Dental Biofilm pHPhase 2SPMedicinesNCT01819350
In Vivo Study of Sucrose and Liquid Oral Pediatric Medicines of Long-term Effect on Dental Biofilm pH
A Phase 2 study testing G1, G2 and G3 and G4 and G5 in people with Dental Biofilm pH, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The aims of this study were to determine the sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Biofilm pH
- What is being tested?
- G1, G2 and G3 and G4 and G5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Aug 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 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 22 years;
- Having Oral hygiene adequate (OHI<1.1);
- Having 20 natural teeth incluing molar;
- Not havind oral disease.
Who cannot join
- Biofilm baseline pH > 5,5;
- Not signature consent term;
- Using orthodontic appliance;
- Having used medicines last 3 months;
- Pregant woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Avaliação in Vivo do Potencial cariogênico e Erosivo de Bebidas e Medicamentos pediátricos líquidos Intra-orais
The aims of this study were to determine the sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.
Read the detailed description
Te study was carried out with 12 subjects that were refrained from brushing their teeth for 28 h and did not eat or drink for at least 3 h prior to each appointment. Dental biofilm pH was measured in the cervical and proximal regions of anterior teeth with beetrode-type microelectrode coupled to a potentiometer. The biofilm was submitted nine paediatric medicines a long term and sucrose (negative control). pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.
- Conditions
- Dental Biofilm pH
- Being tested
- G1, G2 and G3, G4 and G5
- Keywords
- Dental caries, Sucrose, Oral administration, Ion Concentration of Hydrogen, Pediatric medicines
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G1, G2 and G3Other
Nutritional, respiratory and endocrine group applicated 12 subjects
G4 and G5Other
Application of trhree pediadic medidines of antibiotic group on dental biofilm 12 subjects
| Study group | Role | What they receive |
|---|---|---|
| G4 and G5 | Experimental | Application of antibiotic group of pediatric medicines and control group (sucrose 10 %)on dental biofilm. Receives: Other: G4 and G5 |
| G1, G2 and G3 | Experimental | Application of Nutritional, Respiratory and Endocrine groups medicines pediatric on dental biofilm Receives: Other: G1, G2 and G3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH
pH was measured in the cervical and proximal regions of anterior teeth dental biofilm with beetrode-type microelectrode coupled to a potentiometer
Measured: 6 months
Secondary outcomes (1)
Evaluation of sucrose antibiotic group and control negative group effect on dental biofilm
The biofilm was submitted antibiotic group and negative control group. pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Biofilm pHStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Correia Sampaio, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819350
- Sponsor's protocol ID
- SOPM-UFPB
- Acronym
- SPMedicines
- Status last verified
- Mar 2013
- First submitted
- 24 Mar 2013
- Last updated
- 27 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avaliação in Vivo do Potencial cariogênico e Erosivo de Bebidas e Medicamentos pediátricos líquidos Intra-orais
- ClinicalTrials.gov ID
- NCT01819350
- Acronym / sponsor ID
- SPMedicines / SOPM-UFPB
- Conditions
- Dental Biofilm pH
- Keywords
- Dental caries, Sucrose, Oral administration, Ion Concentration of Hydrogen, Pediatric medicines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Mar 2013 (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.
The aims of this study were to determine the sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.
Detailed description
Te study was carried out with 12 subjects that were refrained from brushing their teeth for 28 h and did not eat or drink for at least 3 h prior to each appointment. Dental biofilm pH was measured in the cervical and proximal regions of anterior teeth with beetrode-type microelectrode coupled to a potentiometer. The biofilm was submitted nine paediatric medicines a long term and sucrose (negative control). pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G4 and G5 | Experimental | Other: G4 and G5Application of antibiotic group of pediatric medicines and control group (sucrose 10 %)on dental biofilm. |
| G1, G2 and G3 | Experimental | Other: G1, G2 and G3Application of Nutritional, Respiratory and Endocrine groups medicines pediatric on dental biofilm |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 22 years;
- Having Oral hygiene adequate (OHI<1.1);
- Having 20 natural teeth incluing molar;
- Not havind oral disease.
Key exclusion criteria (5 listed)
- Biofilm baseline pH > 5,5;
- Not signature consent term;
- Using orthodontic appliance;
- Having used medicines last 3 months;
- Pregant woman.
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 |
|---|---|---|
| G1, G2 and G3Nutritional, respiratory and endocrine group applicated 12 subjects | Other | G1, G2 and G3 |
| G4 and G5Application of trhree pediadic medidines of antibiotic group on dental biofilm 12 subjects | Other | G4 and G5 |
Primary outcome
Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH
Time frame: 6 months
pH was measured in the cervical and proximal regions of anterior teeth dental biofilm with beetrode-type microelectrode coupled to a potentiometer
1 secondary outcome
Evaluation of sucrose antibiotic group and control negative group effect on dental biofilm
Time frame: 12 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 27 Mar 2013.
Related trials for Dental Biofilm pH
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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 Phase 2 study testing G1, G2 and G3 and G4 and G5 in people with Dental Biofilm pH, run by Federal University of Paraíba 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 4 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 27 Mar 2013. 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.
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?
Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2013.