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Assessing Effects of a Denture Gel on Gum Abrasions

23 juni 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

38

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Indiana
      • Fort Wayne, Indiana, Verenigde Staten, 46825
        • Salus Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Controlegroep
Ander: Sham Control
Subjects will perform their regular denture cleaning routine.
Experimenteel: Test groep
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Procter and Gamble

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2021

Primaire voltooiing (Werkelijk)

29 juni 2021

Studie voltooiing (Werkelijk)

29 juni 2021

Studieregistratiedata

Eerst ingediend

28 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2021

Eerst geplaatst (Werkelijk)

4 juni 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juni 2022

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2022

Laatst geverifieerd

1 juni 2022

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2020089

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Klinische onderzoeken op Treatment Gel

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