Terminé

A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

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Ce qui est testé

Stannous Fluoride dentifice

+ Sodium Monofluorophosphate dentifrice

Dispositif médicalAutre
Qui peut participer

Sensibilité Dentinaire

+ Maladies stomatognathiques

+ Maladies des dents

De 18 à 65 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : février 2016
Voir le détail du protocole

Résumé

Sponsor principalGlaxoSmithKline
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 février 2016

Date à laquelle le premier participant a commencé l'étude.

This single centre, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice.

Titre officielA Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Sponsor principalGlaxoSmithKline
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

263 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 65 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Sensibilité DentinaireMaladies stomatognathiquesMaladies des dents

Critères

Inclusion Criteria: * Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form * Good general and mental health with, in the opinion of the investigator or medically qualified designee: A. No clinically significant and relevant abnormalities in medical history or upon oral examination. B. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. \- Dental health At Screening: A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years. B. Good general oral health, with a minimum of 20 natural teeth. C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: * Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR). * Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1. * Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response). At Baseline: D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria: \- Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2) Exclusion Criteria: * Pregnant or breast feeding women * Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. * Currently taking antibiotics or has taken antibiotics within two weeks of Baseline. * Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. - Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes. * Any condition which, in the opinion of the investigator, causes xerostomia. * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients * Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit. * Recent history (within the last year) of alcohol or other substance abuse * Dental prophylaxis within four weeks of Screening. * Tongue or lip piercing or presence of dental implants. * Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments). * Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening. * Teeth bleaching within eight weeks of Screening * Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening. * Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine. * Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the investigator. * Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening * Individuals who require antibiotic prophylaxis for dental procedures

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Participants will apply (under supervision) a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing will be permitted

Groupe II

Participants will apply (under supervision) a pea-sized dose of dentifrice containing Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing will be permitted.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

GSK Investigational Site

Bristol, United KingdomOuvrir GSK Investigational Site dans Google Maps
Terminé1 Centres d'Étude