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

NCT01655732 | Completed Phase 2

• 1 other identifier: Rabia
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Atraumatic Restorative Treatment

EXPERIMENTAL

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

Interventions

Atraumatic Restorative Treatment PROCEDURE

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.

Also known as: ART

Atraumatic Restorative Treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead
• University of the Punjab: collaborator

Study Sites (1)

Shaikh Zayed Medical Complx

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 21861025 RESULT

MeSH Terms

Interventions

Dental Atraumatic Restorative Treatment

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Prof. Ayyaz A Khan, PhD

  Shaikh zayed Medical Complex

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

PA (1)