Dental CariesNCT02637830
In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
A study testing Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study and Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study in people with Dental Caries, run by University of Sao Paulo.
Trial summary
This study mainly compared the response of the artificial carious enamel lesions to remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel, MHDP and Buffer solutions. The lesions were then remineralised in an in situ model, with crossover and double blind design. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study and Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2012
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a stimulated physiological salivary flow rate of >1 ml.min-1
- a non-stimulated physiological salivary flow rate of >0.25 ml.min-1
- good oral health (i.e. no cavities or significant gingivitis/periodontitis)
Who cannot join
- systemic illness
- pregnancy or breastfeeding
- use of fixed or removable orthodontic appliances
- use of fluoride mouthrinse or professional fluoride application in the last 2 months.
About this study
This study mainly compared the response of the artificial carious enamel lesions to remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel, MHDP and Buffer solutions.
The lesions were then remineralised in an in situ model, with crossover and double blind design. Fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of each demineralising protocol during 3 experimental phases (3 days each). The experimental phases/treatments were: Control (Placebo dentifrice, saliva effect only), Home-care (fluoride dentifrice, 1,100 ppm F, NaF), and Professional/Home-care (varnish- 22,600 ppm F and dentifrice- 1,100 ppm F, NaF).
Read more
During the 3-day phase, the appliance was only removed during the main meals (four times a day, maximum 1 h duration each, interval between meals 2-3 h). Immediately after the meals, before replacing the appliance in the mouth, the subjects were advised to perform oral hygiene using a soft end-rounded toothbrush (Colgate® 360º Sensitive Pro-Relief TM) and dentifrice (non-fluoridated from IceFresh, Bauru, SP, Brazil or fluoridated dentifrice from Crest Procter \& Gamble, Cincinnati, OH, USA) according to the phase and dental floss (Sanifill, São Paulo, Brazil).
The remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of solution/specimen). Thereafter, the appliance was replaced in the mouth and the subjects were advised to rinse with 10 ml of water for 5 s and to expectorate. In respect to Professional/Home-care phase, the varnish (Duraphat, Colgate, SP, Brazil) was applied before the in situ study for 6h and then removed.
The enamel remineralization was quantified using transverse microradiography (% mineral recovery and lesion depth, TMR), surface and cross-sectional hardness. The data were submitted to statistical analysis (p<0.05).
- Conditions
- Dental Caries
- Being tested
- Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study, Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study, Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the studyOther
Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the studyOther
Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the studyOther
| Study group | Role | What they receive |
|---|---|---|
| Fluoride varnish and fluoride toothpaste | Experimental | Application of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days. Receives: Other: Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study; Other: Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study |
| placebo toothpaste | Placebo comparator | Application of placebo toothpaste twice a day for 3 days Receives: Other: Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study |
| Fluoride toothpaste | Active comparator | Application of fluoride toothpaste (Crest) twice a day for 3 days Receives: Other: Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The increase of mineral content (% mineral volume) using transverse microradiography
Measured: 3 days
The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness
Measured: 3 days
Decrease of lesion depth (microns) of artificial caries lesions using transverse microradiography
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Carolina Magalhães, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637830
- Sponsor's protocol ID
- 036/2011
- Status last verified
- Dec 2015
- First submitted
- 8 Dec 2015
- Last updated
- 24 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
- ClinicalTrials.gov ID
- NCT02637830
- Acronym / sponsor ID
- 036/2011
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Dec 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.
This study mainly compared the response of the artificial carious enamel lesions to remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel, MHDP and Buffer solutions.
The lesions were then remineralised in an in situ model, with crossover and double blind design. Fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of each demineralising protocol during 3 experimental phases (3 days each). The experimental phases/treatments were: Control (Placebo dentifrice, saliva effect only), Home-care (fluoride dentifrice, 1,100 ppm F, NaF), and Professional/Home-care (varnish- 22,600 ppm F and dentifrice- 1,100 ppm F, NaF).
During the 3-day phase, the appliance was only removed during the main meals (four times a day, maximum 1 h duration each, interval between meals 2-3 h). Immediately after the meals, before replacing the appliance in the mouth, the subjects were advised to perform oral hygiene using a soft end-rounded toothbrush (Colgate® 360º Sensitive Pro-Relief TM) and dentifrice (non-fluoridated from IceFresh, Bauru, SP, Brazil or fluoridated dentifrice from Crest Procter \& Gamble, Cincinnati, OH, USA) according to the phase and dental floss (Sanifill, São Paulo, Brazil).
The remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of solution/specimen). Thereafter, the appliance was replaced in the mouth and the subjects were advised to rinse with 10 ml of water for 5 s and to expectorate. In respect to Professional/Home-care phase, the varnish (Duraphat, Colgate, SP, Brazil) was applied before the in situ study for 6h and then removed.
The enamel remineralization was quantified using transverse microradiography (% mineral recovery and lesion depth, TMR), surface and cross-sectional hardness. The data were submitted to statistical analysis (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride varnish and fluoride toothpaste | Experimental | Other: Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study, Other: Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the studyApplication of fluoride varnish (Duraphat) at the begining of the study. Application of fluoride toothpaste (Crest) twice a day for 3 days. |
| placebo toothpaste | Placebo comparator | Other: Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the studyApplication of placebo toothpaste twice a day for 3 days |
| Fluoride toothpaste | Active comparator | Other: Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the studyApplication of fluoride toothpaste (Crest) twice a day for 3 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a stimulated physiological salivary flow rate of >1 ml.min-1
- a non-stimulated physiological salivary flow rate of >0.25 ml.min-1
- good oral health (i.e. no cavities or significant gingivitis/periodontitis)
Key exclusion criteria (4 listed)
- systemic illness
- pregnancy or breastfeeding
- use of fixed or removable orthodontic appliances
- use of fluoride mouthrinse or professional fluoride application in the last 2 months.
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 |
|---|---|---|
| Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study | Other | Fluoride varnish and fluoride toothpaste |
| Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study | Other | Fluoride toothpaste, Fluoride varnish and fluoride toothpaste |
| Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study | Other | placebo toothpaste |
Primary outcome
The increase of mineral content (% mineral volume) using transverse microradiography
Time frame: 3 days
The increase of hardness (KHN or KgF/mm2) artificial caries lesions using surface and cross-sectional hardness
Time frame: 3 days
Decrease of lesion depth (microns) of artificial caries lesions using transverse microradiography
Time frame: 3 days
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 24 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study and Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study in people with Dental Caries, run by University of Sao Paulo.
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 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 24 Dec 2015. 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.
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?
The increase of mineral content (% mineral volume) using transverse microradiography (time frame: 3 days). The study lists 3 primary outcomes in all. 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 24 Dec 2015.