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Active, not recruiting

NCT Number: NCT07781969

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Tooth Discoloration Following Root Canal Treatment Stomatognathic Diseases Tooth Discoloration Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Faculty of Dentistry

Istanbul, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent.

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.

Treatment and study plan

Root canal treatment

Procedure

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

Primary outcomes

  1. Change in Tooth Color (ΔE00)

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

    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.

Secondary outcomes

  1. Change in Tooth Lightness (ΔL*)

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

    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.

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth: A Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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