Color Stability of Darkly Discolored Arrested Caries Lesions Following Bleaching Treatment
1 other identifier
observational
27
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2023
CompletedFirst Submitted
Initial submission to the registry
October 9, 2026
CompletedFirst Posted
Study publicly available on registry
October 21, 2026
CompletedOctober 21, 2026
October 1, 2026
7 months
October 9, 2026
October 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (3)
Change in laser fluorescence (DIAGNODent Pen) values from baseline to 3 months
3 months
Change in ICDAS II codes of DDACL teeth from baseline to 3 months
3 months
Change in participant and clinician color satisfaction score (1-10) from baseline to 3 months
3 months
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Selçuk University Faculty of Dentistry
Konya, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merve Albakır Yiğit, DDS, Specialist
Selçuk University Faculty of Dentistry
- STUDY DIRECTOR
Nevin Çobanoğlu, Prof
Selçuk University Faculty of Dentistry
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist in Restorative Dentistry
Study Record Dates
First Submitted
October 9, 2026
First Posted
October 21, 2026
Study Start
February 10, 2023
Primary Completion
September 21, 2023
Study Completion
September 21, 2023
Last Updated
October 21, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared publicly in order to protect patient privacy. Aggregate results are reported in the published article.