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

2. juni 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Test Group
Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush
Enhet: Tannbørste
En kommersielt tilgjengelig tannbørste med myk bust for voksne
Legemiddel: 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: Tannbørste
En kommersielt tilgjengelig tannbørste med myk bust for voksne
Legemiddel: 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-komparator: Negative Control Group
Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush
Enhet: Tannbørste
En kommersielt tilgjengelig tannbørste med myk bust for voksne
Legemiddel: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in integrated mineral loss (Δz)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in lesion depth
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Colgate Palmolive

Samarbeidspartnere

Federal University of Paraíba

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. oktober 2026

Datoer for studieregistrering

Først innsendt

14. mai 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CRO-2026-02-REMIN-BZ-CB

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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