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

NCT ID: NCT06216262

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-08-23

Brief Summary

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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.

Detailed Description

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Conditions

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Dentin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

1450 ppm fluoride toothpaste

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

Brushing teeth twice a day for 8 weeks

Arginine

toothpaste containing arginine

Group Type ACTIVE_COMPARATOR

Arginine

Intervention Type OTHER

Brushing teeth twice a day for 8 weeks

Novamin

toothpaste containing novamin

Group Type ACTIVE_COMPARATOR

Novamin

Intervention Type OTHER

Brushing teeth twice a day for 8 weeks

Propolis

toothpaste containing propolis

Group Type ACTIVE_COMPARATOR

Propolis

Intervention Type OTHER

Brushing teeth twice a day for 8 weeks

Casein Phosphopeptide Amorphous Calcium Phosphate

Dental cream containing casein phosphopeptide amorphous calcium phosphate

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

Brushing teeth twice a day for 8 weeks

Casein Phosphopeptide Amorphous Calcium Phosphate

Intervention Type 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

mouthwash containing potassium nitrate

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

Brushing teeth twice a day for 8 weeks

Potassium Nitrate

Intervention Type OTHER

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

Interventions

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Control group

Brushing teeth twice a day for 8 weeks

Intervention Type OTHER

Arginine

Brushing teeth twice a day for 8 weeks

Intervention Type OTHER

Novamin

Brushing teeth twice a day for 8 weeks

Intervention Type OTHER

Propolis

Brushing teeth twice a day for 8 weeks

Intervention Type OTHER

Casein Phosphopeptide Amorphous Calcium Phosphate

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

Intervention Type OTHER

Potassium Nitrate

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Çanakkale Onsekiz Mart University

OTHER

Sponsor Role lead

Responsible Party

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Gizem AYAN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Canakkale Onsekiz Mart University Faculty of Dentistry

Çanakkale, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31640741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24117696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29369544 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39810073 (View on PubMed)

Other Identifiers

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TSA-2023-4535

Identifier Type: -

Identifier Source: org_study_id

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