Clinical trial NCT04846101: Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material
Official title: Evaluation of Shade Matching Capacity of a Single-shade Contemporary Resin Composite in Anterior Restorations
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dental Restoration
Keywords: shade matching, dental material, blending effect
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the main difficulties encountered in esthetic dentistry is the complexity associated with shade matching and layering technique to achieve optimal esthetic outcomes. To ensure an esthetic outcome, an imperceptible match of the color of the restorative material to that of the tooth is of utmost importance. Recently, a new shade matching composite that utilizes "smart chromatic technology", developed by Tokuyama was claimed to be able to capture the structural color of its surroundings teeth. Our main objective is to assess the blending capacity of OMNICHROMA composite material in anterior restorations of patients attending the Jordan University Hospital. Both visual and instrumental measurements will be performed and the differences between the shade of the composite resin and the tooth structure will be measured. In addition, multi chroma composite restorations will be placed for the purpose of comparison (control).

Detailed description: In the present study, the restorations will be placed under rubber dam isolation for moisture control. The cavities will be prepared according to the concepts of minimal invasive dentistry. Prior to placing the composite resin, the margins of the cavities will be finished using ultra fine grit diamond burs·and beveled in a 1-mm area. Deep cavities suspected to be near the pulp be lined with RMGI. Inclusion criteria: class Ill and Class IV carious lesions.

The enamel margins of the cavities will be acid etched for 60s with 37% phosphoric acid and then rinsed thoroughly with water spray. Afterwards, the dentin bonding system will be applied, left undisturbed for 20 s and then excess removed using an air syringe and light cured for 20s. The restorative composite material will be placed in incremental layers, adapted, each layer cured for 40s. After polymerization, the restorations will be finished under profuse water spray using diamonds, Sof-Lex finishing discs and polishers.

All restorations will be placed by one dentist (Pl). Written informed consent will be provided to all participants prior to starting the treatment

Eligibility criteria: Inclusion Criteria:

* Healthy patients
* Patients requiring anterior restorations
* Vital teeth
* Absence of periodontal or pulpal disease
* Patients willing to sign informed consent and returning for follow up

Exclusion Criteria:

* Patients with extensive caries and tooth loss
* Patient with periodontal disease
* Patients with poor oral hygiene and lack of motivation
* Patient with severe extrinsic or intrinsic discolorations

Primary outcomes:
measure: Instrumental Color assessment
timeFrame: 2 years
measure: Visual color assessment
timeFrame: 2 years
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The university ofJordan
Study officials:
References:
citation: Mikhail SS, Schricker SR, Azer SS, Brantley WA, Johnston WM. Optical characteristics of contemporary dental composite resin materials. J Dent. 2013 Sep;41(9):771-8. doi: 10.1016/j.jdent.2013.07.001. Epub 2013 Jul 12.
citation: Paravina RD, Westland S, Kimura M, Powers JM, Imai FH. Color interaction of dental materials: blending effect of layered composites. Dent Mater. 2006 Oct;22(10):903-8. doi: 10.1016/j.dental.2005.11.018. Epub 2005 Dec 27.
citation: Paravina RD, Westland S, Imai FH, Kimura M, Powers JM. Evaluation of blending effect of composites related to restoration size. Dent Mater. 2006 Apr;22(4):299-307. doi: 10.1016/j.dental.2005.04.022. Epub 2005 Aug 8.
citation: Tanaka A, Nakajima M, Seki N, Foxton RM, Tagami J. The effect of tooth age on colour adjustment potential of resin composite restorations. J Dent. 2015 Feb;43(2):253-60. doi: 10.1016/j.jdent.2014.09.007. Epub 2014 Sep 19.
citation: Pereira Sanchez N, Powers JM, Paravina RD. Instrumental and visual evaluation of the color adjustment potential of resin composites. J Esthet Restor Dent. 2019 Sep;31(5):465-470. doi: 10.1111/jerd.12488. Epub 2019 May 16.