Healthy VolunteersNCT06855940
Evaluation of Tooth Sensitivity and Whitening Effects of Different Content Teeth Whitening Agents
A study testing Bleaching Agents in people with Healthy Volunteers and Discoloration of Teeth, run by Betül Tokat at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Discoloration of Teeth, Bleaching Sensitivity
- What is being tested?
- Bleaching Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2024to 13 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Vital teeth
- Healthy gums
- No tooth sensitivity
- External discoloration ( tea,coffee..)
- Good oral hygiene
- No allergy to the material to be used
Who cannot join
- Decayed and devital teeth
- Presence of gingival bleeding
- History of trauma
- Presence of fractures, cracks and aesthetic restoration
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the 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.
- Being tested
- Bleaching Agents
- Keywords
- Bleaching Agents, Bleaching agent \( BOOST 40%\), Bleaching teeth, Discoloration of Teeth, Sensitivity, Tooth
- Medical subject headings
- Tooth Discoloration, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleaching AgentsOther
whitening agent containing fluoride and 40% hydrogen peroxide
Bleaching AgentsOther
whitening agent containing calcium and 35% hydrogen peroxide
Bleaching AgentsOther
whitening agent containing hydroxyapatite and 18% hydrogen peroxide
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 20 random patients( Whitening agent containing fluoride and 40% active ingredients) Receives: Other: Bleaching Agents |
| Group B | Active comparator | 20 random patients(Whitening agent containing calcium and 35% active ingredients) Receives: Other: Bleaching Agents |
| Group C | Active comparator | 20 random patients(Whitening agent containing hydroxyapatite and 18% active ingredients) Receives: Other: Bleaching Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tooth color within 1 year after whitening
Measurement and recording of numerical values of tooth color with vita easyshade device
Measured: through study completion, an average of 1 year
Change in tooth sensitivity after whitening within 1 year
Numerical measurement of sensitivity after bleaching with VAS (visual analog scale)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start2 Feb 2024
- Primary completion13 Sep 2024
- Study completion13 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: X bleaching agents Group B: Y bleaching agents Group C: Z bleaching agents
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betül Tokat
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University, Scientific Research Projects
- Responsible party
- Sponsor-investigator, Betül Tokat, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855940
- Sponsor's protocol ID
- EU-DHF-BT-01
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The work is not yet complete
Publications
Matis BA. Tray whitening: what the evidence shows. Compend Contin Educ Dent. 2003 Apr;24(4A):354-62.
PubMed 12793212Meireles SS, Heckmann SS, Santos IS, Della Bona A, Demarco FF. A double blind randomized clinical trial of at-home tooth bleaching using two carbamide peroxide concentrations: 6-month follow-up. J Dent. 2008 Nov;36(11):878-84. doi: 10.1016/j.jdent.2008.07.002. Epub 2008 Aug 22.
PubMed 18722039Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients' acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent. 2005 Mar-Apr;30(2):156-63.
PubMed 15853099Tokat B, Arslan S. Evaluation of tooth sensitivity and whitening effects of tooth whitening agents containing calcium, hydroxyapatite and fluoride. Odontology. 2026 Oct 4. doi: 10.1007/s10266-026-01565-3. Online ahead of print.
PubMed 42830343
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tooth Sensitivity and Whitening Effects of Calcium, Hydroxyapatite and Fluoride Containing Tooth Whitening Agents
- ClinicalTrials.gov ID
- NCT06855940
- Acronym / sponsor ID
- EU-DHF-BT-01
- Keywords
- Bleaching Agents, Bleaching agent \( BOOST 40%\), Bleaching teeth, Discoloration of Teeth, Sensitivity, Tooth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Betül TokatUniversity, hospital or other
- Collaborators
- TC Erciyes University, Scientific Research Projects
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Oct 2025 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Group A: X bleaching agents Group B: Y bleaching agents Group C: Z bleaching agents
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Bleaching Agents20 random patients( Whitening agent containing fluoride and 40% active ingredients) |
| Group B | Active comparator | Other: Bleaching Agents20 random patients(Whitening agent containing calcium and 35% active ingredients) |
| Group C | Active comparator | Other: Bleaching Agents20 random patients(Whitening agent containing hydroxyapatite and 18% active ingredients) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Vital teeth
- Healthy gums
- No tooth sensitivity
- External discoloration ( tea,coffee..)
- Good oral hygiene
Key exclusion criteria (5 listed)
- Decayed and devital teeth
- Presence of gingival bleeding
- History of trauma
- Presence of fractures, cracks and aesthetic restoration
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bleaching Agentswhitening agent containing fluoride and 40% hydrogen peroxide | Other | Group A |
| Bleaching Agentswhitening agent containing calcium and 35% hydrogen peroxide | Other | Group B |
| Bleaching Agentswhitening agent containing hydroxyapatite and 18% hydrogen peroxide | Other | Group C |
Primary outcome
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Results publication: PubMed 12793212Matis BA. Tray whitening: what the evidence shows. Compend Contin Educ Dent. 2003 Apr;24(4A):354-62.
- Results publication: PubMed 18722039Meireles SS, Heckmann SS, Santos IS, Della Bona A, Demarco FF. A double blind randomized clinical trial of at-home tooth bleaching using two carbamide peroxide concentrations: 6-month follow-up. J Dent. 2008 Nov;36(11):878-84. doi: 10.1016/j.jdent.2008.07.002. Epub 2008 Aug 22.
- Results publication: PubMed 15853099Auschill TM, Hellwig E, Schmidale S, Sculean A, Arweiler NB. Efficacy, side-effects and patients' acceptance of different bleaching techniques (OTC, in-office, at-home). Oper Dent. 2005 Mar-Apr;30(2):156-63.
- Derived from this study: PubMed 42830343Tokat B, Arslan S. Evaluation of tooth sensitivity and whitening effects of tooth whitening agents containing calcium, hydroxyapatite and fluoride. Odontology. 2026 Oct 4. doi: 10.1007/s10266-026-01565-3. Online ahead of print.
- Individual participant dataSharing planned: No. The work is not yet complete
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bleaching Agents in people with Healthy Volunteers and Discoloration of Teeth, run by Betül Tokat at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tooth color within 1 year after whitening (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06855940, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.