Claim 1:
Qvist V, Laurberg L, Poulsen A, Teglers PT. Eight-year study on conventional glass ionomer and amalgam restorations in primary teeth. Acta Odontol Scand. 2004 Feb;62(1):37-45.
Lidums A, Wilkie R, Smales R. Occlusal glass ionomer cermet, resin sandwich and amalgam restorations: a 2-year clinical study. Am J Dent. 1993 Aug;6(4):185-8.
Smales RJ, Gerke DC. Clinical behaviour over three years of GS-80 and Lojic+ amalgam alloys. Aust Dent J. 1994 Dec;39(6):344-7.
Dunne SM, Abraham R, Pankhurst CL. A 3-year longitudinal, controlled clinical study of a gallium-based restorative material. Br Dent J. 2005 Mar 26;198(6):355-9; discussion 348.
Soncini JA, Maserejian NN, Trachtenberg F, Tavares M, Hayes C. The longevity of amalgam versus compomer/composite restorations in posterior primary and permanent teeth: findings From the New England Children's Amalgam Trial. J Am Dent Assoc. 2007 Jun;138(6):763-72.
Hung TW, Richardson AS. Clinical evaluation of glass ionomer-silver cermet restorations in primary molars: one year results. J Can Dent Assoc. 1990 Mar;56(3):239-40.
Smales RJ, Gerke DC, Hume WR. Clinical behaviour of high-copper amalgams with time, site, size and class of cavity preparation. J Dent. 1990 Feb;18(1):49-53.
Smales RJ, Gerke DC, White IL. Clinical evaluation of occlusal glass ionomer, resin, and amalgam restorations. J Dent. 1990 Oct;18(5):243-9.
Collins CJ, Bryant RW, Hodge KL. A clinical evaluation of posterior composite resin restorations: 8-year findings. J Dent. 1998 May;26(4):311-7.
Stangel I, Barolet RY. Clinical evaluation of two posterior composite resins: two-year results. J Oral Rehabil. 1990 May;17(3):257-68.
Knibbs PJ, Smart ER. The clinical performance of a posterior composite resin restorative material, Heliomolar R.O.: 3-year report. J Oral Rehabil. 1992 May;19(3):231-7.
Norman RD, Wright JS, Rydberg RJ, Felkner LL. A 5-year study comparing a posterior composite resin and an amalgam. J Prosthet Dent. 1990 Nov;64(5):523-9.
Johnson GH, Bales DJ, Gordon GE, Powell LV. Clinical performance of posterior composite resin restorations. Quintessence Int. 1992 Oct;23(10):705-11.
Claim 2:
Jokstad A, Mjör IA. Analyses of long-term clinical behavior of class-II amalgam restorations. Acta Odontol Scand. 1991 Feb;49(1):47-63.
Qvist V, Laurberg L, Poulsen A, Teglers PT. Eight-year study on conventional glass ionomer and amalgam restorations in primary teeth. Acta Odontol Scand. 2004 Feb;62(1):37-45.
Smales RJ, Gerke DC. Clinical behaviour over three years of GS-80 and Lojic+ amalgam alloys. Aust Dent J. 1994 Dec;39(6):344-7.
Dunne SM, Abraham R, Pankhurst CL. A 3-year longitudinal, controlled clinical study of a gallium-based restorative material. Br Dent J. 2005 Mar 26;198(6):355-9; discussion 348.
Barr-Agholme M, Odén A, Dahllöf G, Modeér T. A two-year clinical study of light-cured composite and amalgam restorations in primary molars. Dent Mater. 1991 Oct;7(4):230-3.
Sachdeo A, Gray GB, Sulieman MA, Jagger DC. Comparison of wear and clinical performance between amalgam, composite and open sandwich restorations: 2-year results. Eur J Prosthodont Restor Dent. 2004 Mar;12(1):15-20.
Hung TW, Richardson AS. Clinical evaluation of glass ionomer-silver cermet restorations in primary molars: one year results. J Can Dent Assoc. 1990 Mar;56(3):239-40.
Smales RJ, Gerke DC, Hume WR. Clinical behaviour of high-copper amalgams with time, site, size and class of cavity preparation. J Dent. 1990 Feb;18(1):49-53.
Mjör IA, Jokstad A. Five-year study of Class II restorations in permanent teeth using amalgam, glass polyalkenoate (ionomer) cerment and resin-based composite materials. J Dent. 1993 Dec;21(6):338-43.
Collins CJ, Bryant RW, Hodge KL. A clinical evaluation of posterior composite resin restorations: 8-year findings. J Dent. 1998 May;26(4):311-7.
Stangel I, Barolet RY. Clinical evaluation of two posterior composite resins: two-year results. J Oral Rehabil. 1990 May;17(3):257-68.
Knibbs PJ, Smart ER. The clinical performance of a posterior composite resin restorative material, Heliomolar R.O.: 3-year report. J Oral Rehabil. 1992 May;19(3):231-7.
Norman RD, Wright JS, Rydberg RJ, Felkner LL. A 5-year study comparing a posterior composite resin and an amalgam. J Prosthet Dent. 1990 Nov;64(5):523-9.
Fuks AB, Araujo FB, Osorio LB, Hadani PE, Pinto AS. Clinical and radiographic assessment of Class II esthetic restorations in primary molars. Pediatr Dent. 2000 Nov-Dec;22(6):479-85.
Kavvadia K, Kakaboura A, Vanderas AP, Papagiannoulis L. Clinical evaluation of a compomer and an amalgam primary teeth class II restorations: a 2-year comparative study. Pediatr Dent. 2004 May-Jun;26(3):245-50.
Johnson GH, Bales DJ, Gordon GE, Powell LV. Clinical performance of posterior composite resin restorations. Quintessence Int. 1992 Oct;23(10):705-11.




Clinical indication(s) / Claim(s)
Verbatim per manufacturer's Instructions-for-use (IFU) sheet
Claim 1: for use in stress bearing restorations (Class 1)
Claim 2: for use in stress bearing restorations (Class 2)
.
Clinical evidence supporting the claim(s)
From full report(s) of prospective, clinical controlled trial(s)
Clinical evidence not supporting the claim(s)
From full report(s) of prospective, clinical controlled trial(s)
Clinical evidence not related to the claim(s)
From full report(s) of prospective, clinical controlled trial(s)
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Mustafa D. Randomised clinical trial of four dental restorative materials. Thesis; 2005.
Osborne JW, Norman RD. 13-year clinical assessment of 10 amalgam alloys. Dent Mater. 1990 Jul;6(3):189-94.
Mertz-Fairhurst EJ, Curtis JW Jr, Ergle JW, Rueggeberg FA, Adair SM. Ultraconservative and cariostatic sealed restorations: results at year 10. J Am Dent Assoc. 1998 Jan;129(1):55-66.
Bernardo M, Luis H, Martin MD, Leroux BG, Rue T, Leitão J, DeRouen TA. Survival and reasons for failure of amalgam versus composite posterior restorations placed in a randomized clinical trial. J Am Dent Assoc. 2007 Jun;138(6):775-83.
Smales RJ. Longevity of low- and high-copper amalgams analyzed by preparation class, tooth site, patient age, and operator. Oper Dent. 1991 Sep-Oct;16(5):162-8.
Johnson GH, Bales DJ, Powell LV. Effect of admixed indium on the clinical success of amalgam restorations. Oper Dent. 1992 Sep-Oct;17(5):196-202.
Wilson MA, Cowan AJ, Randall RC, Crisp RJ, Wilson NH. A practice-based, randomized, controlled clinical trial of a new resin composite restorative: one-year results. Oper Dent. 2002 Sep-Oct;27(5):423-9.
Osborne JW, Norman RD, Gale EN. A 14-year clinical assessment of 12 amalgam alloys. Quintessence Int. 1991 Nov;22(11):857-64.
Navarro MF, Franco EB, Bastos PA, Teixeira LC, Carvalho RM. Clinical evaluation of gallium alloy as a posterior restorative material. Quintessence Int. 1996 May;27(5):315-20.
Chu CH, King NM, Lee AM, Yiu CK, Wei SH. A pilot study of the marginal adaptation and surface morphology of glass-cermet cements. Quintessence Int. 1996 Jul;27(7):493-501.
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