Clinical trial

Root Caries Prevention Using Fluoride Varnish Fortified With Strontium-doped Bioactive Glass Ceramic: a Randomized Double-blind Controlled Clinical Trial

NCT06131957

Name

UW23-451

Description

The goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.

Trial arms

Trial start

2024-01-15

Estimated PCD

2027-01-01

Trial end

2027-12-01

Status

Recruiting

Treatment

Fluoride varnish with SBGC

The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) mixed with 7.5% SBGC (Dencare (Chongqing) Oral Care Co., Ltd).

Arms:

Fluoride varnish with SBGC

Fluoride varnish

The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)

Arms:

Fluoride varnish without SBGC

Other names:

Duraphat

Size

540

Primary endpoint

New root caries lesions and restorations

Baseline, 12, 24, 36 months

Eligibility criteria

Inclusion Criteria: * Adult \> 60 years old * good collaborative relationships Exclusion Criteria: * less than 8 natural teeth * have severe medical conditions * are in use of high fluoride toothpaste

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized assigned to either experimental group or controlled group.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "The subjects and the clinical team including the dentist and the dental surgery assistant will all be blinded to the subjects' assignment of the intervention.", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 540, 'type': 'ESTIMATED'}}

Updated at

2024-02-21

1 organization

1 product

2 indications

Organization

The University of Hong Kong

Product

Fluoride varnish

Indication

Dental Caries

Indication

Root Caries