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

NCT06216262 | Completed

• 1 other identifier: TSA-2023-4535
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dentin Sensitivity

Keywords

Arginine; Novamin; Propolis

Outcome Measures

Primary Outcomes (3)

• Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15)

  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'.

  for 8 weeks (initially, 4 weeks and 8 weeks)

• Visual Analogue Scale (VAS)

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

  for 8 weeks (initially, 4 weeks and 8 weeks)

• Schiff Sensitivity Scale

  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 1. subject responds to air stimulus but does not request discontinuaiton of stimulus 2. subject responds to air stimulus and requests discontinuaiton or moves from stimulus 3. subject responds to the air stimulus, considers stimulus to be painful and requests discontinuaiton of the stimulus

  for 8 weeks (initially, 4 weeks and 8 weeks)

Study Arms (6)

Control group

ACTIVE COMPARATOR

1450 ppm fluoride toothpaste

Other: Control group

Arginine

ACTIVE COMPARATOR

toothpaste containing arginine

Other: Arginine

Novamin

ACTIVE COMPARATOR

toothpaste containing novamin

Other: Novamin

Propolis

ACTIVE COMPARATOR

toothpaste containing propolis

Other: Propolis

Casein Phosphopeptide Amorphous Calcium Phosphate

ACTIVE COMPARATOR

Dental cream containing casein phosphopeptide amorphous calcium phosphate

Other: Control group; Other: Casein Phosphopeptide Amorphous Calcium Phosphate

Potassium Nitrate

ACTIVE COMPARATOR

mouthwash containing potassium nitrate

Other: Control group; Other: Potassium Nitrate

Interventions

Control group OTHER

Brushing teeth twice a day for 8 weeks

Casein Phosphopeptide Amorphous Calcium Phosphate; Control group; Potassium Nitrate

Arginine OTHER

Brushing teeth twice a day for 8 weeks

Arginine

Novamin OTHER

Brushing teeth twice a day for 8 weeks

Novamin

Propolis OTHER

Brushing teeth twice a day for 8 weeks

Propolis

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

Casein Phosphopeptide Amorphous Calcium Phosphate

Potassium Nitrate OTHER

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

Potassium Nitrate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University Faculty of Dentistry

Çanakkale, Turkey (Türkiye)

Location

Related Publications (4)

• Mason S, Burnett GR, Patel N, Patil A, Maclure R. Impact of toothpaste on oral health-related quality of life in people with dentine hypersensitivity. BMC Oral Health. 2019 Oct 22;19(1):226. doi: 10.1186/s12903-019-0919-x.

  PMID: 31640741 BACKGROUND

• Baker SR, Gibson BJ, Sufi F, Barlow A, Robinson PG. The Dentine Hypersensitivity Experience Questionnaire: a longitudinal validation study. J Clin Periodontol. 2014 Jan;41(1):52-9. doi: 10.1111/jcpe.12181. Epub 2013 Nov 6.

  PMID: 24117696 BACKGROUND

• Basaran S, Celik C. Turkish Adaptation of Dentine Hypersensitivity Experience Questionnaire (DHEQ). Community Dent Health. 2018 Mar 1;35(1):47-51. doi: 10.1922/CDH_4151Basaran05.

  PMID: 29369544 BACKGROUND

• Ayan G, Msmall i, Ukrainianssmall i, Ukrainianllsmall i, Ukrainian T, Buldur M. Home-use agents in the treatment of dentin hypersensitivity: clinical effectiveness evaluation with different measurement methods. Clin Oral Investig. 2025 Jan 15;29(1):63. doi: 10.1007/s00784-025-06155-1.

  PMID: 39810073 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Control Groups; Arginine; NovaMin; Propolis; casein phosphopeptide-amorphous calcium phosphate nanocomplex; potassium nitrate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 22, 2024
• Study Start: March 1, 2024
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)