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A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis

3. november 2017 oppdatert av: Sunstar Americas
The purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. The primary purpose of this study is to support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

62

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Massachusetts
      • Cambridge, Massachusetts, Forente stater, 02142
        • The Forsyth Institute

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

16 år til 63 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Willing and able to read, understand and sign an Informed Consent form.
  • Good general health as evidenced by the medical history.
  • Between 18 and 65 years of age.
  • Male or female.
  • Minimum of 20 teeth, excluding crowns and third molar teeth.
  • Mean whole mouth Modified Gingival Index of greater-than or equal to 2.0 at baseline.
  • Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits.
  • Willing to abstain from eating and drinking in the morning of visits, only drinking water is allowed.
  • Willing to abstain from interdental cleaning, chewing gums, oral whitening, mouth rinse and tobacco products for the study duration.
  • Able to understand and follow study directions.
  • No known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria

  • Presence of orthodontic appliances.
  • Intra-oral soft tissue lesions due to pathology or trauma
  • Patients with aggressive periodontitis, acute necrotizing ulcerative gingivitis, or gross decay at discretion of PI.
  • More than two sites with pocket depth >5mm and concomitant attachment loss of >2mm.
  • Pregnant or lactating females or females of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
  • Use of antibiotics within 3 months of enrollment
  • History of drug use that is associated with gum overgrowth (i.e., Dilantin, nifedipine, etc)
  • Chronic use of medication such as steroids, NSAIDs (more than 2-3 days/week), anti-coagulant medications, immunosuppressant medications or any other medications that in the opinion of the Investigator would interfere with the evaluation or confound interpretation of the study results. Use of low dose of acetylsalicylic acid (81 mg) is permitted.
  • Unwilling to sign a confidentiality statement and/or return the test products.
  • Medical condition which requires pre-medication prior to dental visits/procedures.
  • Immune compromised individuals (HIV, AIDS, immunosuppressive drug therapy).
  • Current use of probiotics or probiotic containing food (i.e., yogurt)

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: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Probiotics Lozenge (twice a day)
Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
Annen: Probiotics
Aktiv komparator: Probiotics Lozenge (once a day)
Subjects take their lozenge once a day, one lozenge at night after brushing.
Annen: Probiotics
Placebo komparator: Placebo Lozenge (once a day)
Subjects take their lozenge once a day, one lozenge at night after brushing.
Annen: Probiotics

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Modified Gingival Index (MGI)
Tidsramme: 4, 12 and 24 weeks

Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation)

  1. Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit
  2. Mild inflammation of the entire gingival unit
  3. Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or papillary gingival unit
  4. Severe inflammation (marked redness and edema/hyper-trophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.

Whole mouth MGI scores were calculated by summing all scores and dividing by the number of examined scorable sites.
4, 12 and 24 weeks
Change From Baseline in Bleeding on Probing (BOP)
Tidsramme: 4, 12 and 24 weeks
Bleeding on probing was assessed 30 seconds after probing. A dichotomous scoring system was used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively. BOP (%) is a percentage of sites BOP.
4, 12 and 24 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Plaque Index (PI)
Tidsramme: 4, 12 and 24 weeks

Plaque Index of Turesky Modification of Quigley-Hein (Turesky, Gilmore et al. 1970) (PI) was scored on all natural teeth (except third molars) after disclosing with erythrosine solution. Scores Criteria:

0 No plaque

  1. Separate flecks of plaque at the cervical margin of the tooth
  2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
  3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
  4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth
  5. Plaque covering two-thirds or more of the crown of the tooth
4, 12 and 24 weeks
Change From Baseline in Probing Depth (PD)
Tidsramme: 4, 12 and 24 weeks
Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm.
4, 12 and 24 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Inflammatory Markers in Gingival Crevicular
Tidsramme: 15 days, 4, 12 and 24 weeks
Gingival Crevicular Fluid (GCF) samples will be analyzed for inflammatory cytokines/chemokines and matrix metalloproteases using multiplexing ELISA.
15 days, 4, 12 and 24 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Sunstar Americas

Etterforskere

  • Hovedetterforsker: Hatice Hasturk, DDS, PhD, The Forsyth Institute

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

1. mars 2013

Primær fullføring (Faktiske)

1. januar 2015

Studiet fullført (Faktiske)

1. mars 2015

Datoer for studieregistrering

Først innsendt

11. mars 2013

Først innsendt som oppfylte QC-kriteriene

12. mars 2013

Først lagt ut (Anslag)

14. mars 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. desember 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2017

Sist bekreftet

1. november 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLP-2013-1-23

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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