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- Essai clinique NCT03621163
Copmere Between Bleaching and Laminate Veneers
Shade Evaluation for Clinical Color Change of Discolored Teeth Treated by Bleaching vs Laminate Veneers.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Dental aesthetics, including tooth color, is of great importance for majority of the people and any discoloration or staining can affect their quality of life negatively1,2. In the UK it has been reported that 28% of grownups are dissatisfied with the appearance of their teeth and in the USA that 34% of grownups population are dissatisfied with their current tooth color. Moreover, in a survey of 3215 subjects from the UK 50% have admitted that they had some kind of tooth discoloration3,4.
Tooth bleaching has become one of the most popular aesthetic dental treatments. Because tooth bleaching is an effective, non-invasive procedure for the change of tooth discoloration, it is the best of treatment options for improving teeth color 5.
Ceramic restorations with excellent biocompatibility are widely used to achieve highly aesthetic characteristics in fixed prosthodontics6. Porcelain laminate veneers have become a popular method of treated tooth discoloration. But are expensive, brittle and difficult to repair7.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Patients included in this clinical trial :
- Men and women between 15and 40 years of age.
- Had good general and oral health.
- The participants needed to have six vital maxillary or mandibular anterior teeth without caries lesions or restorations.
- The maxillary canine was shade A3 or darker as judged by comparison with a shade guide (VITA Classical Shade Guide or Spectrophotometer measurement ).
Exclusion Criteria:
Participants were excluded from the study
- If they presented with anterior restorations; had bruxism habits.
- Were pregnant/lactating; presented with non vital tooth discoloration.
- were taking any drug with anti-inflammatory, analgesic, or antioxidant effect; or presented with recession and dentin exposure
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: bleaching agent
intervention : bleaching agent ( Boost 40%)
|
Opalescence Boost 40% is a 40% hydrogen peroxide, medical power bleaching gel.
The jet mix syringe ensures freshness for each application and precise dosing of the activator.
One barrel contains a unique chemical activation with sodium fluoride and potassium nitrate, which have been demonstrated to reduce caries susceptibility, lower sensitivity, and improve enamel micro-hardness.
The other barrel contains the concentrated hydrogen peroxide.
When mixed, Opalescence Boost results in a 1.1% fluoride and 3% potassium nitrate concentration.
|
|
Comparateur actif: laminate veneers
laminate veneers ( monolithic lithium - silicate)
|
A lithium-silicate glass ceramic is newly introduced to the market.
After crystallization, it demonstrates an ideal combination of strength, aesthetics and translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns.
It differentiated from other ceramics by its high chipping resistance, due to their monolithic composition and average flexural strength of 385 MPa.
Also Milling Block has good wear resistance due to the high content of ultra-fine nano-meter size crystalline structure.
Lithium-silicates ceramic blocks are available in the commonly used VITA Classical and Chromascop Bleach shades.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Color change.
Délai: 1-4 weeks
|
measures the change of color before and after intervention by Easy Shade Spectrophotometry
|
1-4 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Corresponding color with comparator.
Délai: 1-4 weeks
|
by Digital photographs
|
1-4 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Gupta SK, Saxena P. Evaluation of patient satisfaction after non-vital bleaching in traumatized discolored intact anterior teeth. Dent Traumatol. 2014 Oct;30(5):396-399. doi: 10.1111/edt.12109. Epub 2014 Apr 10.
- Gerlach RW, Zhou X. Clinical trial comparing two daytime hydrogen-peroxide professional vital-bleaching systems. Compend Contin Educ Dent. 2004 Aug;25(8 Suppl 2):33-40.
- Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9.
- Mountouris G, Mantzavinos Z, Michou H. [Discolorations: a new method of bleaching discolored vital teeth. (Preliminary study)]. Odontostomatol Proodos. 1990 Jun;44(3):195-206. Greek, Modern.
- Marson FC, Sensi LG, Vieira LC, Araujo E. Clinical evaluation of in-office dental bleaching treatments with and without the use of light-activation sources. Oper Dent. 2008 Jan-Feb;33(1):15-22. doi: 10.2341/07-57.
- Alomari Q, El Daraa E. A randomized clinical trial of in-office dental bleaching with or without light activation. J Contemp Dent Pract. 2010 Jan 1;11(1):E017-24.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
- Maladies stomatognathiques
- Maladies dentaires
- Décoloration des dents
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Inhibiteurs d'enzymes
- Agents tranquillisants
- Médicaments psychotropes
- Agents antidépresseurs
- Agents antimaniaques
- Carbonate de lithium
Autres numéros d'identification d'étude
- DTB&V
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
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