In-situ study on the remineralizing effect of a highly fluoridated toothpaste, a fluoride gel, and a fluoride varnish

Switzerland (ICTRP)

ICTRP Trial ID
DRKS00022321 (ICTRP)

Official title (approved by ethics committee)
In-situ-Studie zur remineralisierenden Wirkung einer hochfluoridierten Zahnpasta, eines Fluoridgels und eines Fluoridlackes (BASEC)

Academic title
Remineralizing effect of a highly fluoridated toothpaste, a fluoride gel and a fluoride varnish in situ (ICTRP)

Public title
Remineralizing effect of a highly fluoridated toothpaste, a fluoride gel and a fluoride varnish in situ (ICTRP)

Disease under investigation

K02Dental caries (ICTRP)

Intervention under investigation
Group 1: The study design is a double-blinded, randomized, cross-over in situ trial with four treatment legs. After screening for general eligibility dental impressions of the lower jaw will be taken and appliances with bilateral flanges will be prepared [Koulourides et al., 1974]. In each of both flanges two pre-demineralized bovine enamel and two pre-demineralized bovine dentine specimens will be inserted. Specimens will be inserted 1 mm below the acrylic under a plastic mesh (Perfect Splint-System Hager & Werken, Duisburg, Germany) mimicking plaque-retaining surfaces [Meyer-Lueckel et al., 2007 Meyer-Lueckel et al., 2015b Schirrmeister et al., 2007]. Each specimen included one sound enamel/dentin area and one demineralized lesion.
The factors under evaluation will be:
intervention at four levels: daily tooth brushing
(1. leg) with normally fluoridated toothpaste [1450ppm F],
(2. leg) with highly fluoridated toothpaste [5000 ppm F],
(3. leg) with normally fluoridated toothpaste [1450ppm F] and weekly application of a fluoride gel [12500 ppm F]
(4. leg) with normally fluoridated toothpaste [1450ppm F] and single application of a fluoride varnish [22500ppm F]
baseline substrate at two levels: enamel or dentin
baseline substrate condition at two levels: sound or pre-demineralized
The volunteers will wear intraoral mandibular appliances for four legs of four weeks each, with the in situ exposure only being interrupted during meals and for oral hygiene resulting in in a total wearing time of 22-23h per day. Each of the four treatment legs will be immediately preceded by a 1-week lead-in period. For each test cycle the participant will receive a new tooth brush (Oral-B Indicator Proctor & Gamble, Schwalbach am Taunus, Ger (ICTRP)

Type of trial
interventional (ICTRP)

Trial design
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: crossover; Study design purpose: prevention (ICTRP)

Inclusion/Exclusion criteria
Inclusion criteria: give written informed consent
be between the ages of 18 and 70
be in good general health
agree not to participate in any other clinical study for the duration of this study
agree to refrain from using any non-study oral hygiene products including: toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their usual toothbrush and toothpaste which will be used during the Acclimation period between each visit
have a minimum of 20 teeth (excluding third molars)
agree to return for the scheduled clinical visits and follow study procedures (ICTRP)

Exclusion criteria: active participation in another oral/dental products clinical study
current severe chronic illness or infectious disease
drug or alcohol abuse
eating disorders,
pregnancy or breast feeding
antibiotic use (2 months before and during study) or medication reducing salivary flow
intake of other medications that might have an impact on the outcome
bad oral cleanliness, no agreement to comply with study design
known allergic reactions to any of the test substances
other allergic reactions to dental materials or oral hygiene products

Primary and secondary end points
At the participant level, the primary endpoint is reached after 20 weeks (final examination and delivery of the fourth phase appliance, nutritional protocol, products and toothbrush).

At the specimen level, the primary endpoint is reached after the evaluation of the mineral content and the lesion depth of the specmines and after evaluation of the biofilm on the samples. (ICTRP)

not available

Registration date
08.07.2020 (ICTRP)

Incorporation of the first participant
01.02.2023 (ICTRP)

Secondary sponsors
not available

Additional contacts
Richard Wierichs, richard.wierichs@zmk.unibe.ch, +41 31 632 25 80, Universitt BernKlinik fr Zahnerhaltung, Prventiv- und Kinderzahnmedizin (ICTRP)

Secondary trial IDs
not available

Results-Individual Participant Data (IPD)
No (ICTRP)

Further information on the trial
http://drks.de/search/en/trial/DRKS00022321 (ICTRP)