Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes

NCT06197555 | Completed

• 1 other identifier: 2022/138
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dentine Hypersensitivity

Keywords

Dentin Hypersensitivity; Toothpaste; Fluoride; Arginine; Nano-Hydroxyapatite

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Clinical Periodontal Measurements

  Baseline, 16th week

• Clinical Periodontal Measurements

  Baseline, 16th week

• Clinical Periodontal Measurements

  Baseline, 16th week

• Clinical Periodontal Measurements

  Baseline, 16th week

Study Arms (4)

Group A (Sodium Monofluorophosphate)

ACTIVE COMPARATOR

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

Other: Sodium Monofluorophosphate

Group B (Stannous Fluoride)

ACTIVE COMPARATOR

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

Other: Stannous Fluoride

Group C (Nano-Hydroxyapatite)

ACTIVE COMPARATOR

Dentifrice containing Nano-Hydroxyapatite, daily homecare usage ApaCare®

Other: Nano-Hydroxyapatite

Group D (8% Arginine & Calcium Carbonate)

ACTIVE COMPARATOR

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

Other: 8% Arginine & Calcium Carbonate

Interventions

Sodium Monofluorophosphate 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 A (Sodium Monofluorophosphate)

Stannous Fluoride 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)

Nano-Hydroxyapatite 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)

8% Arginine & Calcium Carbonate 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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Altinbas University: lead

Study Sites (1)

Altinbas University

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

fluorophosphate; Tin Fluorides; nano-hydroxyapatite-collagen; Arginine; Calcium Carbonate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Calcium Compounds; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• İlknur ÖZENCİ

  Altinbas University

  STUDY CHAIR

• Şebnem DİRİKAN İPÇİ

  Altinbas University

  STUDY DIRECTOR

• Gökser ÇAKAR

  Altinbas University

  STUDY DIRECTOR

• Sevdenur GÜNENÇ

  Altinbas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 9, 2024
• Study Start: May 1, 2022
• Primary Completion: December 24, 2022
• Study Completion: February 20, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-12

Locations

TU (1)