	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Sheikh Zayed Federal Postgraduate Medical Institute	University of the Punjab

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Volpato FC, Jeremias F, Spolidório 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary s.mutans count	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.	6 months	No