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Completed

NCT Number: NCT06197555

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.

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Key information

Conditions

Dentine Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Altinbas University

Istanbul, 34147, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Hypersensitivity Reduction

    Time frame: Baseline, 2nd week, 4th week, 16th week

    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').

  2. Hypersensitivity Reduction

    Time frame: Baseline, 2nd week, 4th week, 16th week

    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.

Secondary outcomes

  1. Clinical Periodontal Measurements

    Time frame: Baseline, 16th week

    Probing depths (mm)

  2. Clinical Periodontal Measurements

    Time frame: Baseline, 16th week

    Clinical attachment levels (mm)

  3. Clinical Periodontal Measurements

    Time frame: Baseline, 16th week

    Plaque score (%),

  4. Clinical Periodontal Measurements

    Time frame: Baseline, 16th week

    Bleeding score (%)

Sponsors and collaborators

Lead sponsor

Altinbas University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 9, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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