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Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies (SENSBZ)

6 sierpnia 2026 zaktualizowane przez: 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?

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

132

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Brazylia
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazylia, 91530-001
        • Rekrutacyjny
        • IEAPOM
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Experimental Group
A commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate, paired with a commercially available adult soft bristle toothbrush
Lek: 8% arginine + Zinc toothpaste
A commercially available fluoride toothpaste containing 8% arginine + Zinc Phosphate
Aktywny komparator: Active Comparator Group
A commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS), paired with a commercially available adult soft bristle toothbrush
Lek: 5% Calcium Sodium Phosphosilicate toothpaste
A commercially available fluoride toothpaste containing 5% Calcium Sodium Phosphosilicate (CSPS)
Aktywny komparator: Positive Control Group
A commercially available fluoride toothpaste containing 8% arginine, paired with a commercially available adult soft bristle toothbrush
Lek: 8% arginine toothpaste
A commercially available fluoride toothpaste containing 8% arginine

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Dentin Hypersensitivity (1)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Tactile Stimulus (1)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Colgate Palmolive

Współpracownicy

Federal University of Rio Grande do Sul

Śledczy

  • Główny śledczy: Cassiano K Rosing, PhD, Federal University of Rio Grande do Sul

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 września 2026

Ukończenie studiów (Szacowany)

1 września 2026

Daty rejestracji na studia

Pierwszy przesłany

18 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

24 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 sierpnia 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CRO-2026-02-SEN-BZ-CB

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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