Root CariesNCT04432415
Comparison of Silver Diamine Fluoride and Sodium Fluoride Varnish to Prevent and Arrest Root Caries in Older Adults
A study testing Silver Diamine Fluoride and Soduim Fluoride Varnish in people with Root Caries, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
Dental caries (coronal and root) is highly prevalent in older adults. It is important to identify and implement the most effective methods that prevent the formation of root caries lesions and inhibit existing lesions at the community level. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Caries
- What is being tested?
- Silver Diamine Fluoride and Soduim Fluoride Varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2017to Dec 2021
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 60 years of age and older
- At least 5 teeth with gingival recession and exposed root surfaces not indicated for extraction
- No problems performing activities of daily living
- Agree to participate and sign the informed consent.
Who cannot join
- Health problems that prevent oral hygiene
- Cognitive problems that prevent understanding oral hygiene instructions
- Salivary gland diseases (hyposalivation)
- Having received radiation therapy to the head and neck
- Deafness
- Active infections of the oral mucosa
Show all 11Show fewer
- Allergy to silver
- Stomatitis
- Allergy to colophony (component of varnishes)
- Elimination criteria:
- -Adults who do not return to subsequent applications of silver diamine fluoride, sodium fluoride varnish, or artificial saliva.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Silver Diamine Fluoride Solution and Sodium Fluoride Varnish for the Prevention and Arrest of Root Caries in a Group of Older Adults
Dental caries (coronal and root) is highly prevalent in older adults. It is important to identify and implement the most effective methods that prevent the formation of root caries lesions and inhibit existing lesions at the community level.
A clinical trial will be conducted in three groups of adults 60 years old and older, comparing the application of silver diamine fluoride solution and sodium fluoride varnish in dental root surfaces with caries and sound root surfaces. The objectives are to determine over a 30-month period which of the two agents is most effective in reducing the incidence of root caries, and which is most effective in arresting active root caries lesions.
Read more
Hypothesis: the incidence of root caries will be lower in the group of subjects treated with silver diamine fluoride compared to sodium fluoride varnish. The arrest of active root lesions will be higher when using silver diamine fluoride compared to sodium fluoride varnish.
Signed informed consent will be requested from persons 60 years and over, residents of four long-term care centers and attendees of a day care center in four central states of Mexico: Mexico City, Cuernavaca City, Oaxaca City and Toluca City. All facilities are administered by the National System for Integral Family Development (IFD), a public welfare institution that works at the federal and state levels.
Three groups will be formed (60 participants in each), two groups will be administered each of the agents, the third group will be the control group. All groups will receive dental health education (oral hygiene, instructions for care and hygiene of removable dental prosthesis, information on prevention of coronal and root caries and periodontal diseases). The preventive agents will be administered according to the manufacturer's instructions. Clinical evaluations will be carried out at baseline 6, 12, 18, 24 and 30 months. The incidence of root caries among the groups will be compared with the percentage of active root lesions that were arrested and that remained inactive.
If the greater efficacy of silver diamine fluoride is proven, it can be proposed for use in caries preventive programs for older persons, reducing the risk of tooth loss and improving quality of life. It will also serve as a guide for dental surgeon in-office decision-making regarding the method to use to prevent and limit root caries lesions in older adults at risk.
Read the detailed description
There is an increase in the incidence and prevalence of chronic diseases, including oral problems in older persons. Coronal and root caries, and periodontitis represent the main causes of tooth loss, and in older adults they have a great impact on quality of life, nutritional status, social life, and the increased risk of systemic problems related to dental infectious processes. At present, older adults have more remaining teeth and dental caries is highly prevalent. It is important to investigate and implement methods that prevent the formation of new carious lesions and that arrest existing lesions. The utilization of silver diamine fluoride as a method to prevent coronal caries has been recognized and has proven to be highly effective in treating dentin hypersensitivity and arresting active lesions, also it is easy to apply. Therefore, it is important and necessary to implement methods that avoid the formation of lesions and that inhibit the root caries lesions already present.
If greater effectiveness of silver diamine fluoride in preventing and arresting active root caries is confirmed, its use in conjunction with oral health education can be proposed as a preventive method to be included in oral health programs in institutionalized persons in whom dental care and attention are less frequent. Its ease of application, the longer time between applications and its cost can facilitate better oral care. On the other hand, the results can guide professionals in clinical practice in making decisions regarding the most appropriate method to prevent and arrest root caries lesions in their patients.
Hypothesis The incidence of root caries (new root caries lesions) after 30 months will be lower on root surfaces that have been treated with silver diamine fluoride solution (38% concentration [44800 ppm]) compared to those treated with sodium fluoride varnish (5% concentration [22,600 ppm]) and to those in the control group (artificial saliva).
The number of active root caries lesions arrested at baseline will be higher in people who have been treated with silver diamine fluoride solution (38% concentration [44,800 ppm]) compared to those treated with sodium fluoride varnish (5% concentration [22600 ppm]) and with the control group (artificial saliva).
General objective:
To identify whether the annual application of silver diamine fluoride solution combined with an individualized oral health education program is more effective than biannual application of sodium fluoride varnish combined with an individualized oral health education program and a group control (artificial saliva and oral health individualized educational program) in the reduction of the incidence of root caries and in the arrest of active root caries lesions over a period of 30 months in a population of adults over 60 years of age in residents of 4 gerontological centers and a DIF day care center, in 2017-2020.
Specific objectives:
- To compare the incidence of root caries after 30 months in three groups receiving the annual application of silver diamine fluoride solution (44800 ppm), the biannual application of sodium fluoride varnish (22600 ppm) and the biannual application of artificial saliva respectively, controlling for age, gender, frequency of toothbrushing, use of dental floss, use of removable prostheses.
- To compare the number of active root carious lesions arrested at baseline after annual application of silver diamine fluoride solution (44,800 ppm) and biannual application of sodium fluoride varnish (22,600 ppm) and biannual application of artificial saliva, all combined with an individualized oral health education program, controlling by age, gender, frequency of toothbrushing, use of dental floss, use of removable prostheses.
- To design and implement an individualized oral health education program on prevention and treatment of root and coronal caries, promotion and reinforcement of toothbrushing, and the proper care and cleaning of removable prostheses.
METHODS Area: clinical research Study type: Intervention Study design: randomized controlled clinical trial. Study characteristics: prospective, longitudinal, comparative. Participant allocation: randomized Study classification: efficacy study Intervention model: parallel groups Masking: blind (participant) Main purpose: Prevention Study population Residents of four gerontological centers "Arturo Mundet" (Mexico City), "Vicente García Torres" (Mexico City), "Los Tamayo" (Oaxaca, Oaxaca) and "Olga Tamayo" (Cuernavaca, Morelos ) and a day care center in Santa Ana Tlapaltitlán (Toluca, State of Mexico). All centers are administered by the National System for Integral Family Development, a public welfare institution that works at the federal and state levels.
Sample size Three groups of size 60 are required, in a no probabilistic convenience sampling.
The administration will be carried out in the same way in the three groups using a mini applicator brush.
Control group: biannual application of artificial saliva on exposed root surfaces. Sodium Fluoride varnish: biannual application of sodium fluoride varnish (22,600 ppm) on exposed healthy root surfaces and application at baseline and biannually on active root lesions. Silver Diamine Fluoride: annual application of silver diamine fluoride solution (44800ppm) on exposed healthy root surfaces and alternate annual application of artificial saliva, as well as initial and annual application on active root lesions.
Before data collection persons will be invited to participate, the purpose of the study will be explained, and if they accept will be examined to identify whether they meet the selection criteria.
Once the participants have been selected and signed the informed consent, they will be randomly assigned to one of the three groups. The baseline questionnaire on knowledge, attitudes and practices, the clinical evaluation and the initial application of the preventive agents or placebo, and the first personalized oral health education session will be carried out.The clinical examination will be carried out in each center using a portable dental unit and artificial light.
The evaluations will be repeated at 6, 12, 18, 24 and 30 months. The examiner will be standardized for the evaluation of root caries using the International Caries Detection and Assessment System (ICDAS) for root caries, and in the assessment of dental plaque and dental calculus.
- Conditions
- Root Caries
- Being tested
- Silver Diamine Fluoride, Soduim Fluoride Varnish, Placebo
- Keywords
- root caries, Fluorides, aged, incidence, Mexico, Long-Term Care
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDevice
Annual application od Silver Diamine Fluoride
Soduim Fluoride VarnishDevice
biannual apllication of Sodium Fluoride Varnish
PlaceboDevice
biannual application of artificial saliva
| Study group | Role | What they receive |
|---|---|---|
| Group Silver Diamine Fluoride | Experimental | Participants receive Annual applications of 38% SDF solution and semestral applications of artificial saliva and a personalized dental health education program. Receives: Device: Silver Diamine Fluoride |
| Group Sodium Fluoride Varnish | Experimental | Participants receive semestral applications of Sodium Varnish Fluoride and a personalized dental health education program. Receives: Device: Soduim Fluoride Varnish |
| Placebo | Placebo comparator | Participants receive semestral apllications of artificial saliva and a personalized dental health education program. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of root caries lesions
Number of new caries lesions
Measured: 30 months
Secondary outcomes (1)
Arrested root caries lesions
number of active root caries lesions arrested (non active)
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Sep 2017
- Primary completion31 Jul 2019
- Study completionDec 2021 (estimated)
Why it stopped: Coronavirus Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Root 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned randomly into treatment and control group using a randomization protocol.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Sistema para el Desarrollo Integral de la Familia
- Responsible party
- Principal investigator, Aida Borges, Universidad Nacional Autonoma de Mexico
- Investigators
- Aida Borges-Yañez, PhD, Principal investigator, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432415
- Sponsor's protocol ID
- UNAMexico CIE/0810/03/2017
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deutsch A. An alternate technique of care using silver fluoride followed by stannous fluoride in the management of root caries in aged care. Spec Care Dentist. 2016 Mar-Apr;36(2):85-92. doi: 10.1111/scd.12153. Epub 2015 Dec 21.
PubMed 26687774Tan HP, Lo EC, Dyson JE, Luo Y, Corbet EF. A randomized trial on root caries prevention in elders. J Dent Res. 2010 Oct;89(10):1086-90. doi: 10.1177/0022034510375825. Epub 2010 Jul 29.
PubMed 20671206Zhang W, McGrath C, Lo EC, Li JY. Silver diamine fluoride and education to prevent and arrest root caries among community-dwelling elders. Caries Res. 2013;47(4):284-90. doi: 10.1159/000346620. Epub 2013 Feb 5.
PubMed 23392087Sequeira-Byron P, Lussi A. Prevention of root caries. Evid Based Dent. 2011;12(3):70-1. doi: 10.1038/sj.ebd.6400805.
PubMed 21979764Richards D. Fluoride has a beneficial effect on root caries. Evid Based Dent. 2009;10(1):12. doi: 10.1038/sj.ebd.6400627.
PubMed 19322220Twetman S, Keller MK. Fluoride Rinses, Gels and Foams: An Update of Controlled Clinical Trials. Caries Res. 2016;50 Suppl 1:38-44. doi: 10.1159/000439180. Epub 2016 Apr 22.
PubMed 27101002
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Silver Diamine Fluoride Solution and Sodium Fluoride Varnish for the Prevention and Arrest of Root Caries in a Group of Older Adults
- ClinicalTrials.gov ID
- NCT04432415
- Acronym / sponsor ID
- UNAMexico CIE/0810/03/2017
- Conditions
- Root Caries
- Keywords
- root caries, Fluorides, aged, incidence, Mexico, Long-Term Care
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Coronavirus Pandemic
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- Sistema para el Desarrollo Integral de la Familia
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Jun 2020 (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.
Dental caries (coronal and root) is highly prevalent in older adults. It is important to identify and implement the most effective methods that prevent the formation of root caries lesions and inhibit existing lesions at the community level.
A clinical trial will be conducted in three groups of adults 60 years old and older, comparing the application of silver diamine fluoride solution and sodium fluoride varnish in dental root surfaces with caries and sound root surfaces. The objectives are to determine over a 30-month period which of the two agents is most effective in reducing the incidence of root caries, and which is most effective in arresting active root caries lesions.
Hypothesis: the incidence of root caries will be lower in the group of subjects treated with silver diamine fluoride compared to sodium fluoride varnish. The arrest of active root lesions will be higher when using silver diamine fluoride compared to sodium fluoride varnish.
Signed informed consent will be requested from persons 60 years and over, residents of four long-term care centers and attendees of a day care center in four central states of Mexico: Mexico City, Cuernavaca City, Oaxaca City and Toluca City. All facilities are administered by the National System for Integral Family Development (IFD), a public welfare institution that works at the federal and state levels.
Three groups will be formed (60 participants in each), two groups will be administered each of the agents, the third group will be the control group. All groups will receive dental health education (oral hygiene, instructions for care and hygiene of removable dental prosthesis, information on prevention of coronal and root caries and periodontal diseases). The preventive agents will be administered according to the manufacturer's instructions. Clinical evaluations will be carried out at baseline 6, 12, 18, 24 and 30 months. The incidence of root caries among the groups will be compared with the percentage of active root lesions that were arrested and that remained inactive.
If the greater efficacy of silver diamine fluoride is proven, it can be proposed for use in caries preventive programs for older persons, reducing the risk of tooth loss and improving quality of life. It will also serve as a guide for dental surgeon in-office decision-making regarding the method to use to prevent and limit root caries lesions in older adults at risk.
Detailed description
There is an increase in the incidence and prevalence of chronic diseases, including oral problems in older persons. Coronal and root caries, and periodontitis represent the main causes of tooth loss, and in older adults they have a great impact on quality of life, nutritional status, social life, and the increased risk of systemic problems related to dental infectious processes. At present, older adults have more remaining teeth and dental caries is highly prevalent. It is important to investigate and implement methods that prevent the formation of new carious lesions and that arrest existing lesions. The utilization of silver diamine fluoride as a method to prevent coronal caries has been recognized and has proven to be highly effective in treating dentin hypersensitivity and arresting active lesions, also it is easy to apply. Therefore, it is important and necessary to implement methods that avoid the formation of lesions and that inhibit the root caries lesions already present.
If greater effectiveness of silver diamine fluoride in preventing and arresting active root caries is confirmed, its use in conjunction with oral health education can be proposed as a preventive method to be included in oral health programs in institutionalized persons in whom dental care and attention are less frequent. Its ease of application, the longer time between applications and its cost can facilitate better oral care. On the other hand, the results can guide professionals in clinical practice in making decisions regarding the most appropriate method to prevent and arrest root caries lesions in their patients.
Hypothesis The incidence of root caries (new root caries lesions) after 30 months will be lower on root surfaces that have been treated with silver diamine fluoride solution (38% concentration [44800 ppm]) compared to those treated with sodium fluoride varnish (5% concentration [22,600 ppm]) and to those in the control group (artificial saliva).
The number of active root caries lesions arrested at baseline will be higher in people who have been treated with silver diamine fluoride solution (38% concentration [44,800 ppm]) compared to those treated with sodium fluoride varnish (5% concentration [22600 ppm]) and with the control group (artificial saliva).
General objective:
To identify whether the annual application of silver diamine fluoride solution combined with an individualized oral health education program is more effective than biannual application of sodium fluoride varnish combined with an individualized oral health education program and a group control (artificial saliva and oral health individualized educational program) in the reduction of the incidence of root caries and in the arrest of active root caries lesions over a period of 30 months in a population of adults over 60 years of age in residents of 4 gerontological centers and a DIF day care center, in 2017-2020.
Specific objectives:
- To compare the incidence of root caries after 30 months in three groups receiving the annual application of silver diamine fluoride solution (44800 ppm), the biannual application of sodium fluoride varnish (22600 ppm) and the biannual application of artificial saliva respectively, controlling for age, gender, frequency of toothbrushing, use of dental floss, use of removable prostheses.
- To compare the number of active root carious lesions arrested at baseline after annual application of silver diamine fluoride solution (44,800 ppm) and biannual application of sodium fluoride varnish (22,600 ppm) and biannual application of artificial saliva, all combined with an individualized oral health education program, controlling by age, gender, frequency of toothbrushing, use of dental floss, use of removable prostheses.
- To design and implement an individualized oral health education program on prevention and treatment of root and coronal caries, promotion and reinforcement of toothbrushing, and the proper care and cleaning of removable prostheses.
METHODS Area: clinical research Study type: Intervention Study design: randomized controlled clinical trial. Study characteristics: prospective, longitudinal, comparative. Participant allocation: randomized Study classification: efficacy study Intervention model: parallel groups Masking: blind (participant) Main purpose: Prevention Study population Residents of four gerontological centers "Arturo Mundet" (Mexico City), "Vicente García Torres" (Mexico City), "Los Tamayo" (Oaxaca, Oaxaca) and "Olga Tamayo" (Cuernavaca, Morelos ) and a day care center in Santa Ana Tlapaltitlán (Toluca, State of Mexico). All centers are administered by the National System for Integral Family Development, a public welfare institution that works at the federal and state levels.
Sample size Three groups of size 60 are required, in a no probabilistic convenience sampling.
The administration will be carried out in the same way in the three groups using a mini applicator brush.
Control group: biannual application of artificial saliva on exposed root surfaces. Sodium Fluoride varnish: biannual application of sodium fluoride varnish (22,600 ppm) on exposed healthy root surfaces and application at baseline and biannually on active root lesions. Silver Diamine Fluoride: annual application of silver diamine fluoride solution (44800ppm) on exposed healthy root surfaces and alternate annual application of artificial saliva, as well as initial and annual application on active root lesions.
Before data collection persons will be invited to participate, the purpose of the study will be explained, and if they accept will be examined to identify whether they meet the selection criteria.
Once the participants have been selected and signed the informed consent, they will be randomly assigned to one of the three groups. The baseline questionnaire on knowledge, attitudes and practices, the clinical evaluation and the initial application of the preventive agents or placebo, and the first personalized oral health education session will be carried out.The clinical examination will be carried out in each center using a portable dental unit and artificial light.
The evaluations will be repeated at 6, 12, 18, 24 and 30 months. The examiner will be standardized for the evaluation of root caries using the International Caries Detection and Assessment System (ICDAS) for root caries, and in the assessment of dental plaque and dental calculus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be assigned randomly into treatment and control group using a randomization protocol.
| Arm | Type | Receives |
|---|---|---|
| Group Silver Diamine Fluoride | Experimental | Device: Silver Diamine FluorideParticipants receive Annual applications of 38% SDF solution and semestral applications of artificial saliva and a personalized dental health education program. |
| Group Sodium Fluoride Varnish | Experimental | Device: Soduim Fluoride VarnishParticipants receive semestral applications of Sodium Varnish Fluoride and a personalized dental health education program. |
| Placebo | Placebo comparator | Device: PlaceboParticipants receive semestral apllications of artificial saliva and a personalized dental health education program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 60 years of age and older
- At least 5 teeth with gingival recession and exposed root surfaces not indicated for extraction
- No problems performing activities of daily living
- Agree to participate and sign the informed consent.
Key exclusion criteria (11 listed)
- Health problems that prevent oral hygiene
- Cognitive problems that prevent understanding oral hygiene instructions
- Salivary gland diseases (hyposalivation)
- Having received radiation therapy to the head and neck
- Deafness
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 |
|---|---|---|
| Silver Diamine FluorideAnnual application od Silver Diamine Fluoride | Device | Group Silver Diamine Fluoride |
| Soduim Fluoride Varnishbiannual apllication of Sodium Fluoride Varnish | Device | Group Sodium Fluoride Varnish |
| Placebobiannual application of artificial saliva | Device | Placebo |
Primary outcome
Incidence of root caries lesions
Time frame: 30 months
Number of new caries lesions
1 secondary outcome
Arrested root caries lesions
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 26687774Deutsch A. An alternate technique of care using silver fluoride followed by stannous fluoride in the management of root caries in aged care. Spec Care Dentist. 2016 Mar-Apr;36(2):85-92. doi: 10.1111/scd.12153. Epub 2015 Dec 21.
- Background: PubMed 20671206Tan HP, Lo EC, Dyson JE, Luo Y, Corbet EF. A randomized trial on root caries prevention in elders. J Dent Res. 2010 Oct;89(10):1086-90. doi: 10.1177/0022034510375825. Epub 2010 Jul 29.
- Background: PubMed 23392087Zhang W, McGrath C, Lo EC, Li JY. Silver diamine fluoride and education to prevent and arrest root caries among community-dwelling elders. Caries Res. 2013;47(4):284-90. doi: 10.1159/000346620. Epub 2013 Feb 5.
- Background: PubMed 21979764Sequeira-Byron P, Lussi A. Prevention of root caries. Evid Based Dent. 2011;12(3):70-1. doi: 10.1038/sj.ebd.6400805.
- Background: PubMed 19322220Richards D. Fluoride has a beneficial effect on root caries. Evid Based Dent. 2009;10(1):12. doi: 10.1038/sj.ebd.6400627.
- Background: PubMed 27101002Twetman S, Keller MK. Fluoride Rinses, Gels and Foams: An Update of Controlled Clinical Trials. Caries Res. 2016;50 Suppl 1:38-44. doi: 10.1159/000439180. Epub 2016 Apr 22.
- Individual participant dataSharing planned: No
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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.
Aida Borges-Yañez, PhD principal investigator
Universidad Nacional Autonoma de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride and Soduim Fluoride Varnish in people with Root Caries, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
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 11 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: paused, as of the sponsor's last update on 16 Jun 2020. 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 Mexico. 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.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of root caries lesions (time frame: 30 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 NCT04432415, which also lists 6 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 16 Jun 2020.