Root CariesNCT06723054
Prevention and Arrest of Root Caries Lesions with High Fluoride Concentration Mouthwash Versus Normal Fluoride Concentration Mouthwash in Elderly Patients
A study testing regular fluoride 220 ppm F mouthwash without erythritol, regular fluoride 220 ppm F mouthwash with erythritol and high fluoride 500 ppm F mouthwash with erythritol in people with Root Caries, run by Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS at 1 site in Switzerland.
Trial summary
The study evaluats the effectiveness of regular fluoride 220 ppm F with erythritol and high fluoride 500 ppm F with erythritol mouthwashes against a placebo (regular fluoride 220 ppm F mouthwash) in the prevention of new root caries lesions. 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?
- regular fluoride 220 ppm F mouthwash without erythritol, regular fluoride 220 ppm F mouthwash with erythritol and high fluoride 500 ppm F mouthwash with erythritol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2023to Mar 2025
- 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
- Dentinal root caries lesions with no painful symptomology
- Minimum of 3 teeth present in the mouth
- Can follow instructions for oral hygiene
Who cannot join
- Symptomatic carious teeth
- Root surface active lesion which is easily penetrated by sharp probe with light force (ICDAS Grade 3 and soft needs to be filled)
- Non-carious attrition, erosion or abrasion cavities
- Periodontally compromised teeth with Grade 3 mobility, and active signs of infections.
- Not willing or able to sign informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Center for Dental Medicine, Clinic of General, Special care, and Geriatric Dentistry
Zurich, 8032
About this study
Official title: Prevention and Arrest of Root Caries Lesions with High Fluoride Concentration Mouthwash Versus Normal Fluoride Concentration Mouthwash in Elderly Patients: a Randomized, Double-blind Controlled Trial.
The study evaluats the effectiveness of regular fluoride 220 ppm F with erythritol and high fluoride 500 ppm F with erythritol mouthwashes against a placebo (regular fluoride 220 ppm F mouthwash) in the prevention of new root caries lesions.
Read the detailed description
Preserving natural teeth becomes essential to avoid complex restorative procedures in old age. For this the concepts of preventive treatment constitute an important point. The method of topical application via fluorides is a widely used and well-known technique for prevention of caries. Numerous studies have demonstrated the preventive effect of fluorides on caries. The prevention of root caries and the effectiveness of fluorides will depend mainly on two factors used: first is the fluoride agent, and the second is fluoride content. There is abundant evidence with regard to the preventive effect of high fluoride applications on the root caries. Furthermore, it has also been recommended on the regular use of high fluoride 5000 ppm F toothpaste twice daily in the prevention and inactivating the root caries in adults. However, high fluoride toothpastes are fairly expensive and not available as over-the-counter (OTC) products and require a prescription. This may be an aspect when the elders have limited access. A more economical solution and one which can be easily procured is deemed necessary.
Mouth rinses are considered as cosmetic products and are available as OTC products and do not require prescriptions. They are also relatively less expensive in comparison to the high fluoride toothpastes. Fluoridated mouthwashes are generally recommended in moderate-high caries risk population or individual. The normal fluoride range in a mouth wash is normally between 100 ppm to 500 ppm F. This may not be sufficient to bring a preventive effect in high risk individuals. It has been demonstrated that a small positive trend for sodium fluoride (NaF) mouth rinses against placebo in reducing the initiation of coronal and root caries.
Erythritol is a natural sugar substitute and is frequently used as a sweetener. It is easily excreted by the kidneys and does not increase the blood sugar. It is often an additive in mouthwashes as a sweetening agent. It is known to have anti-plaque aggregating and bacteriostatic effect.
Perhaps, the use of erythritol in regular fluoride mouthwash (220 ppm F) in combination with high F mouthwash (500 ppm F) might be beneficial and augment the preventive effect of fluoride in mouth rinses. This may be a viable alternative to expensive and prescription options.
Therefore, the primary objective of this study is to evaluate the effectiveness of regular fluoride 220 ppm F with erythritol and high fluoride 500 ppm F with erythritol mouthwashes against a placebo (regular fluoride 220 ppm F mouthwash) in the prevention of new root caries lesions.
The secondary endpoints/outcome set for this study is the number of arrested root surface caries after intervention with the test products (i.e., a change of root surface caries from ICDAS classification 1 to 2 and 3 to 4, respectively will be considered as arresting).
The tertiary endpoint/outcome set for this study are as follows: 1. Incidence of new coronal caries after the intervention with the test products and 2. the number of arrested coronal caries after the intervention with the test products.
- Conditions
- Root Caries
- Being tested
- regular fluoride 220 ppm F mouthwash without erythritol, regular fluoride 220 ppm F mouthwash with erythritol, high fluoride 500 ppm F mouthwash with erythritol
- Keywords
- Elders, Root caries lesions, Prevention, Mouthwash
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular fluoride 220 ppm F mouthwash without erythritolOther
The participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash without erythritol.
regular fluoride 220 ppm F mouthwash with erythritolOther
The participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash with erythritol.
high fluoride 500 ppm F mouthwash with erythritolOther
The participants will be asked to rinse once daily with a high fluoride 500 ppm F mouthwash with erythritol.
| Study group | Role | What they receive |
|---|---|---|
| Control group (CG) | Placebo comparator | Regular fluoride 220 ppm F mouthwash without erythritol Receives: Other: regular fluoride 220 ppm F mouthwash without erythritol |
| Intervention group #1 (IG1) | Active comparator | 220 ppm F mouthwash with erythritol Receives: Other: regular fluoride 220 ppm F mouthwash with erythritol |
| Intervention group #2 (IG2) | Active comparator | 500 ppm F mouthwash with erythritol Receives: Other: high fluoride 500 ppm F mouthwash with erythritol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new root surface caries (RCnew) on the exposed sound root surfaces
For this purpose of the trial each of the four tooth surfaces (i.e. distal, mesial, buccal, oral) will be assessed. All the exposed sound root surfaces will be taken into account and assessed at timepoints T0, T1 and T2 and will be compared to the tooth status at the previous visit. A new root surface caries is defined if a sound root surface, ICDAS 0, becomes a ICDAS 1, 2, 3, 4 or 6.
Measured: 180 days
Secondary outcomes (1)
Number of arrested root surface caries (RCarrested) on the exposed sound root surfaces
For this purpose of the trial each of the four tooth surfaces (i.e. distal, mesial, buccal, oral) will be assessed. All the active root surfaces caries which became a arrested root surfaces caries will be taken into account. The assessment will take place at timepoints T0, T1 and T2. The tooth status will each time be compared to the tooth status at the previous visit. A arrested root surface caries is defined if a active root surface caries lesion (ICDAS: 1 or 3) that becomes inactive root surface caries lesion (ICDAS: 2 or 4).
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Feb 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- This study is designed to be a double-blind, randomized, controlled, parallel, single-center, intention-to treat (ITT), trial with an allocation ratio of 1: 1: 1 and of a non-inferiority framework. The participants will be randomly allotted to one of the three study groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723054
- Sponsor's protocol ID
- UZH_ABS_2021_9
- Other IDs
- UZH_ABS_2021_9
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Arrest of Root Caries Lesions with High Fluoride Concentration Mouthwash Versus Normal Fluoride Concentration Mouthwash in Elderly Patients: a Randomized, Double-blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT06723054
- Acronym / sponsor ID
- UZH_ABS_2021_9
- Conditions
- Root Caries
- Keywords
- Elders, Root caries lesions, Prevention, Mouthwash
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MASUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 9 Dec 2024 (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 study evaluats the effectiveness of regular fluoride 220 ppm F with erythritol and high fluoride 500 ppm F with erythritol mouthwashes against a placebo (regular fluoride 220 ppm F mouthwash) in the prevention of new root caries lesions.
Detailed description
Preserving natural teeth becomes essential to avoid complex restorative procedures in old age. For this the concepts of preventive treatment constitute an important point. The method of topical application via fluorides is a widely used and well-known technique for prevention of caries. Numerous studies have demonstrated the preventive effect of fluorides on caries. The prevention of root caries and the effectiveness of fluorides will depend mainly on two factors used: first is the fluoride agent, and the second is fluoride content. There is abundant evidence with regard to the preventive effect of high fluoride applications on the root caries. Furthermore, it has also been recommended on the regular use of high fluoride 5000 ppm F toothpaste twice daily in the prevention and inactivating the root caries in adults. However, high fluoride toothpastes are fairly expensive and not available as over-the-counter (OTC) products and require a prescription. This may be an aspect when the elders have limited access. A more economical solution and one which can be easily procured is deemed necessary.
Mouth rinses are considered as cosmetic products and are available as OTC products and do not require prescriptions. They are also relatively less expensive in comparison to the high fluoride toothpastes. Fluoridated mouthwashes are generally recommended in moderate-high caries risk population or individual. The normal fluoride range in a mouth wash is normally between 100 ppm to 500 ppm F. This may not be sufficient to bring a preventive effect in high risk individuals. It has been demonstrated that a small positive trend for sodium fluoride (NaF) mouth rinses against placebo in reducing the initiation of coronal and root caries.
Erythritol is a natural sugar substitute and is frequently used as a sweetener. It is easily excreted by the kidneys and does not increase the blood sugar. It is often an additive in mouthwashes as a sweetening agent. It is known to have anti-plaque aggregating and bacteriostatic effect.
Perhaps, the use of erythritol in regular fluoride mouthwash (220 ppm F) in combination with high F mouthwash (500 ppm F) might be beneficial and augment the preventive effect of fluoride in mouth rinses. This may be a viable alternative to expensive and prescription options.
Therefore, the primary objective of this study is to evaluate the effectiveness of regular fluoride 220 ppm F with erythritol and high fluoride 500 ppm F with erythritol mouthwashes against a placebo (regular fluoride 220 ppm F mouthwash) in the prevention of new root caries lesions.
The secondary endpoints/outcome set for this study is the number of arrested root surface caries after intervention with the test products (i.e., a change of root surface caries from ICDAS classification 1 to 2 and 3 to 4, respectively will be considered as arresting).
The tertiary endpoint/outcome set for this study are as follows: 1. Incidence of new coronal caries after the intervention with the test products and 2. the number of arrested coronal caries after the intervention with the test products.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study is designed to be a double-blind, randomized, controlled, parallel, single-center, intention-to treat (ITT), trial with an allocation ratio of 1: 1: 1 and of a non-inferiority framework. The participants will be randomly allotted to one of the three study groups.
| Arm | Type | Receives |
|---|---|---|
| Control group (CG) | Placebo comparator | Other: regular fluoride 220 ppm F mouthwash without erythritolRegular fluoride 220 ppm F mouthwash without erythritol |
| Intervention group #1 (IG1) | Active comparator | Other: regular fluoride 220 ppm F mouthwash with erythritol220 ppm F mouthwash with erythritol |
| Intervention group #2 (IG2) | Active comparator | Other: high fluoride 500 ppm F mouthwash with erythritol500 ppm F mouthwash with erythritol |
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
- Dentinal root caries lesions with no painful symptomology
- Minimum of 3 teeth present in the mouth
- Can follow instructions for oral hygiene
Key exclusion criteria (5 listed)
- Symptomatic carious teeth
- Root surface active lesion which is easily penetrated by sharp probe with light force (ICDAS Grade 3 and soft needs to be filled)
- Non-carious attrition, erosion or abrasion cavities
- Periodontally compromised teeth with Grade 3 mobility, and active signs of infections.
- Not willing or able to sign informed consent
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 |
|---|---|---|
| regular fluoride 220 ppm F mouthwash without erythritolThe participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash without erythritol. | Other | Control group (CG) |
| regular fluoride 220 ppm F mouthwash with erythritolThe participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash with erythritol. | Other | Intervention group #1 (IG1) |
| high fluoride 500 ppm F mouthwash with erythritolThe participants will be asked to rinse once daily with a high fluoride 500 ppm F mouthwash with erythritol. | Other | Intervention group #2 (IG2) |
Primary outcome
Incidence of new root surface caries (RCnew) on the exposed sound root surfaces
Time frame: 180 days
For this purpose of the trial each of the four tooth surfaces (i.e. distal, mesial, buccal, oral) will be assessed. All the exposed sound root surfaces will be taken into account and assessed at timepoints T0, T1 and T2 and will be compared to the tooth status at the previous visit. A new root surface caries is defined if a sound root surface, ICDAS 0, becomes a ICDAS 1, 2, 3, 4 or 6.
1 secondary outcome
Number of arrested root surface caries (RCarrested) on the exposed sound root surfaces
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regular fluoride 220 ppm F mouthwash without erythritol, regular fluoride 220 ppm F mouthwash with erythritol and high fluoride 500 ppm F mouthwash with erythritol in people with Root Caries, run by Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS at 1 site in Switzerland.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Dec 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 Switzerland. 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 new root surface caries (RCnew) on the exposed sound root surfaces (time frame: 180 days). 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 9 Dec 2024.