An interventional study of regular fluoride 220 ppm F mouthwash without erythritol and regular fluoride 220 ppm F mouthwash with erythritol in Root Caries, sponsored by Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS. Active, not recruiting at 1 site in Switzerland. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS · Not applicable, Interventional, and Prevention
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.
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's enrollment of 69 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Regular fluoride 220 ppm F mouthwash without erythritol
Other: regular fluoride 220 ppm F mouthwash without erythritol
220 ppm F mouthwash with erythritol
Other: regular fluoride 220 ppm F mouthwash with erythritol
500 ppm F mouthwash with erythritol
Other: high fluoride 500 ppm F mouthwash with erythritol
The participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash without erythritol.
The participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash with erythritol.
The participants will be asked to rinse once daily with a high fluoride 500 ppm F mouthwash with erythritol.
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.
Time frame: 180 days
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).
Time frame: 180 days
1. Incidence of new active coronal caries (DCnew) and 2. Number of arrested coronal caries (DCarrested)
For the other Outcome 1. each of the five tooth surfaces (i.e. distal, mesial, buccal, oral, and occlusal) will be assessed. The tooth surfaces will be assessed at timepoints T0, T1 and T2 and will be compared to the tooth status at the previous visit. A new coronal caries (DCnew) is defined if a sound tooth surface, ICDAS 0, becomes a ICDAS 1, 2, 3, 4, 5 or 6. For the other Outcome 2. each of the five tooth surfaces (i.e. distal, mesial, buccal, oral, and occlusal) will be assessed. All the active coronal caries which became an arrested coronal 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.
Time frame: 180 days
Plan to share: Undecided
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This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS