Dental CariesNCT02398695
Oral Alkali Production and Caries Prevention in Children (Longitudinal)
An observational study of Dental Caries, run by University of Florida at 1 site in United States.
Trial summary
The fact that dental caries remains a major public health problem mandates that oral-health researchers explore new strategies for assessment of caries risk, as well as for caries prevention and management. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Oral Samples
- Type of treatment
- Pill or oral medicine
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 27 Aug 2015
- Phase
- Observational
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will consist of unrelated children aged between 2 and 5 years with different levels of caries experience.
Who may be able to join
- Age 2 to 7 years
Who cannot join
- Treated with antibiotics within the past 3 months
- taking any medication at the time of the study
- uses orthodontic appliance, and
- has performed oral hygiene procedures in the past 8 hour prior to the collection appointment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dental Clinical Research Unit, University of Florida
Gainesville, Florida, 32610
About this study
Official title: Oral Alkali Production and Caries Prevention in Children (Longitudinal Component)
The fact that dental caries remains a major public health problem mandates that oral-health researchers explore new strategies for assessment of caries risk, as well as for caries prevention and management. Dental caries occurs when acids produced by bacterial glycolysis of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of caries research has been on identifying and characterizing acid-generating bacteria and the mechanisms of acid resistance. The purpose of this study is to investigate over time the relationship between alkali production and caries.
Read the detailed description
This study will require a total of 6 study visits over a 2 to 3 year period. The first study visit will last about one hour. At this study visit, parent-administered questionnaires will be used to collect information on the following: (a) the participant's demographic background (age, gender, and race), (b) socio-economic status (parents' income and housing condition), (c) participant's oral health practice (feeding histories, diet habits, oral hygiene measures, and dental attendance), and (d) systemic diseases. During the study visit, the participant's complete medical and dental history will be obtained and reviewed, and a dental exam will be performed in order to determine participants' caries status, and intraoral pictures may be taken of participants' teeth. At this visit and remaining visits participants will not be allowed to brush or clean teeth using any type of oral hygiene procedures for 8 hours prior to the visit. Saliva and plaque (the solf white-yellowish material on the tooth surface) will be collected at each visit. The Investigator will use a small probe to measure the pH of the dental plaque that builds up on the teeth. The participant will be asked to dip one finger into a glass containing a buffer solution and the probe will be placed on the teeth from which plaque will be taken. Plaque samples will be collected by gently scrapping the tooth using a sterile instrument. If the participant does not have enough plaque samples, they will be asked to return on the following day.
- Conditions
- Dental Caries
- Being tested
- Oral Samples
- Keywords
- Plaque, Saliva, Caries
- Medical subject headings
- Dental Caries, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral SamplesOther
Oral samples of saliva, dental plaque and DNA will be collected between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Caries Free | Participants who do not have caries (cavities) will have oral samples collected. Receives: Other: Oral Samples | |
| Caries Active | Participants who do have caries (cavities) will have oral samples collected. Receives: Other: Oral Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6.
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from baseline to month 6
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from baseline to month 6 to month 12
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from baseline to month 6 to month 12 to month 18
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18 to month 24.
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from baseline to month 6 to month 12 to month 18 to month 24
Secondary outcomes (4)
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6.
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from baseline to month 6
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from baseline to month 6 to month 12
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from baseline to month 6 to month 12 to month 18,
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18 to month 24.
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from baseline to month 6 to month 12 to month 18 to month 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startOct 2012
- Primary completion27 Aug 2015
- Study completion27 Aug 2015
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.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Marcelle Nascimento, DDS, MS, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398695
- Sponsor's protocol ID
- 272-2012 SubStudy-N
- Other IDs
- K23DE023579, IRB201600154
- Status last verified
- Nov 2018
- First submitted
- 20 Mar 2015
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Nascimento MM, Liu Y, Kalra R, Perry S, Adewumi A, Xu X, Primosch RE, Burne RA. Oral arginine metabolism may decrease the risk for dental caries in children. J Dent Res. 2013 Jul;92(7):604-8. doi: 10.1177/0022034513487907. Epub 2013 May 2.
PubMed 23640952
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Alkali Production and Caries Prevention in Children (Longitudinal Component)
- ClinicalTrials.gov ID
- NCT02398695
- Acronym / sponsor ID
- 272-2012 SubStudy-N
- Conditions
- Dental Caries
- Keywords
- Plaque, Saliva, Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Oct 2012
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 25 Mar 2015 (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 fact that dental caries remains a major public health problem mandates that oral-health researchers explore new strategies for assessment of caries risk, as well as for caries prevention and management. Dental caries occurs when acids produced by bacterial glycolysis of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of caries research has been on identifying and characterizing acid-generating bacteria and the mechanisms of acid resistance. The purpose of this study is to investigate over time the relationship between alkali production and caries.
Detailed description
This study will require a total of 6 study visits over a 2 to 3 year period. The first study visit will last about one hour. At this study visit, parent-administered questionnaires will be used to collect information on the following: (a) the participant's demographic background (age, gender, and race), (b) socio-economic status (parents' income and housing condition), (c) participant's oral health practice (feeding histories, diet habits, oral hygiene measures, and dental attendance), and (d) systemic diseases. During the study visit, the participant's complete medical and dental history will be obtained and reviewed, and a dental exam will be performed in order to determine participants' caries status, and intraoral pictures may be taken of participants' teeth. At this visit and remaining visits participants will not be allowed to brush or clean teeth using any type of oral hygiene procedures for 8 hours prior to the visit. Saliva and plaque (the solf white-yellowish material on the tooth surface) will be collected at each visit. The Investigator will use a small probe to measure the pH of the dental plaque that builds up on the teeth. The participant will be asked to dip one finger into a glass containing a buffer solution and the probe will be placed on the teeth from which plaque will be taken. Plaque samples will be collected by gently scrapping the tooth using a sterile instrument. If the participant does not have enough plaque samples, they will be asked to return on the following day.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caries Free | – | Other: Oral SamplesParticipants who do not have caries (cavities) will have oral samples collected. |
| Caries Active | – | Other: Oral SamplesParticipants who do have caries (cavities) will have oral samples collected. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will consist of unrelated children aged between 2 and 5 years with different levels of caries experience.
Key inclusion criteria (1 listed)
- Age 2 to 7 years
Key exclusion criteria (4 listed)
- Treated with antibiotics within the past 3 months
- taking any medication at the time of the study
- uses orthodontic appliance, and
- has performed oral hygiene procedures in the past 8 hour prior to the collection appointment.
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 |
|---|---|---|
| Oral SamplesOral samples of saliva, dental plaque and DNA will be collected between the two groups. | Other | Caries Active, Caries Free |
Primary outcome
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6.
Time frame: Changes from baseline to month 6
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.
Time frame: Changes from baseline to month 6 to month 12
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.
Time frame: Changes from baseline to month 6 to month 12 to month 18
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18 to month 24.
Time frame: Changes from baseline to month 6 to month 12 to month 18 to month 24
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
4 secondary outcomes
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6.
Time frame: Changes from baseline to month 6
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.
Time frame: Changes from baseline to month 6 to month 12
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.
Time frame: Changes from baseline to month 6 to month 12 to month 18,
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18 to month 24.
Time frame: Changes from baseline to month 6 to month 12 to month 18 to month 24.
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 13 Nov 2018.
- Results publication: PubMed 23640952Nascimento MM, Liu Y, Kalra R, Perry S, Adewumi A, Xu X, Primosch RE, Burne RA. Oral arginine metabolism may decrease the risk for dental caries in children. J Dent Res. 2013 Jul;92(7):604-8. doi: 10.1177/0022034513487907. Epub 2013 May 2.
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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.
Marcelle Nascimento, DDS, MS, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by University of Florida at 1 site in United States.
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 1 inclusion and 4 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 13 Nov 2018. 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 United States. 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?
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6. (time frame: Changes from baseline to month 6). The study lists 4 primary outcomes in all. 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 NCT02398695, 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 13 Nov 2018.