Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07781969
Enrollment
52
Registered
2026-08-24
Start date
2025-09-16
Completion date
2026-10-30
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Discoloration, Tooth Discoloration Following Root Canal Treatment

Keywords

Tooth Discoloration, Root Canal Treatment, Spectrophotometry, Dental Color, CIEDE2000, Pulp Vitality

Brief 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.

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.

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

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Tooth Color (ΔE00)Baseline, 3 months, 6 months, and 9 monthsTooth 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

MeasureTime frameDescription
Change in Tooth Lightness (ΔL*)Baseline, 3 months, 6 months, and 9 monthsChanges 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.
Change in Red-Green Color Coordinate (Δa*)Baseline, 3 months, 6 months, and 9 monthsChanges 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.
Change in Yellow-Blue Color Coordinate (Δb*)Baseline, 3 months, 6 months, and 9 monthsChanges 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026