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

NCT06723054 | Active Not Recruiting

• 1 other identifier: UZH_ABS_2021_9
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Root Caries

Keywords

Elders; Root caries lesions; Prevention; Mouthwash

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of arrested root surface caries (RCarrested) on the exposed sound root surfaces

  180 days

Other Outcomes (1)

• 1. Incidence of new active coronal caries (DCnew) and 2. Number of arrested coronal caries (DCarrested)

  180 days

Study Arms (3)

Control group (CG)

PLACEBO COMPARATOR

Regular fluoride 220 ppm F mouthwash without erythritol

Other: regular fluoride 220 ppm F mouthwash without erythritol

Intervention group #1 (IG1)

ACTIVE COMPARATOR

220 ppm F mouthwash with erythritol

Other: regular fluoride 220 ppm F mouthwash with erythritol

Intervention group #2 (IG2)

ACTIVE COMPARATOR

500 ppm F mouthwash with erythritol

Other: high fluoride 500 ppm F mouthwash with erythritol

Interventions

regular fluoride 220 ppm F mouthwash without erythritol OTHER

The participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash without erythritol.

Control group (CG)

regular fluoride 220 ppm F mouthwash with erythritol OTHER

The participants will be asked to rinse once daily with a regular fluoride 220 ppm F mouthwash with erythritol.

Intervention group #1 (IG1)

high fluoride 500 ppm F mouthwash with erythritol OTHER

The participants will be asked to rinse once daily with a high fluoride 500 ppm F mouthwash with erythritol.

Intervention group #2 (IG2)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Root Caries

Interventions

Erythritol

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants and the investigators will be blinded to the randomization sequence as well as the prevention group. They will both not be aware of which mouthwash was used by the participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. dent.

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-10

Locations

CH (1)