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

August 23, 2024 updated by: Gizem AYAN, Çanakkale Onsekiz Mart University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Canakkale, Turkey
        • Canakkale Onsekiz Mart University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
1450 ppm fluoride toothpaste
Other: Control group
Brushing teeth twice a day for 8 weeks
Active Comparator: Arginine
toothpaste containing arginine
Other: Arginine
Brushing teeth twice a day for 8 weeks
Active Comparator: Novamin
toothpaste containing novamin
Other: Novamin
Brushing teeth twice a day for 8 weeks
Active Comparator: Propolis
toothpaste containing propolis
Other: Propolis
Brushing teeth twice a day for 8 weeks
Active Comparator: Casein Phosphopeptide Amorphous Calcium Phosphate
Dental cream containing casein phosphopeptide amorphous calcium phosphate
Other: Control group
Brushing teeth twice a day for 8 weeks
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
Active Comparator: Potassium Nitrate
mouthwash containing potassium nitrate
Other: Control group
Brushing teeth twice a day for 8 weeks
Other: Potassium Nitrate
Following the procedure in the control group, mouthwash twice a day in the morning and evening for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
for 8 weeks (initially, 4 weeks and 8 weeks)
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).
for 8 weeks (initially, 4 weeks and 8 weeks)
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

  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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Çanakkale Onsekiz Mart University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

August 23, 2024

Study Completion (Actual)

August 23, 2024

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSA-2023-4535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dentin Sensitivity

Clinical Trials on Control group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe