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

NCT07849296 | Completed

• 1 other identifier: RTEU-ENDO-BA-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tooth Discoloration Following Root Canal Treatment

Keywords

Tooth Discoloration; Root Canal Obturation; Spectrophotometry; Colorimetry; Root Canal Filling Materials

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Changes in CIELAB Color Parameters (L*, a*, and b*)

  12 months

Study Arms (2)

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.

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.

Device: BioRoot RCS Root Canal Sealer

Interventions

AH Plus Root Canal Sealer DEVICE

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.

AH Plus Group

BioRoot RCS Root Canal Sealer DEVICE

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.

BioRoot RCS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Endodontics

Rize, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: December 15, 2024
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)