Tooth Discoloration Following Root Canal TreatmentNCT07781969
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
An observational study of Tooth Discoloration Following Root Canal Treatment and Tooth Discoloration, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
- What is being tested?
- Root Canal Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2025to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, Istanbul, 34854
About this study
Official title: Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth: A Prospective Study
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.
- Being tested
- Root Canal Treatment
- Keywords
- Tooth Discoloration, Root Canal Treatment, Spectrophotometry, Dental Color, CIEDE2000, Pulp Vitality
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Canal TreatmentProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, and 9 months
Secondary outcomes (3)
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.
Measured: Baseline, 3 months, 6 months, and 9 months
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.
Measured: Baseline, 3 months, 6 months, and 9 months
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.
Measured: Baseline, 3 months, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start16 Sep 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Discoloration Following Root Canal TreatmentStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781969
- Sponsor's protocol ID
- 2025-09-03/2025-73
- Other IDs
- 11962
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth: A Prospective Study
- ClinicalTrials.gov ID
- NCT07781969
- Acronym / sponsor ID
- 2025-09-03/2025-73
- Keywords
- Tooth Discoloration, Root Canal Treatment, Spectrophotometry, Dental Color, CIEDE2000, Pulp Vitality
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vital Teeth | – | Procedure: Root Canal TreatmentMaxillary 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. |
| Devital Teeth | – | Procedure: Root Canal TreatmentMaxillary 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root Canal TreatmentRoot 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 | Procedure or surgery | Devital Teeth, Vital Teeth |
Primary outcome
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.
3 secondary outcomes
Change in Tooth Lightness (ΔL*)
Time frame: Baseline, 3 months, 6 months, and 9 months
Change in Red-Green Color Coordinate (Δa*)
Time frame: Baseline, 3 months, 6 months, and 9 months
Change in Yellow-Blue Color Coordinate (Δb*)
Time frame: Baseline, 3 months, 6 months, and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Discoloration Following Root Canal Treatment and Tooth Discoloration, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tooth Color (ΔE00) (time frame: Baseline, 3 months, 6 months, and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.