Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes

Dentine Hypersensitivity Clinical Trial

Official title:

Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06197555
• Other study ID #: 2022/138
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: December 2023
• Source: Altinbas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 20, 2023
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Altinbas University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Altinbas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Clinical Periodontal Measurements	Probing depths (mm)	Baseline, 16th week
Secondary	Clinical Periodontal Measurements	Clinical attachment levels (mm)	Baseline, 16th week
Secondary	Clinical Periodontal Measurements	Plaque score (%),	Baseline, 16th week
Secondary	Clinical Periodontal Measurements	Bleeding score (%)	Baseline, 16th week