NCT07886255

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

7 months

First QC Date

October 9, 2026

Last Update Submit

October 17, 2026

Conditions

Keywords

Arrested cariesBleachingColor stabilityLaser fluorescence

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

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

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)

Location

MeSH Terms

Conditions

Dental CariesTooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Merve Albakır Yiğit, DDS, Specialist

    Selçuk University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR
  • Nevin Çobanoğlu, Prof

    Selçuk University Faculty of Dentistry

    STUDY DIRECTOR

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.

Locations