Dental CariesPhase 2NCT02168374
Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline
A Phase 2 study testing Indirect pulp treatment in people with Dental Caries, run by Aline R F de Castilho.
Trial summary
This study assessed the clinical performance of a resin-modified glass ionomer cement containing different concentrations of chlorhexidine digluconate and doxycycline hyclate. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Indirect pulp treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Oct 2011
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- an active deep carious lesion at the internal half of the dentine thickness of a primary molar that had not been previously restored and that involved the occlusal or occlusoproximal surface;
- the absence of signs of irreversible damage to the pulp
- the absence of radiolucencies at the interradicular or periapical region or thickening of the periodontal spaces, absence of internal and external root resorption, absence of calcification of the pulp tissue
- children presenting no systemic disease or those not using medications.
Who cannot join
- presence of signs of irreversible damage to the pulp
- children presenting systemic disease or those using medications.
About this study
Official title: Biological and Physicomechanical Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline
This study assessed the clinical performance of a resin-modified glass ionomer cement containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.
Read the detailed description
This study aimed to evaluate the in vivo microbiologic action of the best concentration of chlorhexidine and doxycycline associated with the resin-modified glass ionomer cement applied on remaining dentine after indirect pulp treatment.
- Conditions
- Dental Caries
- Being tested
- Indirect pulp treatment
- Keywords
- Glass ionomer cement, Indirect pulp therapy
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect pulp treatmentOther
Carious dentine was sampled from the mesial portion of the cavity floor and the pulpal wall was entirely covered with one of the randomly selected materials: GIC containing 4.5% DOX; GIC containing 1.25% CHX or GIC as a control group. The antimicrobial concentrations were chosen based in the previous in vitro results obtained in this study. The cavities were then temporarily restored using a conventional GIC. Within 3 months after the initial treatment,the materials were carefully and completely removed, a new dentine sample was collected, and the teeth were then restored with a light-cured composite resin using a bonding system, after a new placement of the initial liner material.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine - CHX | Experimental | Deciduous teeth were filled with GIC containing 1.25% chlorhexidine. Receives: Other: Indirect pulp treatment |
| Doxycycline - DOX | Experimental | Deciduous teeth were filled with GIC containing 4.5% doxycycline. Receives: Other: Indirect pulp treatment |
| Glass ionomer cement - GIC | Placebo comparator | Deciduous teeth were filled with GIC without chlorhexidine or doxycycline. Receives: Other: Indirect pulp treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.
Within 3 months after the initial treatment, the teeth were submitted to clinical and radiographic examination to determine signs and symptoms of pulp vitality.
Measured: up to 3 months
Secondary outcomes (1)
Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.
Dentine samples were collected at baseline and after 3 months of the treatment for microbiological evaluation (colony-forming unit - CFU).
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionOct 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aline R F de Castilho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-investigator, Aline R F de Castilho, University of Campinas, Brazil
- Investigators
- Aline RF Castilho, PhD, Principal investigator, Piracicaba Dental School, Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168374
- Sponsor's protocol ID
- PGICACD
- Other IDs
- FAPESP
- Status last verified
- Jun 2014
- First submitted
- 3 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
de Castilho AR, Duque C, Negrini Tde C, Sacono NT, de Paula AB, de Souza Costa CA, Spolidorio DM, Puppin-Rontani RM. In vitro and in vivo investigation of the biological and mechanical behaviour of resin-modified glass-ionomer cement containing chlorhexidine. J Dent. 2013 Feb;41(2):155-63. doi: 10.1016/j.jdent.2012.10.014. Epub 2012 Oct 30.
PubMed 23123495
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Physicomechanical Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline
- ClinicalTrials.gov ID
- NCT02168374
- Acronym / sponsor ID
- PGICACD
- Conditions
- Dental Caries
- Keywords
- Glass ionomer cement, Indirect pulp therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aline R F de CastilhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Jun 2014 (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.
This study assessed the clinical performance of a resin-modified glass ionomer cement containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.
Detailed description
This study aimed to evaluate the in vivo microbiologic action of the best concentration of chlorhexidine and doxycycline associated with the resin-modified glass ionomer cement applied on remaining dentine after indirect pulp treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine - CHX | Experimental | Other: Indirect pulp treatmentDeciduous teeth were filled with GIC containing 1.25% chlorhexidine. |
| Doxycycline - DOX | Experimental | Other: Indirect pulp treatmentDeciduous teeth were filled with GIC containing 4.5% doxycycline. |
| Glass ionomer cement - GIC | Placebo comparator | Other: Indirect pulp treatmentDeciduous teeth were filled with GIC without chlorhexidine or doxycycline. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- an active deep carious lesion at the internal half of the dentine thickness of a primary molar that had not been previously restored and that involved the occlusal or occlusoproximal surface;
- the absence of signs of irreversible damage to the pulp
- the absence of radiolucencies at the interradicular or periapical region or thickening of the periodontal spaces, absence of internal and external root resorption, absence of calcification of the pulp tissue
- children presenting no systemic disease or those not using medications.
Key exclusion criteria (2 listed)
- presence of signs of irreversible damage to the pulp
- children presenting systemic disease or those using medications.
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 |
|---|---|---|
| Indirect pulp treatmentCarious dentine was sampled from the mesial portion of the cavity floor and the pulpal wall was entirely covered with one of the randomly selected materials: GIC containing 4.5% DOX; GIC containing 1.25% CHX or GIC as a control group. The antimicrobial concentrations were chosen based in the previous in vitro results obtained in this study. The cavities were then temporarily restored using a conventional GIC. Within 3 months after the initial treatment,the materials were carefully and completely removed, a new dentine sample was collected, and the teeth were then restored with a light-cured composite resin using a bonding system, after a new placement of the initial liner material. | Other | Chlorhexidine - CHX, Doxycycline - DOX, Glass ionomer cement - GIC |
Primary outcome
Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.
Time frame: up to 3 months
Within 3 months after the initial treatment, the teeth were submitted to clinical and radiographic examination to determine signs and symptoms of pulp vitality.
1 secondary outcome
Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.
Time frame: up to 3 months
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 23 Jun 2014.
- Results publication: PubMed 23123495de Castilho AR, Duque C, Negrini Tde C, Sacono NT, de Paula AB, de Souza Costa CA, Spolidorio DM, Puppin-Rontani RM. In vitro and in vivo investigation of the biological and mechanical behaviour of resin-modified glass-ionomer cement containing chlorhexidine. J Dent. 2013 Feb;41(2):155-63. doi: 10.1016/j.jdent.2012.10.014. Epub 2012 Oct 30.
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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.
Aline RF Castilho, PhD principal investigator
Piracicaba Dental School, Unicamp
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indirect pulp treatment in people with Dental Caries, run by Aline R F de Castilho.
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 4 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 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX. (time frame: up to 3 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 NCT02168374, 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 23 Jun 2014.