TOOTH DİSCOLORATİON AFTER ROOT CANAL TREATMENT WİTH AH PLUS AND BİOROOT RCS
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Rize, Turquie (Türkiye)
- Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Endodontics
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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. |
|
Expérimental: 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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Tooth Color Measured by CIEDE2000 (ΔE00)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in CIELAB Color Parameters (L*, a*, and b*)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RTEU-ENDO-BA-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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