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Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies (SENSBZ)

6 août 2026 mis à jour par: Colgate Palmolive

Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies on Instant and Short-term Relief of Dentin Hypersensitivity: a Randomized Clinical Trial

The purpose of this clinical study is to evaluate and compare how well three different types of toothpaste technologies work to relieve tooth sensitivity, also known as dentin hypersensitivity. The study asks the question: How effective are toothpastes containing 8% Arginine, 8% Arginine with Zinc Phosphate, or 5% Calcium Sodium Phosphosilicate (CSPS) at providing immediate and short-term relief for people suffering from sensitive teeth?

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Dentin hypersensitivity (DH) is a common condition characterized by short, sharp pain arising from exposed dentin in response to external stimuli. This study investigates the clinical efficacy of three distinct dentin-occluding toothpaste technologies (8% Arginine, 8% Arginine with Zinc Phosphate, and 5% Calcium Sodium Phosphosilicate) to determine their effectiveness in providing both immediate (in-office) and short-term (14-day) relief.

Study Procedures and Visit Flow: During the screening phase, a trained dental examiner will evaluate potential participants to ensure they have at least two qualifying hypersensitive teeth (located anterior to the molars). Sensitivity is confirmed using an evaporative air blast stimulus delivered from a standard dental syringe.

At the baseline visit, eligible participants will complete the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) to assess the impact of DH on their quality of life. Clinical sensitivity will then be assessed using both tactile stimuli (measured via a 100-mm Visual Analogue Scale) and evaporative air blast stimuli (measured via the Schiff Cold Sensitivity Scale).

Following baseline assessments, participants are randomly assigned to one of the three study groups using a computer-generated block randomization list. To maintain the double-blind design for the subjects, the examining dentist, and the clinical staff, all investigational toothpastes are dispensed in a separate room and covered with white over-wrapping to conceal the product's identity and account for any aesthetic differences

Intervention Application: A key procedural component of this protocol is the evaluation of immediate relief following the first use of the products. Immediately after this initial application, clinical sensitivity (tactile and air blast) is re-evaluated.

For the at-home phase, all participants will be provided with their assigned toothpaste and a commercially available adult soft-bristled toothbrush. They will be instructed to brush their entire mouth for two minutes, twice daily (morning and evening), for the remainder of the 14-day study.

Follow-Up Restrictions: Participants will return to the clinical site for follow-up evaluations after 1, 3, 7, and 14 days of at-home product use. To ensure accurate sensitivity readings, participants are required to strictly refrain from any oral hygiene procedures, chewing gum, eating, and drinking for four hours prior to each of these follow-up visits.

Statistical Analysis Plan: The study is designed to enroll 132 subjects, allowing for an approximate 20% attrition rate to ensure that around 106 participants complete the 14-day trial. The sample size provides 80% power to detect a minimal statistically significant difference of 20% between the treatment group means.

Efficacy will be determined using an Analysis of Covariance (ANCOVA). The analysis will use the change from baseline scores as a covariate, and will also include age and gender as covariates if significant differences are found at baseline. If the ANCOVA reveals a significant difference among the groups, a Tukey's multiple comparison test will be performed for post-hoc evaluation.

Type d'étude

Interventionnel

Inscription (Estimé)

132

Phase

  • Phase 3

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.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Brésil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brésil, 91530-001
        • Recrutement
        • IEAPOM
        • Contact:

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

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Sign an Informed Consent Form;
  2. Male or female 18 to 70 years of age, inclusive;
  3. Be in good general health as determined by the study investigators (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
  4. Willingness to provide information related to their medical history;
  5. Available for the two (2) weeks duration of the study;
  6. Minimum of 16 uncrowned permanent natural teeth (excluding third molars and crowns);

  7. Must present at least two (2) sensitive teeth which must meet ALL of the following criteria:

    1. Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession;
    2. Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.

Exclusion Criteria:

  1. Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
  2. Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past month prior to start of the study;
  3. Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months, dental cleaning it's permitted;
  4. Sensitive teeth with a mobility greater than one;
  5. Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
  6. Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, daily use of analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner; or other drugs that could affect pain sensation;
  7. Current smokers and subjects with a history of alcohol or drug abuse;
  8. Participation in any other oral clinical study for the duration of this study;
  9. Self-reported pregnancy and/or currently breastfeeding;
  10. Allergies to oral care products, personal care consumer products, and/or their ingredients;
  11. Medical condition which prohibits not eating/drinking for 4 hours.
  12. Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
  13. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
  14. Current use of orthodontic appliances (including fixed braces, clear aligners, or permanent retainers)

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: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental Group
A commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate, paired with a commercially available adult soft bristle toothbrush
Médicament: 8% arginine + Zinc toothpaste
A commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate
Comparateur actif: Active Comparator Group
A commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS), paired with a commercially available adult soft bristle toothbrush
Médicament: 5% Calcium Sodium Phosphosilicate toothpaste
A commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS)
Comparateur actif: Positive Control Group
A commercially available fluoride toothpaste containing 8% arginine, paired with a commercially available adult soft bristle toothbrush
Médicament: 8% arginine toothpaste
A commercially available fluoride toothpaste containing 8% arginine

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Dentin Hypersensitivity (1)
Délai: Baseline and Immediately post-treatment
Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.
Baseline and Immediately post-treatment
Title: Change from Baseline in Dentin Hypersensitivity (2)
Délai: Baseline and 1 Day
Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.
Baseline and 1 Day
Title: Change from Baseline in Dentin Hypersensitivity (3)
Délai: Baseline and 3 Days
Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.
Baseline and 3 Days
Title: Change from Baseline in Dentin Hypersensitivity (4)
Délai: Baseline and 7 Days
Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.
Baseline and 7 Days
Title: Change from Baseline in Dentin Hypersensitivity (5)
Délai: Baseline and 14 Days
Dentin hypersensitivity is assessed using an evaporative air blast stimulus applied for one second to the cervical surface of two qualifying sensitive teeth. Subject response is scored using the Schiff Cold Sensitivity Scale: 0 = Does not respond; 1 = Responds but does not request discontinuation; 2 = Responds and requests discontinuation or moves; 3 = Considers stimulus painful and requests discontinuation. The subject-wise score is calculated by averaging the values of the two evaluated teeth, with higher scores indicating worse sensitivity. This measure evaluates the change in score from baseline.
Baseline and 14 Days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Tactile Stimulus (1)
Délai: Baseline and Immediately post-treatment
Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.
Baseline and Immediately post-treatment
Change from Baseline in Tactile Stimulus (2)
Délai: Baseline and 1 Day
Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.
Baseline and 1 Day
Change from Baseline in Tactile Stimulus (3)
Délai: Baseline and 3 Days
Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.
Baseline and 3 Days
Change from Baseline in Tactile Stimulus (4)
Délai: Baseline and 7 Days
Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.
Baseline and 7 Days
Change from Baseline in Tactile Stimulus (5)
Délai: Baseline and 14 Days
Pain perception is evaluated using a tactile mechanical stimulus (a standard dental explorer applied with approximately 50g of force for 3 seconds over the hypersensitive area). Participants self-rate their resulting discomfort by placing a mark on a 100-mm Visual Analogue Scale (VAS). The scale ranges from 0 mm (representing 'no pain') to 100 mm (representing 'unbearable pain'). Higher scores indicate a greater perception of pain. This measure evaluates the change in VAS score from baseline.
Baseline and 14 Days
Change from Baseline in Quality of Life Impact (DHEQ-15)
Délai: Baseline and 14 Days
The impact of dentin hypersensitivity on participants' quality of life is assessed using the Brazilian version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15). This self-reported instrument consists of 15 items categorized into five domains: restrictions, adaptation, social impact, emotional impact, and identity. Each item is scored on a 7-point Likert scale, ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The total score ranges from 15 to 105, where higher scores reflect a greater negative impact on the individual's quality of life. This measure evaluates the change in total score from baseline.
Baseline and 14 Days

Collaborateurs et enquêteurs

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

Parrainer

Colgate Palmolive

Collaborateurs

Federal University of Rio Grande do Sul

Les enquêteurs

  • Chercheur principal: Cassiano K Rosing, PhD, Federal University of Rio Grande do Sul

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)

29 juin 2026

Achèvement primaire (Estimé)

1 septembre 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

18 juin 2026

Première soumission répondant aux critères de contrôle qualité

18 juin 2026

Première publication (Réel)

24 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CRO-2026-02-SEN-BZ-CB

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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

Non

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