Prevention and Arrest of Root Caries Lesions with High Fluoride Concentration Mouthwash Versus Normal Fluoride Concentration Mouthwash in Elderly Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Root Caries
• Intervention / Treatment: Other: regular fluoride 220 ppm F mouthwash without erythritol; Other: regular fluoride 220 ppm F mouthwash with erythritol; Other: high fluoride 500 ppm F mouthwash with erythritol

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • University of Zurich, Center for Dental Medicine, Clinic of General, Special care, and Geriatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group (CG); Regular fluoride 220 ppm F mouthwash without erythritol	Other: 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 without erythritol.
Active Comparator: Intervention group #1 (IG1); 220 ppm F mouthwash with erythritol	Other: regular fluoride 220 ppm F mouthwash with erythritol; The participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash with erythritol.
Active Comparator: Intervention group #2 (IG2); 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 high fluoride 500 ppm F mouthwash with erythritol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	180 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 days

Collaborators and Investigators

• Sponsor: Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Mouthwash; Elders; Root caries lesions
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Root Caries; Physiological Effects of Drugs; Protective Agents; Vasodilator Agents; Cariostatic Agents; Erythritol; Fluorides
• Other Study ID Numbers: UZH_ABS_2021_9 (Other Identifier: University Zurich, ZZM / ABS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No