Dental CariesPhase 3NCT05143086
Evaluation in Vivo of Mouthwash With Nanoencapsulated Fluoride
A Phase 3 study testing Mouthwash 100% Nano-F, Mouthwash 50% Nano-F and Mouthwash standard in people with Dental Caries, run by Fabio Correia Sampaio at 1 site in Brazil.
Trial summary
The literature recognizes that fluoride is the most widely used and studied means for dental remineralization. The use of fluoride mouthwashes is shown as an effective way to increase the fluoride intraoral availability. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Mouthwash 100% Nano-F, Mouthwash 50% Nano-F and Mouthwash standard
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2016to 20 Dec 2017
- Phase
- Phase 3
- 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 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- resident in João Pessoa;
- Decayed, Missing, Filled Index<6;
- Healthy
Who cannot join
- orthodontic treatment;
- gingivitis;
- Periodontal disease;
- Smokers;
- Present active tooth decay;
- Tooth sensitivity;
- Those undergoing treatment with fluoride products and / or use of antimicrobials in the past four weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation in Vivo of Experimental Mouthwash With Nanoencapsulated Fluoride
The literature recognizes that fluoride is the most widely used and studied means for dental remineralization. The use of fluoride mouthwashes is shown as an effective way to increase the fluoride intraoral availability. However, the current challenge is the substantivity, so new compounds have been introduced into these formulations. This study aims to evaluate the in vivo effect of fluoride mouthwash containing nanoencapsulated Fluoride (NanoF) - in fluoride retention in saliva and dental plaque. A study of the clinical and laboratory type, crossover, double-blind, randomized will be held. After sample calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed, missing, and filled teeth index less than 6 and residents in brazilian northeast capital will be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after rinsing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3 mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium fluoride. Between weeks of use, rinsing will be extended washout (without fluoride) to avoid carryover effect. Inferential data analysis will be carried out, considering the amount of alpha <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in the oral fluids promoted by the Nanoencapsulated Fluoride may have important impact on Des-Re process and in the control of dental caries.
Read the detailed description
- Study design It is a quantitative study of double-blind randomized crossover clinical type with inductive approach and documentation of technical and direct observation with measurements in the laboratory. In order to assess the bioavailability of intraoral fluoride week after the use of fluoride mouthwashes containing Nanoencapsulated Fluoride, it will be collected biofilm samples 1h and 12 h after rinse; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. The data will be obtained by physical and chemical analysis of the samples of fluoride (F). Therefore, the study will consist of two interrelated steps: a clinical phase for biofilm collection and saliva; and laboratory stage for fluoride analysis in the samples. Will be conducted pilot test with three participants before the start of the study.
- Sample Size The sample size calculation was performed using fluoride concentration data in dental biofilm previous study and taking effect size difference between the experimental mouthwash (100% Nanoencapsulated Fluoride ) and positive control of at least 3.4 ppm of F- in biofilm after 12 hours, namely, 25%. Admitting experimental protocol with beta error of 10% alpha error of 5%, one-tailed and statistical power of 90%, the sample size was calculated for 6 people. For the calculation we used the Excel software and mathematical formula for clinical trials of superiority given. Adding sample loss resulted in 12 people.
- Experimental Mouthwash For this study will be used four mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride, Free sodium fluoride, Without fluoride. The mouthwash, made available by the company from Brazil are packed in the same packaging and have the taste of mint. Except wash out the packing with mouthwash will be identified by letters (A, B and C) by an independent researcher. The letters code will not be revealed to the participants nor the researcher who will accompany them. These will be drawn at random for daily use for seven days in four times, giving an interval of one week wash-out between them. In these periods of wash-out will use a mouthwash without fluoride. In the end, all study participants will use the 5 experimental mouthwash at different times. A dentifrice without fluoride will be used by the participant during the study.
- Clinical phase The participant will be informed about the study and after its acceptance, he/she will initiate the study. Initially will be clinical examination in order to report the presence of any of the exclusion criteria already listed. After verifying the absence of these criteria, there will be a dental prophylaxis pumice for removal of this biofilm and in some cases may be made supragingival scraping. The patient will be advised not to make use of any fluoride product during the experiment. At first, volunteers are instructed to use a mouthwash without fluoride (wash out) the first week, in order to equate the study participants and eliminate any potential carryover effects of toothpaste or mouthwash used previously. The participant will get a packing of mouthwash and will be instructed to brush their teeth for 1 minute with the dentifrice without fluoride and rinse with 10 mL of mouthwash for 1 min twice a day (morning and night). On the seventh day, the participant will be instructed to brush only the occlusal surfaces of your teeth, to allow biofilm accumulation of flat surfaces, and rinse with the mouthwash. When going to bed, you are warned not to eat or drink (except water) as well as not brushing your teeth until the next day. On the following morning, approximately 12 hours after the last brushing and fasting, the first dental biofilm sample and unstimulated saliva is collected. It will be used to remove biofilm Hollenback vestibular faces, interproximal, palatal and lingual right hemiarch and deposited in a pre-weighed Eppendorf tube in an analytical balance. To saliva collection, the participant, at rest, will be instructed to spit for a minute in a graduated glass tube. After that, the participant will brush the occlusal surfaces for 1 min and rinse with 10 mL of the mouthwash for 1 min. Soon after, will new collection of saliva and plaque. Saliva samples will give up in times of 3, 15, 30, 45 and 60 minutes after brushing, while the biofilm left hemiarch will be collected one hour after brushing. After the collection will be offered at breakfast organized by researchers participating in the crown of that research center.
- Laboratorial phase Samples will be evaluated through physical-chemical analysis of fluoride using calibrated fluoride electrode. Samples will be analyzed for fluoride concentration using ion-specific electrode after diffusion facilitated with hexamethyl disiloxane (HMDS). The calibration curve is made for each analysis. All analyzes will be done in triplicate and be submitted for validation.
- Data analysis The study data will be analyzed by inferential statistics considering p <0.05.
- Conditions
- Dental Caries
- Being tested
- Mouthwash 100% Nano-F, Mouthwash 50% Nano-F, Mouthwash standard, Placebo
- Keywords
- Fluoride, Dental caries, Mouthwashes
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthwash 100% Nano-FOther
Use 10 ml of mouthwash 100% Nanoencapsulated Fluoride after brushing for one week, twice a day.
Mouthwash 50% Nano-FOther
Use 10 ml of mouthwash 50% Nanoencapsulated Fluoride after brushing for one week, twice a day.
Mouthwash standardOther
Use 10 ml of mothwash after brushing for one week, twice a day. It's for the positive control of fluoride.
PlaceboOther
Use 10 ml of mouthwash without fluoride
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Mouthwash without fluoride. Receives: Other: Placebo |
| Mouthwash standard | Active comparator | Mouthwash with 225ppm sodium fluoride (NaF). Positive control. Receives: Other: Mouthwash standard |
| Mouthwash 50% Nano-F | Experimental | Mouthwash experimental with Fluoride being half of fluoride Nanoencapsulated and other half freeform of NaF. Receives: Other: Mouthwash 50% Nano-F |
| Mouthwash 100% Nano-F | Experimental | Mouthwash experimental with fluoride 100% Nanoencapsulated. Receives: Other: Mouthwash 100% Nano-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of intraoral fluoride (biofilm and saliva) collection of dental plaque(biofilm) and saliva
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Nov 2016
- Primary completion15 Nov 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, triple-blind crossover clinical trial study was performed to evaluate the bioavailability of intraoral fluoride in biomarkers of exposure (biofilm and saliva) after the use of mouthwash with experimental fluoride for one week, with wash-out periods between them
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabio Correia Sampaio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabio Correia Sampaio, Federal University of Paraíba
- Investigators
- Fábio Sampaio, Study director, University Federal of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143086
- Sponsor's protocol ID
- NanoFMouthwash
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Buzalaf MA, Vilhena FV, Iano FG, Grizzo L, Pessan JP, Sampaio FC, Oliveira RC. The effect of different fluoride concentrations and pH of dentifrices on plaque and nail fluoride levels in young children. Caries Res. 2009;43(2):142-6. doi: 10.1159/000211717. Epub 2009 Apr 8.
PubMed 19365118Whitford GM, Wasdin JL, Schafer TE, Adair SM. Plaque fluoride concentrations are dependent on plaque calcium concentrations. Caries Res. 2002 Jul-Aug;36(4):256-65. doi: 10.1159/000063931.
PubMed 12218274Pessan JP, Silva SM, Lauris JR, Sampaio FC, Whitford GM, Buzalaf MA. Fluoride uptake by plaque from water and from dentifrice. J Dent Res. 2008 May;87(5):461-5. doi: 10.1177/154405910808700501.
PubMed 18434577Pessan JP, Pinto Alves KM, Italiani Fde M, Ramires I, Lauris JR, Whitford GM, Toumba KJ, Robinson C, Buzalaf MA. Distribution of fluoride and calcium in plaque biofilms after the use of conventional and low-fluoride dentifrices. Int J Paediatr Dent. 2014 Jul;24(4):293-302. doi: 10.1111/ipd.12073.
PubMed 25045768Pessan JP, Conceicao JM, Grizzo LT, Szekely M, Fazakas Z, Buzalaf MA. Intraoral fluoride levels after use of conventional and high-fluoride dentifrices. Clin Oral Investig. 2015 May;19(4):955-8. doi: 10.1007/s00784-015-1426-3. Epub 2015 Feb 14.
PubMed 25677244Duckworth RM, Jones S. On the relationship between the rate of salivary flow and salivary fluoride clearance. Caries Res. 2015;49(2):141-6. doi: 10.1159/000365949. Epub 2015 Jan 27.
PubMed 25634162Duckworth RM, Morgan SN, Gilbert RJ. Oral fluoride measurements for estimation of the anti-caries efficacy of fluoride treatments. J Dent Res. 1992 Apr;71 Spec No:836-40. doi: 10.1177/002203459207100S09.
PubMed 1592970
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation in Vivo of Experimental Mouthwash With Nanoencapsulated Fluoride
- ClinicalTrials.gov ID
- NCT05143086
- Acronym / sponsor ID
- NanoFMouthwash
- Conditions
- Dental Caries
- Keywords
- Fluoride, Dental caries, Mouthwashes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fabio Correia SampaioUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 3 Dec 2021 (actual)
- 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 literature recognizes that fluoride is the most widely used and studied means for dental remineralization. The use of fluoride mouthwashes is shown as an effective way to increase the fluoride intraoral availability. However, the current challenge is the substantivity, so new compounds have been introduced into these formulations. This study aims to evaluate the in vivo effect of fluoride mouthwash containing nanoencapsulated Fluoride (NanoF) - in fluoride retention in saliva and dental plaque. A study of the clinical and laboratory type, crossover, double-blind, randomized will be held. After sample calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed, missing, and filled teeth index less than 6 and residents in brazilian northeast capital will be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after rinsing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3 mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium fluoride. Between weeks of use, rinsing will be extended washout (without fluoride) to avoid carryover effect. Inferential data analysis will be carried out, considering the amount of alpha <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in the oral fluids promoted by the Nanoencapsulated Fluoride may have important impact on Des-Re process and in the control of dental caries.
Detailed description
- Study design It is a quantitative study of double-blind randomized crossover clinical type with inductive approach and documentation of technical and direct observation with measurements in the laboratory. In order to assess the bioavailability of intraoral fluoride week after the use of fluoride mouthwashes containing Nanoencapsulated Fluoride, it will be collected biofilm samples 1h and 12 h after rinse; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. The data will be obtained by physical and chemical analysis of the samples of fluoride (F). Therefore, the study will consist of two interrelated steps: a clinical phase for biofilm collection and saliva; and laboratory stage for fluoride analysis in the samples. Will be conducted pilot test with three participants before the start of the study.
- Sample Size The sample size calculation was performed using fluoride concentration data in dental biofilm previous study and taking effect size difference between the experimental mouthwash (100% Nanoencapsulated Fluoride ) and positive control of at least 3.4 ppm of F- in biofilm after 12 hours, namely, 25%. Admitting experimental protocol with beta error of 10% alpha error of 5%, one-tailed and statistical power of 90%, the sample size was calculated for 6 people. For the calculation we used the Excel software and mathematical formula for clinical trials of superiority given. Adding sample loss resulted in 12 people.
- Experimental Mouthwash For this study will be used four mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride, Free sodium fluoride, Without fluoride. The mouthwash, made available by the company from Brazil are packed in the same packaging and have the taste of mint. Except wash out the packing with mouthwash will be identified by letters (A, B and C) by an independent researcher. The letters code will not be revealed to the participants nor the researcher who will accompany them. These will be drawn at random for daily use for seven days in four times, giving an interval of one week wash-out between them. In these periods of wash-out will use a mouthwash without fluoride. In the end, all study participants will use the 5 experimental mouthwash at different times. A dentifrice without fluoride will be used by the participant during the study.
- Clinical phase The participant will be informed about the study and after its acceptance, he/she will initiate the study. Initially will be clinical examination in order to report the presence of any of the exclusion criteria already listed. After verifying the absence of these criteria, there will be a dental prophylaxis pumice for removal of this biofilm and in some cases may be made supragingival scraping. The patient will be advised not to make use of any fluoride product during the experiment. At first, volunteers are instructed to use a mouthwash without fluoride (wash out) the first week, in order to equate the study participants and eliminate any potential carryover effects of toothpaste or mouthwash used previously. The participant will get a packing of mouthwash and will be instructed to brush their teeth for 1 minute with the dentifrice without fluoride and rinse with 10 mL of mouthwash for 1 min twice a day (morning and night). On the seventh day, the participant will be instructed to brush only the occlusal surfaces of your teeth, to allow biofilm accumulation of flat surfaces, and rinse with the mouthwash. When going to bed, you are warned not to eat or drink (except water) as well as not brushing your teeth until the next day. On the following morning, approximately 12 hours after the last brushing and fasting, the first dental biofilm sample and unstimulated saliva is collected. It will be used to remove biofilm Hollenback vestibular faces, interproximal, palatal and lingual right hemiarch and deposited in a pre-weighed Eppendorf tube in an analytical balance. To saliva collection, the participant, at rest, will be instructed to spit for a minute in a graduated glass tube. After that, the participant will brush the occlusal surfaces for 1 min and rinse with 10 mL of the mouthwash for 1 min. Soon after, will new collection of saliva and plaque. Saliva samples will give up in times of 3, 15, 30, 45 and 60 minutes after brushing, while the biofilm left hemiarch will be collected one hour after brushing. After the collection will be offered at breakfast organized by researchers participating in the crown of that research center.
- Laboratorial phase Samples will be evaluated through physical-chemical analysis of fluoride using calibrated fluoride electrode. Samples will be analyzed for fluoride concentration using ion-specific electrode after diffusion facilitated with hexamethyl disiloxane (HMDS). The calibration curve is made for each analysis. All analyzes will be done in triplicate and be submitted for validation.
- Data analysis The study data will be analyzed by inferential statistics considering p <0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- A randomized, triple-blind crossover clinical trial study was performed to evaluate the bioavailability of intraoral fluoride in biomarkers of exposure (biofilm and saliva) after the use of mouthwash with experimental fluoride for one week, with wash-out periods between them
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboMouthwash without fluoride. |
| Mouthwash standard | Active comparator | Other: Mouthwash standardMouthwash with 225ppm sodium fluoride (NaF). Positive control. |
| Mouthwash 50% Nano-F | Experimental | Other: Mouthwash 50% Nano-FMouthwash experimental with Fluoride being half of fluoride Nanoencapsulated and other half freeform of NaF. |
| Mouthwash 100% Nano-F | Experimental | Other: Mouthwash 100% Nano-FMouthwash experimental with fluoride 100% Nanoencapsulated. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- resident in João Pessoa;
- Decayed, Missing, Filled Index<6;
- Healthy
Key exclusion criteria (7 listed)
- orthodontic treatment;
- gingivitis;
- Periodontal disease;
- Smokers;
- Present active tooth decay;
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 |
|---|---|---|
| Mouthwash 100% Nano-FUse 10 ml of mouthwash 100% Nanoencapsulated Fluoride after brushing for one week, twice a day. | Other | Mouthwash 100% Nano-F |
| Mouthwash 50% Nano-FUse 10 ml of mouthwash 50% Nanoencapsulated Fluoride after brushing for one week, twice a day. | Other | Mouthwash 50% Nano-F |
| Mouthwash standardUse 10 ml of mothwash after brushing for one week, twice a day. It's for the positive control of fluoride. | Other | Mouthwash standard |
| PlaceboUse 10 ml of mouthwash without fluoride | Other | Placebo |
Primary outcome
Bioavailability of intraoral fluoride (biofilm and saliva) collection of dental plaque(biofilm) and saliva
Time frame: six 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 3 Dec 2021.
- Results publication: PubMed 19365118Buzalaf MA, Vilhena FV, Iano FG, Grizzo L, Pessan JP, Sampaio FC, Oliveira RC. The effect of different fluoride concentrations and pH of dentifrices on plaque and nail fluoride levels in young children. Caries Res. 2009;43(2):142-6. doi: 10.1159/000211717. Epub 2009 Apr 8.
- Results publication: PubMed 12218274Whitford GM, Wasdin JL, Schafer TE, Adair SM. Plaque fluoride concentrations are dependent on plaque calcium concentrations. Caries Res. 2002 Jul-Aug;36(4):256-65. doi: 10.1159/000063931.
- Results publication: PubMed 18434577Pessan JP, Silva SM, Lauris JR, Sampaio FC, Whitford GM, Buzalaf MA. Fluoride uptake by plaque from water and from dentifrice. J Dent Res. 2008 May;87(5):461-5. doi: 10.1177/154405910808700501.
- Results publication: PubMed 25045768Pessan JP, Pinto Alves KM, Italiani Fde M, Ramires I, Lauris JR, Whitford GM, Toumba KJ, Robinson C, Buzalaf MA. Distribution of fluoride and calcium in plaque biofilms after the use of conventional and low-fluoride dentifrices. Int J Paediatr Dent. 2014 Jul;24(4):293-302. doi: 10.1111/ipd.12073.
- Results publication: PubMed 25677244Pessan JP, Conceicao JM, Grizzo LT, Szekely M, Fazakas Z, Buzalaf MA. Intraoral fluoride levels after use of conventional and high-fluoride dentifrices. Clin Oral Investig. 2015 May;19(4):955-8. doi: 10.1007/s00784-015-1426-3. Epub 2015 Feb 14.
- Results publication: PubMed 25634162Duckworth RM, Jones S. On the relationship between the rate of salivary flow and salivary fluoride clearance. Caries Res. 2015;49(2):141-6. doi: 10.1159/000365949. Epub 2015 Jan 27.
- Results publication: PubMed 1592970Duckworth RM, Morgan SN, Gilbert RJ. Oral fluoride measurements for estimation of the anti-caries efficacy of fluoride treatments. J Dent Res. 1992 Apr;71 Spec No:836-40. doi: 10.1177/002203459207100S09.
- Individual participant dataSharing planned: Yes
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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.
Fábio Sampaio study director
University Federal of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mouthwash 100% Nano-F, Mouthwash 50% Nano-F and Mouthwash standard in people with Dental Caries, run by Fabio Correia Sampaio 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 7 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 3 Dec 2021. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Bioavailability of intraoral fluoride (biofilm and saliva) collection of dental plaque(biofilm) and saliva (time frame: six 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 NCT05143086, which also lists 7 linked publications.
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 3 Dec 2021.