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The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population

7. september 2026 opdateret af: HALEON

A 12-Week, Randomized, Controlled, Examiner-blind, Clinical Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population

The aim of this study is to evaluate the efficacy of the test toothpaste compared to a regular fluoride toothpaste in the reducing gingivitis and plaque accumulation in Chinese participants with plaque-induced gingivitis.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This will be a single-center, 12-week, randomized, controlled, examiner-blind, two-group, stratified, parallel group design clinical study in participants with localized plaque-induced gingivitis. The study will investigate the ability of the test toothpaste to improve gingival health and plaque accumulation in participants with plaque induced gingivitis only. Sufficient participants will be screened to randomize approximately 120 participants to ensure approximately 108 participants (approximately 54 per group) complete the study.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
120

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200011
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong Universi-ty School of Medicine
        • Kontakt:
          • Xi Chen

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • A participant who is willing and able to comply with scheduled visits, treatment plan, study restrictions, lifestyle considerations and other study procedures.
  • A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
  • A participant with localized plaque-induced gingivitis, in the opinion of the clinical examiner or medically qualified designee, as confirmed by visual examination.

Exclusion Criteria:

  • A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
  • A participant who has participated in other studies (including non-medicinal studies) involving study product(s) within 30 days prior to study entry and/or during study participation.
  • A participant with, in the opinion of the investigator (or medically qualified designee), an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
  • A participant who is breastfeeding.
  • A participant with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
  • A participant unwilling or unable to comply with lifestyle considerations described in this protocol.
  • Participants with, in the opinion of the investigator or medically qualified designee, any clinically significant/relevant abnormalities in medical history or oral examination, or any other condition, that would affect the individual's ability to understand and follow study procedures and requirements.
  • A participant with any medical condition which, in the opinion of the investigator or medically qualified designee, are causing xerostomia.
  • Participants with any medical condition which, in the opinion of the investigator or medically qualified designee, could directly influence gingival bleeding.
  • A participant who habitually rinses with water during toothbrushing (self-reported at Screening (Visit 1)).
  • Participants with recent history (within the last year) of alcohol or other substance abuse.
  • A participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening (self-reported at Screening (Visit 1)).
  • A participant who currently uses smokeless forms of tobacco (example [e.g.], chewing tobacco, nicotine-based e-cigarettes).
  • A participant with oral mucosa disease (e.g., oral lichen planus, oral leukoplakia etc.) or a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that, in the opinion of the investigator or dentally qualified designee, would compromise study outcomes or the oral health of the Participant /clinical examiner if they were to participate in the study.
  • A participant with a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator or dentally qualified designee, could interfere with toothbrush usage or act as a plaque retentive factor.
  • A Participant who has previously been enrolled in this study.
  • A Participant who has used an anti-bacterial mouthwash (e.g., chlorhexidine) or use of any oral care product within 14 days of Baseline (Visit 2) that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health.

  • Periodontal Exclusions:

    1. A participant with severe periodontitis or signs of active periodontitis who, in the opinion of the investigator or dentally qualified designee, should not participate in the study.
    2. A participant with gingivitis which, in the opinion of the investigator or dentally qualified designee, would not be expected to respond to treatment with an anti-Gingivitis toothpaste.
    3. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.

  • Dental Exclusions:

    1. A participant with active caries that, in the opinion of the investigator or dentally qualified designee, could compromise study outcomes or the oral health of the participant if they were to participate in the study.
    2. A participant with a partial or full denture and with an orthodontic appliance (bands, appliances or fixed/ removable retainers).
    3. A Participant who has received orthodontic therapy within 12 months of Screening.
    4. A participant with numerous restorations in a poor state of repair.
    5. A participant with any dental condition (e.g., overcrowding) that, in the opinion of the investigator or dentally qualified designee, could compromise study outcomes or the oral health of the participant if they were to participate in the study.
    6. A participant who has had dental prophylaxis or teeth bleaching within 12 weeks of Screening.
    7. A participant with high levels of extrinsic stain or calculus deposits that, in the opinion of the investigator or dentally qualified designee, could interfere with Baseline (preprophylaxis) plaque assessments.
  • A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition
  • A participant who is not eligible for dental prophylaxis based on investigator or medically qualified designee review of their laboratory (blood) test results which includes blood platelet; white blood cell out of normal range; Prothrombin Time (PT) exceeds 15 seconds; Activated Partial Thromboplastin Time (APTT) exceeds 35 seconds; positive HIV test; positive HBV test, Hepatitis B Surface Antigen (HbsAg) and positive syphilis test.
  • A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Test Toothpaste
Participants will brush their teeth with a ribbon of Test Toothpaste across the full brush head for at least one timed minute twice a day (morning and evening) for 12 Weeks.
Andet: Test Toothpaste
A toothpaste containing Isopropyl Methyl Phenol (IPMP).
Andet: Control Toothpaste (Regular Fluoride Toothpaste)
Participants will brush their teeth with a ribbon of Control Toothpaste across the full brush head for at least one timed minute twice a day (morning and evening) for 12 Weeks.
Andet: Regular Fluoride Toothpaste
A regular sodium fluoride toothpaste containing 1450 parts per million (ppm).

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Bleeding Index (Bl) at Week 12
Tidsramme: At Week 12
Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 millimeter (mm) into the gingival sulcus at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. Presence/ absence of gingival bleeding will be assessed for 30 seconds after probing and will be scored on a 3-points scale ranging from 0 to 2, where 0 equal to (=) no bleeding after 30 seconds; 1= bleeding observed within 30 seconds of probing; 2= bleeding observed immediately on probing. Lower score will indicate an improvement in the symptoms.
At Week 12

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean BI At Week 2 and 6
Tidsramme: At Week 2 and 6
Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 mm into the gingival sulcus epithelium at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. Presence/ absence of gingival bleeding will be assessed for 30 seconds after probing and will be scored on a 3-points scale ranging from 0 to 2, where 0= no bleeding after 30 seconds; 1= bleeding observed within 30 seconds of probing; 2= bleeding observed an immediately on probing. Lower score will indicate an improvement in the symptoms.
At Week 2 and 6
Mean Number of Bleeding Site (NBS) At Week 2, 6 and 12
Tidsramme: At Week 2, 6 and 12
Gingival bleeding will be assessed as an invasive assessment of BI. It will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva with six sites per tooth. To perform the bleeding assessment, a round-ended probe will be inserted approximately 1 mm into the gingival sulcus epithelium at approximately 60 degrees and will be moved from the distal interproximal area to the mesial interproximal area. The presence/ absence of gingival bleeding will be assessed for 30 seconds after probing. The NBS for each participant will be calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.
At Week 2, 6 and 12
Mean Overall Turesky Modification of the Quigley Hein Index (TPI) At Week 2, 6 and 12
Tidsramme: At Week 2, 6 and 12
TPI will be a non-invasive assessment of supra-gingival plaque accumulation. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed for all evaluable surfaces of the facial and lingual surfaces of each scoreable tooth. Three scores will be recorded facially and three lingually, generating six scores per tooth. The disclosed plaques will then be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= Thin, continuous band of plaque 1 mm or smaller at the cervical margin of the tooth; 3= Band of plaque wider than 1 mm but covering less than 1/3 of the area; 4= Plaque covering at least 1/3 but less than 2/3 of the area; 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score will indicate an improvement in the symptoms.
At Week 2, 6 and 12
Mean Interproximal TPI At Week 2, 6 and 12
Tidsramme: At Week 2, 6 and 12
TPI will be a non-invasive assessment of supra-gingival plaque accumulation. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed for all evaluable surfaces of the facial and lingual surfaces of each scoreable tooth. Three scores will be recorded facially and three lingually, generating six scores per tooth. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= Thin, continuous band of plaque 1 mm or smaller at the cervical margin of the tooth; 3= Band of plaque wider than 1mm but covering less than 1/3 of the area; 4= Plaque covering at least 1/3 but less than 2/3 of the area; 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score will indicate an improvement in the symptoms.
At Week 2, 6 and 12
Mean Modified Gingival Index (MGI) At Week 2, 6 and 12
Tidsramme: At Week 2, 6 and 12
The MGI is a non-invasive visual assessment of gingival health. It will be assessed for all evaluable teeth. For each tooth, scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score will indicate an improvement in the symptoms.
At Week 2, 6 and 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
HALEON

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. september 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. januar 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. januar 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
7. september 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
7. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
11. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
11. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
7. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 400317

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

IPD-delingstidsramme

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD-delingsadgangskriterier

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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