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Assessing Effects of a Denture Gel on Gum Abrasions

23 juin 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

38

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Indiana
      • Fort Wayne, Indiana, États-Unis, 46825
        • Salus Research

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur factice: Groupe de contrôle
Autre: Sham Control
Subjects will perform their regular denture cleaning routine.
Expérimental: Groupe d'essai
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Abrasion Assessment (Number)
Délai: Day 3
The total number of abrasions pre-food challenge
Day 3
Abrasion Assessment (Size)
Délai: Day 3
The average size/area (in mm) of the total number of abrasions pre-food challenge
Day 3
Abrasion Assessment (Number)
Délai: Day 6
The total number of abrasions pre-food challenge
Day 6
Abrasion Assessment (Number)
Délai: Week 2
The total number of abrasions pre-food challenge
Week 2
Abrasion Assessment (Number)
Délai: Week 4
The total number of abrasions pre-food challenge
Week 4
Abrasion Assessment (Size)
Délai: Day 6
The average size/area (in mm) of the total number of abrasions pre-food challenge
Day 6
Abrasion Assessment (Size)
Délai: Week 2
The average size/area (in mm) of the total number of abrasions pre-food challenge
Week 2
Abrasion Assessment (Size)
Délai: Week 4
The average size/area (in mm) of the total number of abrasions pre-food challenge
Week 4
Mucosal Assessment
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Procter and Gamble

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2021

Achèvement primaire (Réel)

29 juin 2021

Achèvement de l'étude (Réel)

29 juin 2021

Dates d'inscription aux études

Première soumission

28 mai 2021

Première soumission répondant aux critères de contrôle qualité

3 juin 2021

Première publication (Réel)

4 juin 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 juin 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 juin 2022

Dernière vérification

1 juin 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2020089

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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