Evaluation of Tooth Sensitivity and Whitening Effects of Different Content Teeth Whitening Agents

March 1, 2025 updated by: Betül Tokat

Evaluation of the Tooth Sensitivity and Whitening Effects of Calcium, Hydroxyapatite and Fluoride Containing Tooth Whitening Agents

The goal of this clinical study is to evaluate the success of different whitening agents in whitening teeth in healthy volunteers aged 18-50. Also, patients' tooth sensitivity will be assessed after application. The main questions it aims to answer are:

Is the teeth whitening success of different whitening agents similar? Did participants develop tooth sensitivity to whitening agents? The researchers will compare the whitening success of 3 different whitening agents and changes in tooth sensitivity within 1 year after application.

Participants:

Whitening agent will be applied in the clinic Visit our clinic for checkups and records after 1 week, 2 weeks, 1 month, 2 months, 4 months , 6 months and 1 year after application

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The participants in the study were healthy volunteers between the ages of 18-50. The number of volunteers was determined by using other studies similar to this study. There are 60 volunteers in three groups, 20 volunteers in each group. A different whitening agent is applied to each group by the researcher.

The researcher did not include volunteers with poor oral hygiene, smoking, tooth sensitivity, caries, or medication use in the study.

The researcher began the study by performing color measurement and sensitivity assessment before the procedure. Then he applied the whitening agent. The volunteers who underwent the whitening procedure will be evaluated in terms of both color measurements and sensitivity changes at the end of the treatment, 1st week, 2nd week, 1st month, 2nd month, 4th month, 6th month, and 1st year control sessions.

Each patient has their own evaluation form. There are different fields for both color and sensitivity in the form according to the control dates. All numerical data are recorded in their own fields.

Study Type

Interventional

Enrollment (Actual)

60

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
    • Melikgazi
      • Kayseri, Melikgazi, Turkey, 38000
        • Erciyes University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Vital teeth
  • Healthy gums
  • No tooth sensitivity
  • External discoloration ( tea,coffee..)
  • Good oral hygiene
  • No allergy to the material to be used

Exclusion Criteria:

  • Decayed and devital teeth
  • Presence of gingival bleeding
  • History of trauma
  • Presence of fractures, cracks and aesthetic restoration
  • Smoking

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
20 random patients( Whitening agent containing fluoride and 40% active ingredients)
Other: Bleaching Agents
whitening agent containing fluoride and 40% hydrogen peroxide
Other: Bleaching Agents
whitening agent containing calcium and 35% hydrogen peroxide
Other: Bleaching Agents
whitening agent containing hydroxyapatite and 18% hydrogen peroxide
Active Comparator: Group B
20 random patients(Whitening agent containing calcium and 35% active ingredients)
Other: Bleaching Agents
whitening agent containing fluoride and 40% hydrogen peroxide
Other: Bleaching Agents
whitening agent containing calcium and 35% hydrogen peroxide
Other: Bleaching Agents
whitening agent containing hydroxyapatite and 18% hydrogen peroxide
Active Comparator: Group C
20 random patients(Whitening agent containing hydroxyapatite and 18% active ingredients)
Other: Bleaching Agents
whitening agent containing fluoride and 40% hydrogen peroxide
Other: Bleaching Agents
whitening agent containing calcium and 35% hydrogen peroxide
Other: Bleaching Agents
whitening agent containing hydroxyapatite and 18% hydrogen peroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tooth color within 1 year after whitening
Time Frame: through study completion, an average of 1 year
Measurement and recording of numerical values of tooth color with vita easyshade device
through study completion, an average of 1 year
Change in tooth sensitivity after whitening within 1 year
Time Frame: through study completion, an average of 1 year
Numerical measurement of sensitivity after bleaching with VAS (visual analog scale)
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Betül Tokat

Collaborators

TC Erciyes University
Scientific Research Projects

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)

February 2, 2024

Primary Completion (Actual)

September 13, 2024

Study Completion (Estimated)

October 13, 2025

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 1, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU-DHF-BT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The work is not yet complete

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

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