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Effect of Toothpaste on the Reduction of Plaque and Inflammation

5. februar 2016 opdateret af: Katrin Lorenz, Technische Universität Dresden

Clinical Evaluation of the Effect of an Experimental Toothpaste on the Reduction of Dental Plaque and Gingival Inflammation

The purpose of this double blind study is to prove whether a fluoride containing toothpaste is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Before study start, investigators and study nurses will be trained on how to apply SOPs, parameters, and adverse event management. On-site monitoring will be done by the sponsor after recruitment, after visit 2 and after the final visit.

All source data will be entered in paper CRFs. For the statistical analysis these data will be entered into the data bank via double data entry. Programmed range checks, validity checks, consistency checks, and manual/visual data checks for medicinal plausibility will be done before the blind data review meeting. During blind data review meeting minor protocol violations will be recorded and assessed. No imputation of missing data will be done for ITT or PP analyses.

The sample size estimation was carried out by means of one-sided unpaired t-test with a one-sided significance level of α=0.05. For testing superiority of the test product over negative control, the investigators test the hypothesis, H0: μTest product - μNegative control ≤ 0 H1: μTest product - μNegative control > 0 by using a one-sided t-test with α=0.05. A relevant difference of Δ=0.14 and a standard deviation of σ=0.4 was assumed based on previous studies. When estimating a drop-out rate of about 20 % a total of 120 = 102 + 18 subjects per group will be assigned at study start. Drop-outs will not be replaced during the study.

The primary parameter is the difference of plaque index between baseline (V1) value and the value after 12 weeks +/- 5 days (V3) of product use. For primary statistical analysis, a t-tests (unpaired situation) will be performed at a one-sided significance level of α=0.05. The primary efficacy analysis will be performed on the ITT-analysis set.

Secondary variables will be assessed with t-tests and confidence intervals to compare differences between V2, V3, and baseline for test product group and negative control group. Descriptive statistics will be performed for oral examinations for each group (counts and percentages of scores for nominal and ordinal scaled data, for at least ordinal scaled data minimum, maximum, median, mean value and standard deviation).

A two-sided significance level of α=0.05 is chosen for all secondary analyses, no adjustment for multiplicity will be done. Safety assessments will be based mainly on the frequency of adverse events.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

241

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyskland
      • Dresden, Tyskland, 01307
        • Technische Universität Dresden

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

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female adults (aged 18 to 65 years),
  • Individuals with gingival inflammation, mean full-mouth GI ≥ 1.2 at inclusion,
  • Individuals with plaque, mean full-mouth PI ≥ 1.2 at inclusion,
  • Non-smokers or former smokers for at least 1 year or occasional smokers with a maximum of 5 cigarettes per week,
  • Individuals who have at least 20 own teeth excluding the wisdom teeth,
  • Subjects must have read, understood and signed the informed consent form
  • Willingness to abstain from use of interdental brushing devices that contain antibacterial agents, like amine fluoride, chlorhexidine, silver ions etc. during the full course of the study

Exclusion Criteria:

  • Individuals who have severe systemic diseases (tumors, infectious diseases) and diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics)
  • Individuals who have moderate and severe chronic or aggressive periodontitis (PSI > 2 in more than 2 sextants or PSI > 3),
  • Individuals who require antibiotic treatments for dental appointments (endocarditis prophylaxis), Individuals treated with antibiotics less than 8 weeks prior to the baseline examination and/or during the duration of the trial,
  • Individuals who have participated in another clinical study less than 4 weeks prior to the baseline examination,
  • Individuals who have mucosal diseases,
  • Individuals who have severe oro-pharyngeal infections,
  • Individuals who have significant dental disorders (e.g.: caries, suspected pulp pathology, abscess, pulpitis),
  • History of gingival surgery in the previous three month,
  • Ongoing dental treatment or any other medical treatment of the oral cavity,
  • Individuals who are pregnant or breast feeding,
  • Individuals with a history of chronic drug abuse or another illness which does not allow the person to assess the nature and/or possible consequences of the study,
  • Smokers with more than 5 cigarettes per week,
  • Individuals with known hypersensitivity or allergy to the test products and its ingredients,
  • Individuals who were treated with antibacterial mouthrinses (e. g. chlorhexidine) 4 weeks or less before recruitment,
  • Individuals unwilling to abstain from additional oral hygiene measures during the treatment phase with exception of their habitual mechanical cleaning procedures,
  • Non-Caucasians,
  • Subjects can be excluded at the principal investigators discretion.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Test group
Amine fluoride toothpaste
Andet: Amine fluoride
toothpaste
Placebo komparator: Control group
Placebo Sodium monofluorophosphate toothpaste
Andet: Placebo
toothpaste
Andre navne:
  • Sodium monofluorophosphate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plaque index (Silness and Loe 1964)
Tidsramme: Change in plaque index from baseline at 12 weeks
Difference of plaque index, compared between test group and control group.
Change in plaque index from baseline at 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plaque index (Silness and Loe 1964)
Tidsramme: Change in plaque index from baseline at 3 weeks
Difference of plaque index, compared between test group and control group.
Change in plaque index from baseline at 3 weeks
Plaque index (Silness and Loe 1964)
Tidsramme: Change in plaque index from week 3 at 12 weeks
Difference of plaque index, compared between test group and control group.
Change in plaque index from week 3 at 12 weeks
Gingival Index (Loe 1967)
Tidsramme: Change in gingival index from baseline at 3 weeks
Difference of gingival index, compared between test group and control group.
Change in gingival index from baseline at 3 weeks
Gingival Index (Loe 1967)
Tidsramme: Change in gingival index from baseline at 12 weeks
Difference of gingival index, compared between test group and control group.
Change in gingival index from baseline at 12 weeks
Gingival Index (Loe 1967)
Tidsramme: Change in gingival index from 3 weeks at week 12
Difference of gingival index, compared between test group and control group.
Change in gingival index from 3 weeks at week 12
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Tidsramme: Change in bleeding index from baseline at 12 weeks
Difference of bleeding index, compared between test group and control group.
Change in bleeding index from baseline at 12 weeks
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Tidsramme: Change in bleeding index from baseline at week 3
Difference of bleeding index, compared between test group and control group.
Change in bleeding index from baseline at week 3
Modified Sulcus Bleeding Index (Muhlemann and Son 1971):
Tidsramme: Change in bleeding index from week 3 at week 12
Difference of bleeding index, compared between test group and control group.
Change in bleeding index from week 3 at week 12
Adverse events
Tidsramme: up to 12 weeks from baseline
List all
up to 12 weeks from baseline

Samarbejdspartnere og efterforskere

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

Sponsor

Technische Universität Dresden

Samarbejdspartnere

Colgate Palmolive

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

1. september 2015

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

3. september 2015

Først indsendt, der opfyldte QC-kriterier

16. september 2015

Først opslået (Skøn)

17. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PAR012015

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 .

Kliniske forsøg med Gingivitis

Kliniske forsøg med Amine fluoride

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Iran

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner