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Completed

NCT Number: NCT06216262

Evaluation of the Effectiveness of Home-Use Desensitizing Agents on Dentin Hypersensitivity

Dentin sensitivity is one of the most common problems in society and affects the quality of life related to oral health. Agents such as toothpaste, mouthwash, and dental cream are home-type desensitizing agents used as the first step in the treatment of dentin hypersensitivity. A total of 180 individuals with dentin sensitivity will be included in the study and the individuals will be randomly divided into 6 groups. Individuals in the 1st Group will be given arginine-containing toothpaste, individuals in the 2nd Group will be given novamin-containing toothpaste, individuals in the 3rd Group will be given propolis-containing toothpaste, individuals in the 4th Group will be given casein phosphopeptide amorphous calcium phosphate-containing dental cream, and individuals in the 5th Group will be given mouthwash containing potassium nitrate. Classic toothpaste with 1450 ppm fluoride will be distributed to individuals in the control group, which is the 6th group. The Dentin Hypersensitivity Experience Questionnaire (DHEQ-15), consisting of 15 questions, will be used to evaluate dentin sensitivity. Visual Analogue Scale (VAS) will be used to determine the individual's pain score in dentin sensitivity, and the individual will be asked to score the intensity of pain experienced between 0-10 points. Finally, in the evaluation of dentin sensitivity, a single dentist will apply air to the cervix of the tooth from a distance of 1 cm for 1 second, and the Schiff Sensitivity Scale score will be determined through clinical examination. A score between 0 and 3 will be determined by the dentist according to the patient's response to the air stimulus. The effectiveness of the home-use desensitizing agents used in the treatment of dentin hypersensitivity was evaluated with DHEQ-15, VAS and Schiff Sensitivity Scale; Baseline, 4th and 8th week scores will be compared.

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Key information

Conditions

Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canakkale Onsekiz Mart University Faculty of Dentistry

Çanakkale, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 18-70 years old
  • General health condition is good
  • Individuals with sensitivity in 2 or more non-adjacent teeth

Exclusion criteria

  • Pregnant or breastfeeding women
  • Advanced periodontal diseases
  • Chronic diseases that may affect the study results
  • Major oral pathologies
  • Use of anticonvulsant, antihistamine, antidepressant, sedative, tranquilizer medication
  • Use of desensitizing paste in the last 3 months
  • Individuals who have been treated for periodontal disease in the last 12 months

Treatment and study plan

Control Group

Other

Brushing teeth twice a day for 8 weeks

Arginine

Other

Brushing teeth twice a day for 8 weeks

Novamin

Other

Brushing teeth twice a day for 8 weeks

Propolis

Other

Brushing teeth twice a day for 8 weeks

Casein Phosphopeptide Amorphous Calcium Phosphate

Other

Following the procedure in the control group, it is applied to the tooth surface once a day for 3 minutes before going to bed at night for 8 weeks

Potassium Nitrate

Other

Following the procedure in the control group, mouthwash twice a day in the morning and evening for 8 weeks

Primary outcomes

  1. Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15)

    Time frame: for 8 weeks (initially, 4 weeks and 8 weeks)

    Dentin Hypersensitivity Experience Questionnaire-15 (DHEQ-15) is a 7-point Likert scale form consisting of 15 questions used to evaluate dentin sensitivity, with answers ranging from 'strongly agree' to 'strongly disagree'.

  2. Visual Analogue Scale (VAS)

    Time frame: for 8 weeks (initially, 4 weeks and 8 weeks)

    VAS is a scale in which the individual evaluates the pain level between 0 (no hurt) and 10 (hurts worst).

  3. Schiff Sensitivity Scale

    Time frame: for 8 weeks (initially, 4 weeks and 8 weeks)

    In the evaluation of dentin hypersensitivity, a single dentist will apply air to the cervix of the tooth from a distance of 1 cm for 1 second during a clinical examination and the Schiff Sensitivity Scale score will be determined.

    0: subject does not respond to air stimulus

    • subject responds to air stimulus but does not request discontinuaiton of stimulus
    • subject responds to air stimulus and requests discontinuaiton or moves from stimulus
    • subject responds to the air stimulus, considers stimulus to be painful and requests discontinuaiton of the stimulus

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Aug 26, 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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