Shade Matching of Omnichroma (One Shade Universal Composite) Versus a Microhybrid Composite in Class V Restorations.

NCT04129047 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: OPER 3-7-1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Background Resin composites are effective in restoring damaged teeth due to their good esthetics, high surface gloss, and clinically acceptable wear resistance1. One of the most challenging tasks a dentist has to confront in daily practice is matching the color of composite restorations used in anterior teeth2. Problem The shade selection is carried out subjectively with a visual shade guide and generally under inadequate light conditions, which can lead to errors in color perception3. The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.4. Not only that, but there was also mismatch between composite shades and the proprietary shade guides included with the composite kits 5. A mock-up should be performed as a trial to assist in shade selection and ensure the predictability of the esthetic result in restorative treatment6. Rationale Shade matching has been a time consuming procedure. Recommendations were made to make customized shade guides of the used composite material for more predictable results7. Manufacturers have been aiming at providing materials with a blending effect; taking on the color appearance from surrounding tooth structure 8. Introduction of Omnichroma by Tokuyama is aiming at eliminating the shade taking procedure by providing a single shade universal composite that is designed to blend with the surrounding tooth structure without the need for a shade matching procedure. Aim The aim of this study is to evaluate the shade matching ability of a new single shade composite (Omnichroma; Tokuyama) compared to a conventional multiple shade microhybrid composite in the restoration of class V restorations using USPHS criteria

Conditions

Class V Restorations

Outcome Measures

Primary Outcomes (1)

• Shade matching (visually and using image analysis)

  To evaluate the shade matching ability of the newly introduced single shade composite compared to a conventional multiple shade micro hybrid composite. Assessment will be done visually using Modified USPHS Criteria and by image analysis. Image analysis will be done by comparing LAB values using Adobe Photoshop

  Baseline after 1 week

Secondary Outcomes (1)

• Color stability (visually and using image analysis)

  Color stability between baseline, 3 months and 6 months

Study Arms (2)

Omnichroma (one shade universal) composite by Tokuyama

EXPERIMENTAL

class V cavities will be made under isolation. Omnichroma (one shade universal) composite by Tokuyama will be placed according to guidelines.

Drug: Omnichroma (one shade universal) composite by Tokuyama

A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA)

ACTIVE COMPARATOR

class V cavities will be made under isolation. A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA) will be placed according to guidelines.

Drug: A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA

Interventions

Omnichroma (one shade universal) composite by Tokuyama DRUG

Omnichroma is a single shade composite that is intended to have a color blending potential. It eliminates the shade matching procedures and makes it easier to avoid individual errors in shade matching in composite restorations.

Omnichroma (one shade universal) composite by Tokuyama

A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA DRUG

a multiple shade universal composite that needs prior shade selection procedure

A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA)

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with carious class V lesions
• Non-carious cervical abfraction lesions
• Young adult Males or female
• Good oral hygiene
• Co-operative patients approving to participate in the study

You may not qualify if:

• Patients with a compromised medical history.
• Severe or active periodontal disease
• Severe medical complications
• Erosive lesions
• Lack of compliance and rampant caries

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related Publications (17)

• Sakrana AA, Tanoue N, Kawasaki K, Matsumura H. One-year clinical evaluation of two composite materials used for anterior class V restorations. J Oral Rehabil. 2004 Oct;31(10):985-90. doi: 10.1111/j.1365-2842.2004.01333.x.

  PMID: 15387839 BACKGROUND

• Bayne SC, Heymann HO, Swift EJ Jr. Update on dental composite restorations. J Am Dent Assoc. 1994 Jun;125(6):687-701. doi: 10.14219/jada.archive.1994.0113.

  PMID: 8014334 BACKGROUND

• Ferracane JL. Resin composite--state of the art. Dent Mater. 2011 Jan;27(1):29-38. doi: 10.1016/j.dental.2010.10.020. Epub 2010 Nov 18.

  PMID: 21093034 BACKGROUND

• Folwaczny M, Loher C, Mehl A, Kunzelmann KH, Hickel R. Class V lesions restored with four different tooth-colored materials--3-year results. Clin Oral Investig. 2001 Mar;5(1):31-9. doi: 10.1007/s007840000098.

  PMID: 11355096 BACKGROUND

• Fondriest J. Shade matching in restorative dentistry: the science and strategies. Int J Periodontics Restorative Dent. 2003 Oct;23(5):467-79.

  PMID: 14620121 BACKGROUND

• Hall NR, Kafalias MC. Composite colour matching: the development and evaluation of a restorative colour matching system. Aust Prosthodont J. 1991;5:47-52.

  PMID: 1812939 BACKGROUND

• Kim HS, Um CM. Color differences between resin composites and shade guides. Quintessence Int. 1996 Aug;27(8):559-67.

  PMID: 9161260 BACKGROUND

• Lee YK, Yu B, Lee SH, Cho MS, Lee CY, Lim HN. Shade compatibility of esthetic restorative materials--A review. Dent Mater. 2010 Dec;26(12):1119-26. doi: 10.1016/j.dental.2010.08.004. Epub 2010 Sep 15.

  PMID: 20832851 BACKGROUND

• McLaren EA, Figueira J, Goldstein RE. A Technique Using Calibrated Photography and Photoshop for Accurate Shade Analysis and Communication. Compend Contin Educ Dent. 2017 Feb;38(2):106-113.

  PMID: 28156124 BACKGROUND

• Mourouzis P, Koulaouzidou EA, Palaghias G, Helvatjoglu-Antoniades M. Color match of resin composites to intact tooth structure. J Appl Biomater Funct Mater. 2015 Oct 16;13(3):e259-65. doi: 10.5301/jabfm.5000228.

  PMID: 26108430 BACKGROUND

• Narhi TO, Tanner J, Ostela I, Narva K, Nohrstrom T, Tirri T, Vallittu PK. Anterior Z250 resin composite restorations: one-year evaluation of clinical performance. Clin Oral Investig. 2003 Dec;7(4):241-3. doi: 10.1007/s00784-003-0231-6. Epub 2003 Sep 18.

  PMID: 14505071 BACKGROUND

• 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.

  PMID: 16378637 BACKGROUND

• Paravina RD, Kimura M, Powers JM. Color compatibility of resin composites of identical shade designation. Quintessence Int. 2006 Oct;37(9):713-9.

  PMID: 17017633 BACKGROUND

• 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.

  PMID: 31095870 BACKGROUND

• Ruschel VC, Martins MV, Bernardon JK, Maia HP. Color Match Between Composite Resin and Tooth Remnant in Class IV Restorations: A Case Series. Oper Dent. 2018 Sep/Oct;43(5):460-466. doi: 10.2341/17-132-S. Epub 2018 Mar 16.

  PMID: 29547347 BACKGROUND

• Strnad, G. et al. (2015) 'Effect of Curing, Finishing and Polishing Techniques on Microhardness of Composite Restorative Materials', Procedia Technology, 19, pp. 233-238. doi: https://doi.org/10.1016/j.protcy.2015.02.034.

  BACKGROUND

• Tuncer S, Demirci M, Oztas E, Tekce N, Uysal O. Microhybrid versus nanofill composite in combination with a three step etch and rinse adhesive in occlusal cavities: five year results. Restor Dent Endod. 2017 Nov;42(4):253-263. doi: 10.5395/rde.2017.42.4.253. Epub 2017 Aug 21.

  PMID: 29142873 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: October 16, 2019
• Study Start: July 20, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

EG (1)