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

This study has been completed.
Sponsor:
Collaborator:
University of the Punjab
Information provided by (Responsible Party):
Dr.Rabia Asad, Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier:
NCT01655732
First received: July 31, 2012
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Pregnancy
Procedure: Atraumatic Restorative Treatment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women, A Randomized Control Trial

Further study details as provided by Sheikh Zayed Federal Postgraduate Medical Institute:

Primary Outcome Measures:
  • Salivary s.mutans count [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 94
Study Start Date: May 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655732

Locations
Pakistan
Shaikh Zayed Medical Complx
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Sheikh Zayed Federal Postgraduate Medical Institute
University of the Punjab
Investigators
Study Director: Prof. Ayyaz A Khan, PhD Shaikh zayed Medical Complex
  More Information

Publications:
Responsible Party: Dr.Rabia Asad, Principal Investigator, Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier: NCT01655732     History of Changes
Other Study ID Numbers: Rabia
Study First Received: July 31, 2012
Last Updated: August 13, 2012
Health Authority: Pakistan: Ministry of Health

Keywords provided by Sheikh Zayed Federal Postgraduate Medical Institute:
Pregnancy

ClinicalTrials.gov processed this record on October 19, 2014