Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes

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.

Study Overview

• Status: Completed
• Conditions: Dentine Hypersensitivity
• Intervention / Treatment: Other: Sodium Monofluorophosphate; Other: Stannous Fluoride; Other: Nano-Hydroxyapatite; Other: 8% Arginine & Calcium Carbonate

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • Altinbas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Sodium Monofluorophosphate); Dentifrice containing Sodium Monofluorophosphate, daily homecare usage Colgate®, Cavity Protection	Other: 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.
Active Comparator: Group B (Stannous Fluoride); Dentifrice containing Stannous Fluoride, daily homecare usage Oral B®, Gum Calm & Sensitivity	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.
Active Comparator: Group C (Nano-Hydroxyapatite); Dentifrice containing Nano-Hydroxyapatite, daily homecare usage ApaCare®	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.
Active Comparator: Group D (8% Arginine & Calcium Carbonate); Dentifrice containing 8% Arginine & Calcium Carbonate, daily homecare usage Colgate®, Sensitive Pro-Relief	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypersensitivity Reduction	Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	Baseline, 2nd week, 4th week, 16th week
Hypersensitivity Reduction	The Schiff Scale examiner covers the adjacent teeth on either side of the patient's hypersensitive tooth with his/her fingers. Air from the tip of the dental unit's air-water sprayer is applied to the cervical region of the hypersensitive tooth at a distance of approximately 1 cm for 1 second. The degree of hypersensitivity is scored according to the Schiff cold air sensitivity scale. Scoring : Score 0: The individual does not respond to the stimulus. Score 1: The individual responds to the stimulus but does not request its termination. Score 2: The individual responds to the stimulus and requests its termination or moves to avoid the stimulus. Score 3: The individual responds to the stimulus, finds the stimulus painful and requests its termination. The pain persists for a few seconds after the stimulus is terminated.	Baseline, 2nd week, 4th week, 16th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Periodontal Measurements	Probing depths (mm)	Baseline, 16th week
Clinical Periodontal Measurements	Clinical attachment levels (mm)	Baseline, 16th week
Clinical Periodontal Measurements	Plaque score (%),	Baseline, 16th week
Clinical Periodontal Measurements	Bleeding score (%)	Baseline, 16th week

Collaborators and Investigators

• Sponsor: Altinbas University
• Investigators: Study Chair: İlknur ÖZENCİ, Altinbas University; Study Director: Şebnem DİRİKAN İPÇİ, Altinbas University; Study Director: Gökser ÇAKAR, Altinbas University; Principal Investigator: Sevdenur GÜNENÇ, Altinbas University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 24, 2022
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Fluoride; Toothpaste; Arginine; Dentin Hypersensitivity; Nano-Hydroxyapatite
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Protective Agents; Calcium-Regulating Hormones and Agents; Cariostatic Agents; Antacids; Calcium; Fluorides; Calcium Carbonate; Tin Fluorides; Fluorophosphate
• Other Study ID Numbers: 2022/138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No