Tooth Discoloration Following Root Canal TreatmentNCT07849296
TOOTH DİSCOLORATİON AFTER ROOT CANAL TREATMENT WİTH AH PLUS AND BİOROOT RCS
A study testing AH Plus Root Canal Sealer and BioRoot RCS Root Canal Sealer in people with Tooth Discoloration Following Root Canal Treatment, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration Following Root Canal Treatment
- What is being tested?
- AH Plus Root Canal Sealer and BioRoot RCS Root Canal Sealer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 12 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Endodontics
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About this study
Official title: 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:
Read more
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.
Read the 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).
- Being tested
- AH Plus Root Canal Sealer, BioRoot RCS Root Canal Sealer
- Keywords
- Tooth Discoloration, Root Canal Obturation, Spectrophotometry, Colorimetry, Root Canal Filling Materials
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH Plus Root Canal SealerDevice
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.
BioRoot RCS Root Canal SealerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AH Plus Group | Experimental | 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. Receives: Device: AH Plus Root Canal Sealer |
| BioRoot RCS Group | Experimental | 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. Receives: Device: BioRoot RCS Root Canal Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tooth Color Measured by CIEDE2000 (ΔE00)
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.
Measured: 12 months
Secondary outcomes (1)
Changes in CIELAB Color Parameters (L*, a*, and b*)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start15 Dec 2024
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This was a non-randomized, parallel-group prospective clinical study. Participants were prospectively enrolled, and eligible maxillary anterior teeth were treated using either AH Plus or BioRoot RCS root canal sealer. The same standardized treatment protocol, including cold lateral condensation, was applied in both groups.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Asrak, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849296
- Sponsor's protocol ID
- RTEU-ENDO-BA-01
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07849296
- Acronym / sponsor ID
- RTEU-ENDO-BA-01
- Keywords
- Tooth Discoloration, Root Canal Obturation, Spectrophotometry, Colorimetry, Root Canal Filling Materials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 30 Sep 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a non-randomized, parallel-group prospective clinical study. Participants were prospectively enrolled, and eligible maxillary anterior teeth were treated using either AH Plus or BioRoot RCS root canal sealer. The same standardized treatment protocol, including cold lateral condensation, was applied in both groups.
| Arm | Type | Receives |
|---|---|---|
| AH Plus Group | Experimental | Device: AH Plus Root Canal SealerParticipants 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. |
| BioRoot RCS Group | Experimental | Device: BioRoot RCS Root Canal SealerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Non-vital or necrotic tooth.
- History of dental trauma.
- Internal or external root resorption.
- Previous root canal treatment.
- Previous tooth bleaching treatment.
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 |
|---|---|---|
| AH Plus Root Canal SealerAH 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. | Device | AH Plus Group |
| BioRoot RCS Root Canal SealerBioRoot 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. | Device | BioRoot RCS Group |
Primary outcome
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.
1 secondary outcome
Changes in CIELAB Color Parameters (L*, a*, and b*)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Tooth Discoloration Following Root Canal Treatment
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
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?
A study testing AH Plus Root Canal Sealer and BioRoot RCS Root Canal Sealer in people with Tooth Discoloration Following Root Canal Treatment, run by Recep Tayyip Erdogan 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Measured by CIEDE2000 (ΔE00) (time frame: 12 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 30 Sep 2026.