Ireland
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Active, not recruiting Observational

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

NCT07781969 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-09-16
Last updated
2026-08-27

Condition(s) studied

Tooth Discoloration Following Root Canal TreatmentTooth Discoloration

Investigational drug(s) / intervention(s)

Root Canal Treatment

Root 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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • Change in Tooth Color (ΔE00) — 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.

Trial sites (1)

FacilityCityRegionStatus
Marmara University Faculty of Dentistry Istanbul Istanbul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07781969 on ClinicalTrials.gov ↗ ← All trials in Turkey