Tooth Erosion Clinical Trial
Official title:
Clinical Evaluation of Ultrathin Occlusal Veneers for the Treatment of Severe Dental Erosion
Ultra-thin bonded posterior occlusal veneers represent a conservative alternative to traditional onlays and complete coverage crowns for the treatment of severe erosive lesions. Therefore, the purpose of this study is to determine whether ceramic and composite resin ultrathin occlusal veneers (0.6 - 1.0 mm thick) are effective in the rehabilitation of patients affected by moderate and severe dental erosion.
Along with data collection, complete arch polyvinyl siloxane impressions are made to obtain
accurate diagnostic casts. The occlusal relationship is recorded either at the maximum
intercuspal position or centric relation (in cases occlusal space is needed for the
restoration of the palatal of upper anterior teeth). An additive waxing is carried out for
the eroded teeth. The waxed cast is then duplicated and poured with scannable stone.
An average occlusal clearance of 0.4 to 0.6 mm (central groove) to 1.0 to 1.3 mm (cusp tips)
is generated by means of rotary diamond burs for the ultrathin occlusal veneers. A rubber dam
is placed, and all areas of dentin exposure are ground with a coarse diamond rotary
instrument at low speed (1500 rpm) and immediately sealed using a 3-step etch-and-rinse
dentin bonding agent. The additive wax replica is scanned first for correlation (Cerec
Bluecam; Sirona Dental Systems). The prepared teeth are then scanned in the same way.
The teeth are restored using Cerec AC with the Bluecam/MCXL CAD/CAM system (Sirona Dental
Systems). By using the design tools of the software set in Biogeneric Copy, the restorations
are designed by correlating the preparations with the anatomy of the additive waxing. The
ultrathin occlusal veneers are milled either from composite resin blocks (LAVA Ultimate; 3M
ESPE) or ceramic blocks (e.max CAD; Ivoclar Vivadent) and polished mechanically with silicon
carbide-impregnated brushes.
Restorations are then adhesively cemented. After being air-dried, the intaglio surfaces are
silanated and heat dried at 68 oC for 5 minutes (Calset; AdDent Inc). The tooth preparations
are airborne-particle abraded and etched for 30 seconds with 37.5% phosphoric acid, rinsed,
and dried. Adhesive resin (Optibond FL, bottle 2; Kerr Corp) is applied to both fitting
surfaces of the restoration. After the luting material (Filtek Z100; 3M ESPE), preheated to
68oC (in Calset; AdDent), is applied to the tooth, the restorations were individually seated,
followed by the elimination of excess composite resin and initial light polymerization. Each
surface is exposed at 1000 mW/cm2 for 1 minute (20 seconds per surface, repeated 3 times).
Margins are then covered with an air barrier and light polymerized for an additional 20
seconds. Margins are finished and polished at the following appointment with diamond ceramic
polishers and silicon impregnated rubber polishers.
Patients are called for a base line evaluation followed by additional evaluations after 1
year, 2 years and 4 years.
Patients Registries:
Patients' registries are made in paper forms and immediately digitalized for safety. The form
is stored inside an identified folder containing other patient's documents related to the
treatment.
Upon completion of the registry all data is verified by a third person to check for
completeness, calibration and accuracy.
Two researchers linked to the project perform patient recruitment (not the evaluators).
Patients are interviewed and seen for data collection. If eligibility criteria are meet, the
patient receives a comprehensive explanation (accessible language) about the protocol and an
invitation to participate.
Despite evaluators were previously calibrated; detailed description of the criteria (based on
USPHS) is available to the evaluator at every data collection (follow-up appointments).
Patients are seen at clinic of the Department of Prosthodontics and Dental Materials of the
Dental School of UFRJ. During the follow-up appointments data is collected in sequence by two
calibrated evaluators. In case of divergence, a consensus is achieved. Intraoral evaluation
is performed with dental explorer and mouth mirror assisted by dental operatory light as well
as well as a LED transilluminator for crack chasing. In case of failure (cracks longer than 2
mm, lost fragments or bulk debondings) patients are assigned for repair or change of
restoration.
The sample of 5 patients for each group was based on the following formula: n = (Zα/2+Zβ)2 *
(p1(1-p1)+p2(1-p2)) / (p1-p2)2, with a confidence level of 95%, power of 80% and the survival
rates of 90% and 20% for composite and ceramic restorations, respectively (based on previous
published data of in vitro fatigue tests).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02548156 -
Intra Oral Kinetics of Fluoride Containing Dentifrices
|
N/A | |
Completed |
NCT02533466 -
In Vivo Investigation of Initial Stages of Enamel Erosion
|
N/A | |
Completed |
NCT04586322 -
Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.
|
||
Completed |
NCT01622920 -
Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
|
Phase 1 | |
Completed |
NCT00564330 -
In Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole
|
Phase 1/Phase 2 | |
Completed |
NCT03296072 -
In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste
|
Phase 3 | |
Completed |
NCT03101943 -
Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months
|
N/A | |
Completed |
NCT03515902 -
The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity
|
N/A | |
Completed |
NCT05146557 -
Associations Between Obesity, Dental Caries, Erosive Tooth Wear and Periodontal Disease in Adolescents: A Case Control-study
|
||
Completed |
NCT02676219 -
Pilot Study Utilising an Impression Technique to Capture in Vivo Images of Teeth
|
N/A | |
Completed |
NCT03577834 -
The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
|
N/A | |
Completed |
NCT06242444 -
An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel
|
N/A | |
Completed |
NCT01128972 -
Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion
|
Phase 2 | |
Completed |
NCT06136754 -
Investigate a Varnish to Protect From Erosive Toothwear
|
Phase 3 |