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

NCT07781969 | Active Not Recruiting

• 2 other identifiers: 2025-09-03/2025-7311962
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Discoloration Following Root Canal Treatment; Tooth Discoloration

Keywords

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

Outcome Measures

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.

  Baseline, 3 months, 6 months, and 9 months

Secondary Outcomes (3)

• Change in Tooth Lightness (ΔL*)

  Baseline, 3 months, 6 months, and 9 months

• Change in Red-Green Color Coordinate (Δa*)

  Baseline, 3 months, 6 months, and 9 months

• Change in Yellow-Blue Color Coordinate (Δb*)

  Baseline, 3 months, 6 months, and 9 months

Study Arms (2)

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

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

Devital Teeth; Vital Teeth

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: September 16, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)