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Active, not recruitingNCT07781969Updated Aug 27, 2026

Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth

An observational study in Tooth Discoloration Following Root Canal Treatment and Tooth Discoloration, sponsored by Marmara University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Marmara University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Tooth Discoloration with a site in Turkey — 2 open to participants now, 5 under way, none of them phase 3. Tooth Discoloration · Turkey.

Started
2025
with 1 other
Observational
4 of 17
1 open now
Registered
15th of 17
by date
Lead sponsor
3 of 17
Marmara University

Among the 17 studies in Tooth Discoloration with a site in Turkey, this one is one of 2 that started in 2025, is one of 4 observational ones, and was the 15th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

No phase12 · 1 open
Observationalthis study4 · 1 open
Phase 41 · 0 open

By the year they started

First in 2016; this study’s year is marked. 2 started in 2025.

Size and results

Median enrollment 55 across the 13 interventional studies, 42 across the 4 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 17 studies in Tooth Discoloration with a site in Turkey, or all of them as a file.
02

Study summary

This prospective observational study aims to evaluate and compare tooth discoloration following root canal treatment in vital and devital teeth. Patients with maxillary premolar teeth requiring root canal treatment are included in the study. Before treatment, the teeth are classified as vital or devital based on their pulpal status. All teeth receive root canal treatment and coronal restoration using a standardized clinical protocol. Tooth color is objectively measured with a spectrophotometer before treatment and at 3, 6, and 9 months after treatment. Changes in tooth color over time are evaluated and compared between vital and devital teeth.

Read the detailed description

This prospective, single-center observational study is designed to investigate whether the preoperative pulpal status of a tooth is associated with the degree of discoloration occurring after root canal treatment.

Maxillary first and second premolar teeth requiring primary root canal treatment are evaluated clinically and radiographically. Before treatment, pulpal status is assessed using electric pulp testing and cold testing, and the teeth are classified as vital or devital according to the findings. Root canal treatment and coronal restoration are performed by the same operator using a standardized clinical protocol to minimize treatment-related variability.

Tooth color is assessed objectively using a VITA Easyshade V spectrophotometer under standardized conditions. At each assessment, three consecutive measurements are obtained from the middle third of the buccal surface, and the mean values are recorded. Changes in tooth color are evaluated throughout the follow-up period to determine the extent and progression of discoloration and to compare the color changes between vital and devital teeth.

03

Conditions studied

  • Tooth Discoloration Following Root Canal Treatment
  • Tooth Discoloration

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Keywords

  • Tooth Discoloration
  • Root Canal Treatment
  • Spectrophotometry
  • Dental Color
  • CIEDE2000
  • Pulp Vitality
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting to the Department of Endodontics, Faculty of Dentistry, Marmara University, with maxillary first or second premolar teeth requiring root canal treatment constitute the study population. Eligible participants are evaluated clinically and radiographically according to predefined eligibility criteria. Before treatment, pulpal status is assessed using electric pulp testing and cold testing, and the included teeth are classified as vital or devital based on the findings.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 18 to 65 years.
  • Systemically healthy individuals.
  • Patients with maxillary premolar teeth requiring root canal treatment.
  • Individuals who agree to participate in the study and provide written .

Exclusion criteria

Exclusion Criteria:

  • Teeth considered non-restorable.
  • Teeth with full-coverage crown restorations.
  • Teeth that have previously undergone root canal treatment.
  • Patients with a history of medication use that may cause tooth discoloration.
  • Teeth with restorations or caries involving more than two surfaces.
  • Teeth with restorations, caries, or loss of tooth structure involving the buccal surface.
  • Teeth with incomplete root development.
  • Teeth with developmental anomalies.
  • Teeth with a history of dental trauma.
  • Teeth with internal or external root resorption.
  • Teeth with advanced periodontal destruction.
  • Individuals consuming more than two cups per day of coffee, tea, wine, or fruit juices that may cause tooth discoloration.
  • Teeth with amalgam restorations.
  • Current smokers.
  • Pregnant or breastfeeding women.
  • Individuals younger than 18 years or older than 65 years.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • Vital Teeth

    Maxillary first and second premolar teeth requiring primary root canal treatment and classified as vital based on preoperative pulpal status assessed using electric pulp testing and cold testing.

    Procedure: Root Canal Treatment

  • Devital Teeth

    Maxillary first and second premolar teeth requiring primary root canal treatment and classified as devital based on preoperative pulpal status assessed using electric pulp testing and cold testing.

    Procedure: Root Canal Treatment

Interventions

  • ProcedureRoot Canal Treatment

    Root canal treatment is performed in a single visit by the same operator using a standardized clinical protocol. Following local anesthesia and rubber dam isolation, an access cavity is prepared and the working length is determined using an electronic apex locator and confirmed with periapical radiography. Root canals are prepared using a nickel-titanium rotary instrumentation system. Sodium hypochlorite (NaOCl) is used during instrumentation, followed by a final irrigation protocol with 17% ethylenediaminetetraacetic acid (EDTA) and 2.5% NaOCl with irrigant activation. The canals are subsequently dried with sterile paper points. Root canal obturation is performed in the same visit using gutta-percha and AH Plus root canal sealer with the cold lateral condensation technique. After obturation, excess gutta-percha is removed and the coronal level of the root canal filling is standardized at approximately 2 mm apical to the cementoenamel junction. Residual root canal sealer is removed fr

06

What researchers measure

Primary outcomes

  1. Change in Tooth Color (ΔE00)

    Tooth color is objectively assessed using a VITA Easyshade V spectrophotometer. CIELAB L\*, a\*, and b\* values are recorded from the middle third of the buccal surface of each tooth. Three consecutive measurements are obtained at each assessment, and the mean values are used for analysis. Overall tooth color change between baseline and each follow-up time point is calculated using the CIEDE2000 color difference formula (ΔE00). Higher ΔE00 values indicate a greater magnitude of color difference. Changes in ΔE00 are compared between vital and devital teeth.

    Time frame: Baseline, 3 months, 6 months, and 9 months

Secondary outcomes

  1. Change in Tooth Lightness (ΔL*)

    Changes in tooth lightness are assessed using the CIELAB L\* coordinate obtained with a VITA Easyshade V spectrophotometer. ΔL\* is calculated as the difference in L\* values between measurement time points. Positive ΔL\* values indicate an increase in lightness, whereas negative ΔL\* values indicate a decrease in lightness (darkening). ΔL\* is calculated for baseline to 3 months, baseline to 6 months, baseline to 9 months, 3 to 6 months, 3 to 9 months, and 6 to 9 months. ΔL\* values are compared between vital and devital teeth.

    Time frame: Baseline, 3 months, 6 months, and 9 months

  2. Change in Red-Green Color Coordinate (Δa*)

    Changes in the red-green color coordinate are assessed using CIELAB a\* values obtained with a VITA Easyshade V spectrophotometer. Δa\* is calculated as the difference in a\* values between measurement time points. Positive Δa\* values indicate a shift toward red, whereas negative Δa\* values indicate a shift toward green. Δa\* is calculated for baseline to 3 months, baseline to 6 months, baseline to 9 months, 3 to 6 months, 3 to 9 months, and 6 to 9 months. Δa\* values are compared between vital and devital teeth.

    Time frame: Baseline, 3 months, 6 months, and 9 months

  3. Change in Yellow-Blue Color Coordinate (Δb*)

    Changes in the yellow-blue color coordinate are assessed using CIELAB b\* values obtained with a VITA Easyshade V spectrophotometer. Δb\* is calculated as the difference in b\* values between measurement time points. Positive Δb\* values indicate a shift toward yellow, whereas negative Δb\* values indicate a shift toward blue. Δb\* is calculated for baseline to 3 months, baseline to 6 months, baseline to 9 months, 3 to 6 months, 3 to 9 months, and 6 to 9 months. Δb\* values are compared between vital and devital teeth.

    Time frame: Baseline, 3 months, 6 months, and 9 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations. Study results will be reported in an aggregated and anonymized form.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2025 (actual). Primary completion is estimated for Oct 2026, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 24, 2026
StartActual
Sep 16, 2025
Primary completionEst.
Oct 30, 2026
CompletionEst.
Oct 30, 2026
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07781969
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Sep 16, 2025
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Aug 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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