Dental CariesNCT07886255
Color Stability of Darkly Discolored Arrested Caries Lesions Following Bleaching Treatment
An observational study of Dental Caries and Tooth Discoloration, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This observational study evaluated the color stability of darkly discolored arrested caries lesions (DDACL) on anterior teeth following in-office bleaching with 40% hydrogen peroxide, in comparison with healthy teeth. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Tooth Discoloration
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2023to 21 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult patients (18-55 years) attending the Department of Restorative Dentistry, Faculty of Dentistry, Selçuk University, with darkly discolored arrested caries lesions on anterior teeth or with healthy anterior teeth, who were scheduled for in-office bleaching.
Who may be able to join
- Aged between 18 and 55 years
- No missing maxillary or mandibular anterior and premolar teeth
- No restorations, cavitations, or active caries on the facial surface of these teeth
- Able to attend regular follow-up appointments
Who cannot join
- Medically compromised patients
- History of previous bleaching treatment
- Poor oral hygiene
- Cavitated or active caries lesions or restorations on the facial surface of the target teeth
Trial locations and contacts
1 site in 1 country.
About this study
This observational study evaluated the color stability of darkly discolored arrested caries lesions (DDACL) on anterior teeth following in-office bleaching with 40% hydrogen peroxide, in comparison with healthy teeth. Tooth color (spectrophotometer, CIELAB, CIEDE2000), laser fluorescence (DIAGNODent Pen), ICDAS II codes, and patient and clinician color satisfaction were assessed at baseline, immediately after bleaching, and at 1 week and 3 months.
Read the detailed description
A total of 105 teeth with DDACL (21 patients) and 96 healthy teeth (6 patients) were treated with in-office bleaching using 40% hydrogen peroxide (Opalescence Boost) following the routine clinical protocol of the Department of Restorative Dentistry, Selçuk University. All procedures and evaluations were performed by a single clinician. Color was measured with a Vita Easyshade spectrophotometer (L*, a*, b*), and color differences were calculated with the CIEDE2000 formula. Laser fluorescence was measured with DIAGNODent Pen, and caries status was recorded with ICDAS II. Evaluations were performed at baseline (T1), immediately after bleaching (T2), 1 week (T3), and 3 months (T4).
- Conditions
- Dental Caries, Tooth Discoloration
- Keywords
- Arrested caries, Bleaching, Color stability, Laser fluorescence
- Medical subject headings
- Dental Caries, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DDACL group | Patients with darkly discolored arrested caries lesions (DDACL) on anterior teeth who underwent in-office bleaching with 40% hydrogen peroxide. | |
| Healthy teeth group | Patients with healthy anterior teeth who underwent in-office bleaching with 40% hydrogen peroxide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change (CIEDE2000 ΔE00) from baseline to 3 months after bleaching
Tooth color was measured with a Vita Easyshade spectrophotometer (CIELAB L*, a*, b*), and color differences were calculated with the CIEDE2000 formula (ΔE00) between baseline and each follow-up time point (immediately after bleaching, 1 week, and 3 months), separately for DDACL and healthy teeth.
Measured: 3 months
Secondary outcomes (3)
Change in laser fluorescence (DIAGNODent Pen) values from baseline to 3 months
Laser fluorescence values measured with the DIAGNODent Pen on the facial surface of the teeth; higher values indicate greater fluorescence associated with demineralization or discoloration.Measurements were taken at baseline, immediately after bleaching, 1 week, and 3 months.
Measured: 3 months
Change in ICDAS II codes of DDACL teeth from baseline to 3 months
Caries status of DDACL teeth scored according to the International Caries Detection and Assessment System (ICDAS II). Codes were recorded at baseline, immediately after bleaching, 1 week, and 3 months.
Measured: 3 months
Change in participant and clinician color satisfaction score (1-10) from baseline to 3 months
Participant and clinician satisfaction with tooth color, rated on a numerical scale from 1 to 10. Scores were recorded at baseline and at 3 months after bleaching.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start10 Feb 2023
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Albakir Yiğit, Selcuk University
- Investigators
- Merve Albakır Yiğit, DDS, Specialist, Principal investigator, Selçuk University Faculty of DentistryNevin Çobanoğlu, Prof, Study director, Selçuk University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886255
- Sponsor's protocol ID
- 2022/51
- Other IDs
- 2022/51
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly in order to protect patient privacy. Aggregate results are reported in the published article.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Stability of Darkly Discolored Arrested Caries Lesions Following Bleaching Treatment
- ClinicalTrials.gov ID
- NCT07886255
- Acronym / sponsor ID
- 2022/51
- Conditions
- Dental Caries, Tooth Discoloration
- Keywords
- Arrested caries, Bleaching, Color stability, Laser fluorescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 21 Oct 2026 (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.
This observational study evaluated the color stability of darkly discolored arrested caries lesions (DDACL) on anterior teeth following in-office bleaching with 40% hydrogen peroxide, in comparison with healthy teeth. Tooth color (spectrophotometer, CIELAB, CIEDE2000), laser fluorescence (DIAGNODent Pen), ICDAS II codes, and patient and clinician color satisfaction were assessed at baseline, immediately after bleaching, and at 1 week and 3 months.
Detailed description
A total of 105 teeth with DDACL (21 patients) and 96 healthy teeth (6 patients) were treated with in-office bleaching using 40% hydrogen peroxide (Opalescence Boost) following the routine clinical protocol of the Department of Restorative Dentistry, Selçuk University. All procedures and evaluations were performed by a single clinician. Color was measured with a Vita Easyshade spectrophotometer (L*, a*, b*), and color differences were calculated with the CIEDE2000 formula. Laser fluorescence was measured with DIAGNODent Pen, and caries status was recorded with ICDAS II. Evaluations were performed at baseline (T1), immediately after bleaching (T2), 1 week (T3), and 3 months (T4).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDACL group | – | –Patients with darkly discolored arrested caries lesions (DDACL) on anterior teeth who underwent in-office bleaching with 40% hydrogen peroxide. |
| Healthy teeth group | – | –Patients with healthy anterior teeth who underwent in-office bleaching with 40% hydrogen peroxide. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult patients (18-55 years) attending the Department of Restorative Dentistry, Faculty of Dentistry, Selçuk University, with darkly discolored arrested caries lesions on anterior teeth or with healthy anterior teeth, who were scheduled for in-office bleaching.
Key inclusion criteria (4 listed)
- Aged between 18 and 55 years
- No missing maxillary or mandibular anterior and premolar teeth
- No restorations, cavitations, or active caries on the facial surface of these teeth
- Able to attend regular follow-up appointments
Key exclusion criteria (4 listed)
- Medically compromised patients
- History of previous bleaching treatment
- Poor oral hygiene
- Cavitated or active caries lesions or restorations on the facial surface of the target teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Color change (CIEDE2000 ΔE00) from baseline to 3 months after bleaching
Time frame: 3 months
Tooth color was measured with a Vita Easyshade spectrophotometer (CIELAB L*, a*, b*), and color differences were calculated with the CIEDE2000 formula (ΔE00) between baseline and each follow-up time point (immediately after bleaching, 1 week, and 3 months), separately for DDACL and healthy teeth.
3 secondary outcomes
Change in laser fluorescence (DIAGNODent Pen) values from baseline to 3 months
Time frame: 3 months
Change in ICDAS II codes of DDACL teeth from baseline to 3 months
Time frame: 3 months
Change in participant and clinician color satisfaction score (1-10) from baseline to 3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly in order to protect patient privacy. Aggregate results are reported in the published article.
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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.
Merve Albakır Yiğit, DDS, Specialist principal investigator
Selçuk University Faculty of Dentistry
Nevin Çobanoğlu, Prof study director
Selçuk University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Tooth Discoloration, run by Selcuk University 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Color change (CIEDE2000 ΔE00) from baseline to 3 months after bleaching (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.