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Clinical Study to Evaluate Remineralization Using an in Situ Model. (REMINSITU)

2 juni 2026 uppdaterad av: Colgate Palmolive

Clinical Study to Evaluate Enamel Remineralization Using Three Dentifrices in an in Situ Model.

This is a phase III clinical trial that aims to evaluate the enamel remineralization efficacy of three dentifrices on artificial caries lesions using an in situ model. The study involves 30 healthy volunteers, aged 18 to 70, who will participate in a randomized, triple-blind, three-period crossover design. Researchers will compare a 750 ppm MFP dentifrice against a 1450 ppm MFP positive control and a fluoride-free negative control to measure variations in mineral gain. Participants will wear a removable intraoral appliance containing human enamel blocks for three 14-day experimental phases. A 7-day washout period using will be implemented before and between each treatment phase.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This Phase III, randomized, single-center, triple-blind, crossover clinical study will evaluate the remineralization efficacy of three dentifrices on artificially induced initial enamel caries lesions. The research will involve 30 healthy participants aged 18 to 70 years who meet strict inclusion criteria. The experimental design will utilize an in situ model where participants will wear custom-made removable mandibular intraoral appliances containing four human enamel blocks with pre-formed artificial caries lesions. These lesions will be created laboratory-side using an acidified gel demineralization system before the blocks are mounted into the appliances.

The study will follow a nine-week timeline, divided into three 14-day experimental phases separated by 7-day washout periods to eliminate carryover effects, totaling 8 visits. During the treatment phases, subjects will be randomly assigned to a sequence of three test products: a test dentifrice with 750 ppm MFP, a positive control with 1450 ppm MFP, and a fluoride-free negative control. Each participant will receive a soft-bristle toothbrush and the assigned toothpastes.

The primary outcome will be the change in integrated mineral loss measured by transverse microradiography (TMR). Baseline mineral loss will be established from a slice of each block before intraoral exposure and compared to post-treatment analysis of the adjacent tissue. Secondary outcomes will include changes in lesion depth and fluorescence loss parameters assessed via Quantitative Light-induced Fluorescence (QLF).

Statistical analysis will be performed using a linear mixed-effects ANCOVA model to confirm the hypothesis that the 750 ppm MFP dentifrice promotes significantly greater remineralization than the negative control, with effects lower than or comparable to the high-fluoride positive control.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  • Males and females, between 18-70 years of age (inclusive);
  • Informed Consent Form signed and availability for the duration of the study;
  • Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
  • Willingness to provide information related to their medical history;
  • Minimum of 20 uncrowned permanent natural teeth (excluding third molars);
  • Normal salivary flow;
  • Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking.

Exclusion Criteria:

  • Oral pathology, chronic disease, or a history of allergy to testing products;
  • Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
  • Subject participating in any other clinical study;
  • Subject pregnant or breastfeeding;
  • Subject allergic to oral care products, personal care consumer products, or their ingredients;
  • Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
  • A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.;
  • Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
  • Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm;
  • Five or more decayed, untreated dental sites (cavities);
  • Current smokers and subjects with a history of alcohol or drug abuse;
  • Dental work prevents wearing of the appliance or a reported need to wear a night guard.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Test Group
Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush
Enhet: Tandborste
En kommersiellt tillgänglig tandborste med mjuk borst för vuxna
Läkemedel: Fluoride toothpaste containing 750 ppm MFP in a Dical base
Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days
Aktiv komparator: Positive Control Group
Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush
Enhet: Tandborste
En kommersiellt tillgänglig tandborste med mjuk borst för vuxna
Läkemedel: Fluoride toothpaste containing 1450 ppm MFP in a Dical base
Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days
Sham Comparator: Negative Control Group
Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush
Enhet: Tandborste
En kommersiellt tillgänglig tandborste med mjuk borst för vuxna
Läkemedel: Fluoride-free toothpaste in a Dical base
Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush for 14 days

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in integrated mineral loss (Δz)
Tidsram: 9 weeks
Integrated mineral loss (Δz) will be assessed by transverse microradiography (TMR). This outcome will evaluate the change from the baseline demineralized state (Δz0) to the post-treatment state (Δz1) to quantify the net mineral gain or loss.
9 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in lesion depth
Tidsram: 9 weeks
Post-treatments lesion depth (LD) will be assessed by TMR. For each experimental phase, post-treatment values will be compared with corresponding baseline measurements to determine the extent of remineralization.
9 weeks
Change from Baseline in Fluorescence Loss
Tidsram: 9 weeks
Fluorescence loss ΔF, will be assessed by quantitative light-induced fluorescence (QLF) to measure the percentage loss of fluorescence intensity. The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
9 weeks
Change from Baseline in Maximum Fluorescence Loss ΔFmax at 9 Weeks
Tidsram: 9 weeks
Maximum fluorescence loss ΔFmax at the deepest point of the lesion will be assessed by quantitative light-induced fluorescence (QLF). The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
9 weeks
Change from Baseline in Fluorescence Loss Volume (ΔQ) at 9 Weeks
Tidsram: 9 weeks
Fluorescence loss volume (ΔQ) will be assessed by quantitative light-induced fluorescence (QLF). The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
9 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Colgate Palmolive

Samarbetspartners

Federal University of Paraíba

Utredare

  • Huvudutredare: Fábio Correia Sampaio, PhD, Federal University of Paraíba

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 oktober 2026

Avslutad studie (Beräknad)

1 oktober 2026

Studieregistreringsdatum

Först inskickad

14 maj 2026

Först inskickad som uppfyllde QC-kriterierna

2 juni 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • CRO-2026-02-REMIN-BZ-CB

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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