Dental CariesACNCT01449136
Use of Antibacterial Cement in Infected Dentin
A study testing Antibacterial cement in people with Dental Caries, run by University of Pernambuco at 1 site in Brazil.
Trial summary
Dental materials with antibacterial properties can prevent the harmful effects caused by oral cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of antibacterial cement for sealing infected dentin in atraumatic restorations of primary molars. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Antibacterial cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Feb 2010
- Phase
- Interventional
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- signed consent from a parent or guardian;
- primary molars with carious lesions on the inner half of dentin;
- access of caries lesions to dentin spoons.
Who cannot join
- damaged pulp determined clinically (for pain, fistulas, tooth mobility);
- damaged pulp determined radiography (bone or dental pathology);
- children taking antibiotics;
- children who refused the treatment;
- children had systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth
Dental materials with antibacterial properties can prevent the harmful effects caused by oral cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of antibacterial cement for sealing infected dentin in atraumatic restorations of primary molars.
Read the detailed description
The study enrolled 45 children (45 teeth) between 5 and 8 years of age, of both genders, divided into two groups. In group A (GA; n=22), the cavities were lined with conventional glass ionomer cement (Vidrion F®) and in group B (GB; n=23), with antibacterial cement (Vidrion F® containing 1% each of metronidazole, ciprofloxacin, and cefaclor). Both groups were restored with Ketac Molar Easymix®. Molars with carious lesions on the inner half of dentin without clinical or radiographic pulp damage were selected. Patients were evaluated clinically (for pain, fistulas, or mobility) and radiographically (area of caries, periapical region, and furcation of teeth) after 1, 3, 6, and 12 months.
- Conditions
- Dental Caries
- Being tested
- Antibacterial cement
- Keywords
- Antibacterial agents, Deciduous Teeth, Clinical Trial
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibacterial cementOther
Also called Antibacterial cement (Formula & Ação, São Paulo, Brazil)
Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor
| Study group | Role | What they receive |
|---|---|---|
| antibacterial cement | Experimental | Not described Receives: Other: Antibacterial cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of successful restorations with a dental liner with antibiotics
The absence of pain, fistulas, and mobility throughout the study was considered clinical success and the decreased or unchanged area of caries (obtained by a software to accurately measure distances between anatomical points selected by the operator of radiolucent zone beneath the restoration) and no bone or dental disorder was detected was considered radiographic success.
Overall success was defined as clinical and radiographic success being achieved simultaneously.
Measured: differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
- Study completionFeb 2010
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 Dental CariesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jainara Maria Soares Ferreira, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449136
- Sponsor's protocol ID
- 1535/07
- Acronym
- AC
- Status last verified
- Sep 2011
- First submitted
- 28 Aug 2011
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferreira JM, Pinheiro SL, Sampaio FC, Menezes VA. Use of glass ionomer cement containing antibiotics to seal off infected dentin: a randomized clinical trial. Braz Dent J. 2013;24(1):68-73. doi: 10.1590/0103-6440201301925.
PubMed 23657417
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth
- ClinicalTrials.gov ID
- NCT01449136
- Acronym / sponsor ID
- AC / 1535/07
- Conditions
- Dental Caries
- Keywords
- Antibacterial agents, Deciduous Teeth, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Oct 2011 (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.
Dental materials with antibacterial properties can prevent the harmful effects caused by oral cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of antibacterial cement for sealing infected dentin in atraumatic restorations of primary molars.
Detailed description
The study enrolled 45 children (45 teeth) between 5 and 8 years of age, of both genders, divided into two groups. In group A (GA; n=22), the cavities were lined with conventional glass ionomer cement (Vidrion F®) and in group B (GB; n=23), with antibacterial cement (Vidrion F® containing 1% each of metronidazole, ciprofloxacin, and cefaclor). Both groups were restored with Ketac Molar Easymix®. Molars with carious lesions on the inner half of dentin without clinical or radiographic pulp damage were selected. Patients were evaluated clinically (for pain, fistulas, or mobility) and radiographically (area of caries, periapical region, and furcation of teeth) after 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antibacterial cement | Experimental | Other: Antibacterial cement |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- signed consent from a parent or guardian;
- primary molars with carious lesions on the inner half of dentin;
- access of caries lesions to dentin spoons.
Key exclusion criteria (5 listed)
- damaged pulp determined clinically (for pain, fistulas, tooth mobility);
- damaged pulp determined radiography (bone or dental pathology);
- children taking antibiotics;
- children who refused the treatment;
- children had systemic disease.
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 |
|---|---|---|
| Antibacterial cementAlso: Antibacterial cement (Formula & Ação, São Paulo, Brazil)Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor | Other | antibacterial cement |
Primary outcome
number of successful restorations with a dental liner with antibiotics
Time frame: differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 months.
The absence of pain, fistulas, and mobility throughout the study was considered clinical success and the decreased or unchanged area of caries (obtained by a software to accurately measure distances between anatomical points selected by the operator of radiolucent zone beneath the restoration) and no bone or dental disorder was detected was considered radiographic success. Overall success was defined as clinical and radiographic success being achieved simultaneously.
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 10 Oct 2011.
- Derived from this study: PubMed 23657417Ferreira JM, Pinheiro SL, Sampaio FC, Menezes VA. Use of glass ionomer cement containing antibiotics to seal off infected dentin: a randomized clinical trial. Braz Dent J. 2013;24(1):68-73. doi: 10.1590/0103-6440201301925.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibacterial cement in people with Dental Caries, run by University of Pernambuco at 1 site in Brazil.
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 3 inclusion and 5 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 10 Oct 2011. 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 Brazil. 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.
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?
number of successful restorations with a dental liner with antibiotics (time frame: differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 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 NCT01449136, 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 10 Oct 2011.