Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes

NCT ID: NCT06197555

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-02-20

Brief Summary

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Dentin hypersensitivity is a common problem in society. Untreated hypersensitivity affects the patient's quality of life, complicates plaque control and increases the risk of caries and periodontal disease. This study aimed to evaluate the clinical efficacy of desensitizing toothpastes containing sodium fluoride, stannous fluoride, nano-hydroxyapatite, 8% arginine and calcium carbonate.

Fourty eight patients with at least two teeth with positive responses to air and mechanical stimulus were included in the study and were divided into four groups. Sodium fluoride (Colgate®, Cavity Protection) in group A, stannous fluoride (Oral B® Gum Calm \& Sensitivity) in group B, nano-hydroxyapatite (ApaCare®) in group C and 8% arginine and calcium carbonate combination in group D (Colgate® Sensitive Pro- ReliefTM) were used by the patients continuously for 16 weeks. Dentin hypersensitivity, by using VAS and Shiff scores and periodontal parameters were evaluated at baseline, 2nd week, 4th week and last 16th week.

Detailed Description

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Conditions

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Dentine Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A (Sodium Monofluorophosphate)

Dentifrice containing Sodium Monofluorophosphate, daily homecare usage Colgate®, Cavity Protection

Group Type ACTIVE_COMPARATOR

Sodium Monofluorophosphate

Intervention Type OTHER

Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.

Group B (Stannous Fluoride)

Dentifrice containing Stannous Fluoride, daily homecare usage Oral B®, Gum Calm \& Sensitivity

Group Type ACTIVE_COMPARATOR

Stannous Fluoride

Intervention Type OTHER

Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.

Group C (Nano-Hydroxyapatite)

Dentifrice containing Nano-Hydroxyapatite, daily homecare usage ApaCare®

Group Type ACTIVE_COMPARATOR

Nano-Hydroxyapatite

Intervention Type OTHER

Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.

Group D (8% Arginine & Calcium Carbonate)

Dentifrice containing 8% Arginine \& Calcium Carbonate, daily homecare usage Colgate®, Sensitive Pro-Relief

Group Type ACTIVE_COMPARATOR

8% Arginine & Calcium Carbonate

Intervention Type OTHER

Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.

Interventions

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Sodium Monofluorophosphate

Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.

Intervention Type OTHER

Stannous Fluoride

Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.

Intervention Type OTHER

Nano-Hydroxyapatite

Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.

Intervention Type OTHER

8% Arginine & Calcium Carbonate

Test toothpaste, participants will brush selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. The method of application of these agents will be the fingertip method. Patients continued to use the paste twice daily, morning and evening, for 16 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Dentin hypersensitivity complaints
* Systemically healthy
* Not during pregnancy \& lactation
* No sensitivity treatment in the last 6 months
* Forty-eight patients with positive response to VAS and Schiff tests were included.

Exclusion Criteria

People who have;

* Any systemic disease
* Take regular medication for any other reason
* Undergone periodontal surgery within the last 6 months,
* History of allergy to toothpaste materials,
* Active caries, restoration and/or bridge on the sensitive tooth,
* Orthodontic appliances,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Altinbas University

OTHER

Sponsor Role lead

Responsible Party

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Sevdenur GÜNENÇ

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İlknur ÖZENCİ

Role: STUDY_CHAIR

Altinbas University

Şebnem DİRİKAN İPÇİ

Role: STUDY_DIRECTOR

Altinbas University

Gökser ÇAKAR

Role: STUDY_DIRECTOR

Altinbas University

Sevdenur GÜNENÇ

Role: PRINCIPAL_INVESTIGATOR

Altinbas University

Locations

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Altinbas University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2022/138

Identifier Type: -

Identifier Source: org_study_id

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