PregnancyPhase 2ARTNCT01655732
Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women
A Phase 2 study testing Atraumatic Restorative Treatment in people with Pregnancy, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Atraumatic Restorative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 sitePakistan
- Study dates
- May 2012to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent from enrolled population.
- Pregnant women having at least 3 untreated carious teeth.
Who cannot join
- Presence of any systemic diseases like diabetes, hypertension, cardiac disease.
- Deep carious lesions involving pulp.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women, A Randomized Control Trial
- 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Atraumatic Restorative Treatment
- Keywords
- Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative TreatmentProcedure or surgery
Also called ART
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Atraumatic Restorative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Punjab
- Responsible party
- Principal investigator, Dr.Rabia Asad, Sheikh Zayed Federal Postgraduate Medical Institute
- Investigators
- Prof. Ayyaz A Khan, PhD, Study director, Shaikh zayed Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655732
- Sponsor's protocol ID
- Rabia
- Acronym
- ART
- Status last verified
- Aug 2012
- First submitted
- 31 Jul 2012
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21861025
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atraumatic Restorative Treatment on Streptococcus Mutans Count in Saliva of Pregnant Women, A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01655732
- Acronym / sponsor ID
- ART / Rabia
- Conditions
- Pregnancy
- Keywords
- Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Collaborators
- University of the Punjab
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Restorative Treatment | Experimental | Procedure: Atraumatic Restorative TreatmentART 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent from enrolled population.
- Pregnant women having at least 3 untreated carious teeth.
Key exclusion criteria (2 listed)
- Presence of any systemic diseases like diabetes, hypertension, cardiac disease.
- Deep carious lesions involving pulp.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atraumatic Restorative TreatmentAlso: ARTART 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. | Procedure or surgery | Atraumatic Restorative Treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Results publication: PubMed 21861025Volpato 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Ayyaz A Khan, PhD study director
Shaikh zayed Medical Complex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atraumatic Restorative Treatment in people with Pregnancy, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary s.mutans count (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01655732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.