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Assessing Effects of a Denture Gel on Gum Abrasions

23. juni 2022 oppdatert av: Procter and Gamble

A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions

This is a parallel design study. Up to 40 subjects with a full mandibular and full maxillary dentures will be enrolled into the study. Subjects will use their current denture care +/- a treatment gel for 4 weeks. Subjects will have an Oral Soft Tissue exam, a Mucosa Condition Assessment, and a Pre-Gum Abrasion Evaluation followed by a peanut challenge and then have a Post-Gum Abrasion Evaluation at designated timepoints.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a single center, two-treatment, parallel design study. Up to 40 subjects will be enrolled with a full mandibular and full maxillary denture with a history of food related abrasions.

At each visit, an Oral Soft Tissue exam, a Mucosa Condition Assessment and a Gum Abrasion Evaluation will be performed. At Baseline, the subjects will be randomized to a treatment group. At Baseline, Week 2, and Week 4 subjects will be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of peanuts (subjects will be permitted to take breaks if needed and drink small sips of water). Following the peanut challenge, a licensed dental professional will re-evaluate the number and size of abrasions. Subjects will receive a consumer questionnaire to complete as well prior to the Baseline, Week 2, and Week 4 assessments.

Studietype

Intervensjonell

Registrering (Faktiske)

38

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
    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46825
        • Salus Research

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

In order to be included in the study, each subject must:

  • Be 18 years of age;
  • Read, sign, and receive a copy of the Informed Consent prior to initiation of study procedures;
  • Have a full maxillary and mandibular denture and wear on a daily basis;
  • Have a history of food particles getting under their full denture and causing gum irritation;
  • Are willing to abstain from eating at least four hours prior to the visits;
  • Are willing to eat 4 X 20 grams of peanuts three times (Baseline, Week 2 and Week 4) without denture adhesive;
  • Clean their dentures on a daily basis;
  • Agree not to change their regular denture cleaning routine;
  • Agree to abstain from using denture adhesive during the study;
  • Agree to not participate in any other oral/dental product studies during the study.

Exclusion Criteria:

  • Exhibit evidence of obvious oral pathology, as determined by the Study Dentist, as a result of a mandatory OST examination on the first day of the study;
  • Are allergic to any of the ingredients contained in the study product gel;
  • Are allergic to peanuts;
  • Wear dentures overnight;
  • Are insulin-dependent and/or have any health condition(s) which would prevent compliance with study procedures;
  • Are routinely using denture adhesive;
  • Present with any disease or conditions that could be expected to increase their susceptibility to gum abrasion (like diabetes or xerostomia); or
  • Present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: Kontrollgruppe
Annen: Sham Control
Subjects will perform their regular denture cleaning routine.
Eksperimentell: Testgruppe
Enhet: Treatment Gel
In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Abrasion Assessment (Number)
Tidsramme: Day 3
The total number of abrasions pre-food challenge
Day 3
Abrasion Assessment (Size)
Tidsramme: Day 3
The average size/area (in mm) of the total number of abrasions pre-food challenge
Day 3
Abrasion Assessment (Number)
Tidsramme: Day 6
The total number of abrasions pre-food challenge
Day 6
Abrasion Assessment (Number)
Tidsramme: Week 2
The total number of abrasions pre-food challenge
Week 2
Abrasion Assessment (Number)
Tidsramme: Week 4
The total number of abrasions pre-food challenge
Week 4
Abrasion Assessment (Size)
Tidsramme: Day 6
The average size/area (in mm) of the total number of abrasions pre-food challenge
Day 6
Abrasion Assessment (Size)
Tidsramme: Week 2
The average size/area (in mm) of the total number of abrasions pre-food challenge
Week 2
Abrasion Assessment (Size)
Tidsramme: Week 4
The average size/area (in mm) of the total number of abrasions pre-food challenge
Week 4
Mucosal Assessment
Tidsramme: Day 3

The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score.

The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Day 3
Mucosal Assessment
Tidsramme: Day 6

The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score.

The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Day 6
Mucosal Assessment
Tidsramme: Week 2

The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score.

The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Week 2
Mucosal Assessment
Tidsramme: Week 4

The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score.

The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy.
Week 4

Samarbeidspartnere og etterforskere

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

Sponsor

Procter and Gamble

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 (Faktiske)

1. juni 2021

Primær fullføring (Faktiske)

29. juni 2021

Studiet fullført (Faktiske)

29. juni 2021

Datoer for studieregistrering

Først innsendt

28. mai 2021

Først innsendt som oppfylte QC-kriteriene

3. juni 2021

Først lagt ut (Faktiske)

4. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2020089

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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