Root CariesPhase 1/2MIT-RCTalcaNCT02647203
Non-invasive Treatment of Root Caries in Older Adults
A Phase 1/2 study testing Self-administered fluoridated dentifrices in people with Root Caries, run by University of Talca at 1 site in Chile.
Trial summary
This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. 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?
- Self-administered fluoridated dentifrices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteChile
- Study dates
- Jul 2014to 21 Dec 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 60 + years old
- community-dwelling
- living in a community with fluoridated water
- had five or more of their own teeth
- with ≥ 1 root caries lesion
Who cannot join
- cognitive impairment
- alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults
This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will be delivered to the participants in a blind format and they will be instructed to brush twice per day.
Follow-up will be carries out every 6 months for two years to assess:
- Root caries incidence.
- Lesion arresting
- Changes in salivary flow
- Microbiology pattern shift
- Variations in oral health- related quality of life by OHIP-14 Sp
Read the detailed description
Background. Caries of the root surface (root caries) is the most prevalent type of dental caries in older adults with a reportedly worrisome trend to increase, as more teeth are being retained. Dental caries is the leading causes of tooth loss among older adults. Fluoride has been successfully used in preventive programs for root caries. In addition to preventing root caries, fluoride-based therapies may be used to treat lesions. This approach is known as non-invasive treatment. Fluoride seems to arrest and promote remineralization of the lesions. Indeed, recent studies appear to indicate that, higher fluoride concentrations are more effective to prevent and to treat the disease. Dentifrices with high concentrations of fluoride appear to be the most rational approach to prevent and treat root caries. To the chemical effect of fluoride, toothbrushing adds mechanical removal of the dental biofilm. High concentration fluoride varnishes have also been proposed as effective in treating carious lesions. Whether dentifrices, varnishes or the combined use of varnish and fluoridated toothpaste result more effective is a matter of controversy and it needs to be elucidated. Non-invasive treatment avoids the complications inherent to treating frail people in a dental setting, decrease costs and importantly, allows increased coverage, as these therapies may be delivered by non-dentist personnel. Although the appealing idea of non-invasive treatment of root caries in older adults, evidence is still limited and more research appears necessary to both, confirm clinical success and elucidate the mechanisms involved in lesion arrestment.
Aim. To determine the effectiveness of non-invasive therapies for root caries and their impact in the quality of life of older adults.
Methodology. A double blind randomized controlled trial (RCT) on independently-living older adults aged sixty or more years is proposed. Subjects will undergo clinical and microbiological examination when recruited (baseline) with a six-month follow-up regime until completion of two years. To participate, subjects will have to have at least five teeth with exposed root surfaces and one carious lesion. Sample size was calculated and a sample of two-hundred and eighty-eight older adults is necessary, randomized into two study arms;
Group 1: toothpaste 1.450 ppm F-
Group 2: toothpaste 5.000 ppm F-
Dependent variables. Root caries incidence and activity, cariogenic bacteria and oral health-related quality of life will be assessed upon completion of the study and compared with baseline scores.
Expected results. Based on some previous data available, it is expected that a non-invasive therapy for root caries based on low-fluoride concentration will be less effective than high fluoride therapies in inactivating root caries lesions. These results may be used in novel therapeutic programs at the community level, as well as in private practice. Furthermore, these studies will shed light on potential mechanisms associated with non-invasive treatment of root caries, from a microbiology stand point. Since a non-invasive approach decreases costs and increases coverage of dental care for older adults, these results may contribute to increase access to care for the usually vulnerable population of older adults.
- Conditions
- Root Caries
- Being tested
- Self-administered fluoridated dentifrices
- Keywords
- Fluoride toothpaste, Root caries, Randomized clinical trial
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered fluoridated dentifricesDrug
Also called Toothbrushing with high and standard fluoride dentifrices
Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
| Study group | Role | What they receive |
|---|---|---|
| High Fluoride Toothpaste | Experimental | 5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo) Receives: Drug: Self-administered fluoridated dentifrices |
| Standard Fluoride Toothpaste | Active comparator | 1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo) Receives: Drug: Self-administered fluoridated dentifrices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Caries Activity
Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.
Measured: After 2 years of follow up
Secondary outcomes (2)
Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)
The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group. In a scale ranging from 0 to 56 points, with 0-14 being good Oral Health-related quality of life and 15-56 poor Oral Health-related quality of life.
Measured: Data registered at 2 years of follow-up
Salivary Flow
Unstimulated Salivary Flow, defined as Normal or Low Important: This outcome measure was originally considered. However, due to logistic issues, we did not assess it and no data is available.
Measured: Baseline and 2-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJul 2014
- Primary completionNov 2016
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Talca
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Rodrigo A. Giacaman, DDS, PhD, University of Talca
- Investigators
- Rodrigo A Giacaman, DDS, PhD, Principal investigator, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647203
- Sponsor's protocol ID
- NI-RC PIEI-ES
- Other IDs
- 1140623
- Acronym
- MIT-RCTalca
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2015
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ekstrand K, Martignon S, Holm-Pedersen P. Development and evaluation of two root caries controlling programmes for home-based frail people older than 75 years. Gerodontology. 2008 Jun;25(2):67-75. doi: 10.1111/j.1741-2358.2007.00200.x. Epub 2008 Jan 13.
PubMed 18194330Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. A randomized clinical trial of the anti-caries efficacy of 5,000 compared to 1,450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Caries Res. 2013;47(5):391-8. doi: 10.1159/000348581. Epub 2013 Apr 9.
PubMed 23594784Gluzman R, Katz RV, Frey BJ, McGowan R. Prevention of root caries: a literature review of primary and secondary preventive agents. Spec Care Dentist. 2013 May-Jun;33(3):133-40. doi: 10.1111/j.1754-4505.2012.00318.x. Epub 2012 Dec 10.
PubMed 23600985Griffin SO, Griffin PM, Swann JL, Zlobin N. Estimating rates of new root caries in older adults. J Dent Res. 2004 Aug;83(8):634-8. doi: 10.1177/154405910408300810.
PubMed 15271973Griffin SO, Regnier E, Griffin PM, Huntley V. Effectiveness of fluoride in preventing caries in adults. J Dent Res. 2007 May;86(5):410-5. doi: 10.1177/154405910708600504.
PubMed 17452559Holmgren C, Gaucher C, Decerle N, Domejean S. Minimal intervention dentistry II: part 3. Management of non-cavitated (initial) occlusal caries lesions--non-invasive approaches through remineralisation and therapeutic sealants. Br Dent J. 2014 Mar;216(5):237-43. doi: 10.1038/sj.bdj.2014.147.
PubMed 24603245Ritter AV, Shugars DA, Bader JD. Root caries risk indicators: a systematic review of risk models. Community Dent Oral Epidemiol. 2010 Oct;38(5):383-97. doi: 10.1111/j.1600-0528.2010.00551.x.
PubMed 20545716Walls AW, Meurman JH. Approaches to caries prevention and therapy in the elderly. Adv Dent Res. 2012 Sep;24(2):36-40. doi: 10.1177/0022034512453590.
PubMed 22899677Leon S, Bravo-Cavicchioli D, Correa-Beltran G, Giacaman RA. Validation of the Spanish version of the Oral Health Impact Profile (OHIP-14Sp) in elderly Chileans. BMC Oral Health. 2014 Aug 4;14:95. doi: 10.1186/1472-6831-14-95.
PubMed 25091189Leon S, Gonzalez K, Hugo FN, Gambetta-Tessini K, Giacaman RA. High fluoride dentifrice for preventing and arresting root caries in community-dwelling older adults: A randomized controlled clinical trial. J Dent. 2019 Jul;86:110-117. doi: 10.1016/j.jdent.2019.06.002. Epub 2019 Jun 6.
PubMed 31176788
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults
- ClinicalTrials.gov ID
- NCT02647203
- Acronym / sponsor ID
- MIT-RCTalca / NI-RC PIEI-ES
- Conditions
- Root Caries
- Keywords
- Fluoride toothpaste, Root caries, Randomized clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Jul 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will be delivered to the participants in a blind format and they will be instructed to brush twice per day.
Follow-up will be carries out every 6 months for two years to assess:
- Root caries incidence.
- Lesion arresting
- Changes in salivary flow
- Microbiology pattern shift
- Variations in oral health- related quality of life by OHIP-14 Sp
Detailed description
Background. Caries of the root surface (root caries) is the most prevalent type of dental caries in older adults with a reportedly worrisome trend to increase, as more teeth are being retained. Dental caries is the leading causes of tooth loss among older adults. Fluoride has been successfully used in preventive programs for root caries. In addition to preventing root caries, fluoride-based therapies may be used to treat lesions. This approach is known as non-invasive treatment. Fluoride seems to arrest and promote remineralization of the lesions. Indeed, recent studies appear to indicate that, higher fluoride concentrations are more effective to prevent and to treat the disease. Dentifrices with high concentrations of fluoride appear to be the most rational approach to prevent and treat root caries. To the chemical effect of fluoride, toothbrushing adds mechanical removal of the dental biofilm. High concentration fluoride varnishes have also been proposed as effective in treating carious lesions. Whether dentifrices, varnishes or the combined use of varnish and fluoridated toothpaste result more effective is a matter of controversy and it needs to be elucidated. Non-invasive treatment avoids the complications inherent to treating frail people in a dental setting, decrease costs and importantly, allows increased coverage, as these therapies may be delivered by non-dentist personnel. Although the appealing idea of non-invasive treatment of root caries in older adults, evidence is still limited and more research appears necessary to both, confirm clinical success and elucidate the mechanisms involved in lesion arrestment.
Aim. To determine the effectiveness of non-invasive therapies for root caries and their impact in the quality of life of older adults.
Methodology. A double blind randomized controlled trial (RCT) on independently-living older adults aged sixty or more years is proposed. Subjects will undergo clinical and microbiological examination when recruited (baseline) with a six-month follow-up regime until completion of two years. To participate, subjects will have to have at least five teeth with exposed root surfaces and one carious lesion. Sample size was calculated and a sample of two-hundred and eighty-eight older adults is necessary, randomized into two study arms;
Group 1: toothpaste 1.450 ppm F-
Group 2: toothpaste 5.000 ppm F-
Dependent variables. Root caries incidence and activity, cariogenic bacteria and oral health-related quality of life will be assessed upon completion of the study and compared with baseline scores.
Expected results. Based on some previous data available, it is expected that a non-invasive therapy for root caries based on low-fluoride concentration will be less effective than high fluoride therapies in inactivating root caries lesions. These results may be used in novel therapeutic programs at the community level, as well as in private practice. Furthermore, these studies will shed light on potential mechanisms associated with non-invasive treatment of root caries, from a microbiology stand point. Since a non-invasive approach decreases costs and increases coverage of dental care for older adults, these results may contribute to increase access to care for the usually vulnerable population of older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fluoride Toothpaste | Experimental | Drug: Self-administered fluoridated dentifrices5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo) |
| Standard Fluoride Toothpaste | Active comparator | Drug: Self-administered fluoridated dentifrices1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 + years old
- community-dwelling
- living in a community with fluoridated water
- had five or more of their own teeth
- with ≥ 1 root caries lesion
Key exclusion criteria (2 listed)
- cognitive impairment
- alcoholism
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 |
|---|---|---|
| Self-administered fluoridated dentifricesAlso: Toothbrushing with high and standard fluoride dentifricesElderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided. | Drug | High Fluoride Toothpaste, Standard Fluoride Toothpaste |
Primary outcome
Root Caries Activity
Time frame: After 2 years of follow up
Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.
2 secondary outcomes
Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)
Time frame: Data registered at 2 years of follow-up
Salivary Flow
Time frame: Baseline and 2-year follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18194330Ekstrand K, Martignon S, Holm-Pedersen P. Development and evaluation of two root caries controlling programmes for home-based frail people older than 75 years. Gerodontology. 2008 Jun;25(2):67-75. doi: 10.1111/j.1741-2358.2007.00200.x. Epub 2008 Jan 13.
- Background: PubMed 23594784Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. A randomized clinical trial of the anti-caries efficacy of 5,000 compared to 1,450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Caries Res. 2013;47(5):391-8. doi: 10.1159/000348581. Epub 2013 Apr 9.
- Background: PubMed 23600985Gluzman R, Katz RV, Frey BJ, McGowan R. Prevention of root caries: a literature review of primary and secondary preventive agents. Spec Care Dentist. 2013 May-Jun;33(3):133-40. doi: 10.1111/j.1754-4505.2012.00318.x. Epub 2012 Dec 10.
- Background: PubMed 15271973Griffin SO, Griffin PM, Swann JL, Zlobin N. Estimating rates of new root caries in older adults. J Dent Res. 2004 Aug;83(8):634-8. doi: 10.1177/154405910408300810.
- Background: PubMed 17452559Griffin SO, Regnier E, Griffin PM, Huntley V. Effectiveness of fluoride in preventing caries in adults. J Dent Res. 2007 May;86(5):410-5. doi: 10.1177/154405910708600504.
- Background: PubMed 24603245Holmgren C, Gaucher C, Decerle N, Domejean S. Minimal intervention dentistry II: part 3. Management of non-cavitated (initial) occlusal caries lesions--non-invasive approaches through remineralisation and therapeutic sealants. Br Dent J. 2014 Mar;216(5):237-43. doi: 10.1038/sj.bdj.2014.147.
- Background: PubMed 20545716Ritter AV, Shugars DA, Bader JD. Root caries risk indicators: a systematic review of risk models. Community Dent Oral Epidemiol. 2010 Oct;38(5):383-97. doi: 10.1111/j.1600-0528.2010.00551.x.
- Background: PubMed 22899677Walls AW, Meurman JH. Approaches to caries prevention and therapy in the elderly. Adv Dent Res. 2012 Sep;24(2):36-40. doi: 10.1177/0022034512453590.
- Results publication: PubMed 25091189Leon S, Bravo-Cavicchioli D, Correa-Beltran G, Giacaman RA. Validation of the Spanish version of the Oral Health Impact Profile (OHIP-14Sp) in elderly Chileans. BMC Oral Health. 2014 Aug 4;14:95. doi: 10.1186/1472-6831-14-95.
- Derived from this study: PubMed 31176788Leon S, Gonzalez K, Hugo FN, Gambetta-Tessini K, Giacaman RA. High fluoride dentifrice for preventing and arresting root caries in community-dwelling older adults: A randomized controlled clinical trial. J Dent. 2019 Jul;86:110-117. doi: 10.1016/j.jdent.2019.06.002. Epub 2019 Jun 6.
- CEPAL (2013). Observatorio demográfico 2012. Proyecciones de poblaciónLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Root Caries
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.
Rodrigo A Giacaman, DDS, PhD principal investigator
University of Talca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Self-administered fluoridated dentifrices in people with Root Caries, run by University of Talca at 1 site in Chile.
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 5 inclusion and 2 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 2 Jan 2024. 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 Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Root Caries Activity (time frame: After 2 years of follow up). 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 NCT02647203, which also lists 10 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 2 Jan 2024.