TOOTH DİSCOLORATİON AFTER ROOT CANAL TREATMENT WİTH AH PLUS AND BİOROOT RCS

September 24, 2026 updated by: Betül Asrak, Recep Tayyip Erdogan University

COMPARİSON OF CHANGES İN TOOTH COLOR OVER TİME FOLLOWİNG ROOT CANAL TREATMENT WİTH AH PLUS AND BİOROOT RCS: A ONE-YEAR PROSPECTİVE CLİNİCAL FOLLOW-UP STUDY

he purpose of this clinical study is to compare tooth color changes after root canal treatment using two different root canal sealers, AH Plus and BioRoot RCS, in upper front teeth.

The main questions this study aims to answer are:

Does the amount of tooth color change differ between teeth treated with AH Plus and those treated with BioRoot RCS? Does tooth color change over time or differ between the cervical, middle, and incisal regions of the tooth crown?

Researchers will compare 66 upper front teeth requiring root canal treatment. Thirty-three teeth will be treated using AH Plus and 33 teeth using BioRoot RCS. Both groups will receive the same root canal treatment protocol, including the cold lateral condensation technique.

Participants will:

Receive root canal treatment in one visit. Have the color of the treated tooth measured before treatment. Return for color measurements at 1 week, 1 month, 3 months, 6 months, and 12 months after treatment.

Tooth color will be measured with a digital device called a spectrophotometer. Measurements will be taken from three areas of the tooth crown to determine how tooth color changes during the one-year follow-up period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tooth color was evaluated using a VITA Easyshade Advance 4.0 digital spectrophotometer. Color measurements were performed by two examiners using the same standardized measurement protocol. Measurements were obtained from the cervical, middle, and incisal regions of the buccal surface of each tooth before root canal treatment and at 1 week, 1 month, 3 months, 6 months, and 12 months after treatment.

At each assessment, CIELAB L*, a*, and b* color values were recorded. Color change from baseline was calculated using the CIEDE2000 color difference formula (ΔE00). The cervical, middle, and incisal regions were evaluated separately to determine whether tooth discoloration differed according to the root canal sealer used, follow-up time, and coronal measurement region.

The reproducibility of the color measurement protocol was assessed through intraobserver and interobserver agreement analyses. These assessments were performed on the contralateral homologous teeth of the same participants, rather than on a separate group of patients. For interobserver agreement, color measurements were performed by two examiners using the same standardized protocol. For intraobserver agreement, the measurements were repeated by the same examiner after a four-week interval. Intraobserver and interobserver agreement were evaluated using the intraclass correlation coefficient (ICC).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Rize, Turkey (Türkiye)
        • Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Endodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Permanent and vital maxillary anterior tooth requiring primary root canal treatment.
  • Single-rooted and single-canaled tooth.
  • Complete root development.
  • No coronal restoration that could affect baseline color measurement.
  • No evident pre-existing tooth discoloration that could affect baseline color measurement.
  • Willingness to participate in the study and attend all scheduled follow-up visits.

Exclusion Criteria:

  • Non-vital or necrotic tooth.
  • History of dental trauma.
  • Internal or external root resorption.
  • Previous root canal treatment.
  • Previous tooth bleaching treatment.
  • Extensive coronal restoration.
  • Veneer or full-crown restoration.
  • Structural enamel or dentin defects that could affect baseline color assessment.
  • Inability or unwillingness to comply with the scheduled follow-up visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AH Plus Group

Participants in this group received primary root canal treatment using AH Plus, an epoxy resin-based root canal sealer. Root canal obturation was completed using the cold lateral condensation technique according to the standardized study protocol.
Device: AH Plus Root Canal Sealer

AH Plus, an epoxy resin-based root canal sealer, was mixed in equal proportions according to the manufacturer's instructions. A thin layer of the sealer was applied to the master gutta-percha cone, and root canal obturation was completed using the cold lateral condensation technique.
Experimental: BioRoot RCS Group

Participants in this group received primary root canal treatment using BioRoot RCS, a calcium silicate-based root canal sealer. Root canal obturation was completed using the cold lateral condensation technique according to the standardized study protocol.
Device: BioRoot RCS Root Canal Sealer

BioRoot RCS, a calcium silicate-based root canal sealer, was prepared according to the manufacturer's instructions by mixing one scoop of powder with five drops of liquid for 60 seconds. The sealer was applied to the master gutta-percha cone, and root canal obturation was completed using the cold lateral condensation technique.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Tooth Color Measured by CIEDE2000 (ΔE00)
Time Frame: 12 months

Tooth color was measured using a VITA Easyshade Advance 4.0 spectrophotometer at the cervical, middle, and incisal regions. CIELAB L*, a*, and b* values were recorded, and the overall color difference from baseline was calculated using the CIEDE2000 formula (ΔE00). Higher ΔE00 values indicate a greater overall color change.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in CIELAB Color Parameters (L*, a*, and b*)
Time Frame: 12 months

Changes in the CIELAB color parameters L*, a*, and b* from baseline were evaluated separately at the cervical, middle, and incisal regions. L* represents lightness, a* represents the red-green axis, and b* represents the yellow-blue axis.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Recep Tayyip Erdogan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RTEU-ENDO-BA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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