دورية أكاديمية
أعرض في EDS

Two-year clinical and radiographic evaluation of ACTIVA BioACTIVE versus Compomer (Dyract® eXtra) in the restoration of class-2 cavities of primary molars: a non-inferior split-mouth randomised clinical trial.

التفاصيل البيبلوغرافية
العنوان: Two-year clinical and radiographic evaluation of ACTIVA BioACTIVE versus Compomer (Dyract® eXtra) in the restoration of class-2 cavities of primary molars: a non-inferior split-mouth randomised clinical trial.
المؤلفون: Banon R; Paediatric Dentistry, Oral Health Sciences, ELOHA (Equal Lifelong Oral Health for All) research group, Ghent University Hospital, Ghent, Belgium. Reda.Banon@gmail.com., Vandenbulcke J; Paediatric Dentistry, Oral Health Sciences, ELOHA (Equal Lifelong Oral Health for All) research group, Ghent University Hospital, Ghent, Belgium., Van Acker J; Paediatric Dentistry, Oral Health Sciences, ELOHA (Equal Lifelong Oral Health for All) research group, Ghent University Hospital, Ghent, Belgium., Martens L; Paediatric Dentistry, Oral Health Sciences, ELOHA (Equal Lifelong Oral Health for All) research group, Ghent University Hospital, Ghent, Belgium., De Coster P; Department of Reconstructive Dentistry and Oral Biology, Oral Health Sciences, Ghent University Hospital, Ghent, Belgium., Rajasekharan S; Paediatric Dentistry, Oral Health Sciences, ELOHA (Equal Lifelong Oral Health for All) research group, Ghent University Hospital, Ghent, Belgium.
المصدر: BMC oral health [BMC Oral Health] 2024 Apr 10; Vol. 24 (1), pp. 437. Date of Electronic Publication: 2024 Apr 10.
نوع المنشور: Randomized Controlled Trial; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101088684 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6831 (Electronic) Linking ISSN: 14726831 NLM ISO Abbreviation: BMC Oral Health Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2001-
مواضيع طبية MeSH: Compomers* , Dental Caries*/diagnostic imaging , Dental Caries*/therapy, Child ; Humans ; Child, Preschool ; Composite Resins ; Dental Restoration, Permanent ; Molar/diagnostic imaging
مستخلص: Objectives: The trial aimed to compare the clinical performance and radiographic success of ACTIVA BioACTIVE versus Compomer in restoring class-II cavities of primary molars.
Materials and Methods: A non-inferior split-mouth design was considered. A pre-calculated sample size of 96 molars (48 per group) with class-2 cavities of twenty-one children whose ages ranged from 5 to 10 years were randomly included in the trial. Pre-operative Plaque Index (PI), DMFT/dmft scores and the time required to fill the cavity were recorded. Over 24 months, the teeth were clinically evaluated every six months and radiographically every 12 months by two calibrated and blinded evaluators using the United States public health service (USPHS)-Ryge criteria. The two-sided 95% confidence interval (CI) for the difference in success rate was considered to assess non-inferiority, and the margin was set at -18%. The linear mixed model and Firth's logistic regression model were used for data analysis (P < 0.05).
Results: After 24 months, 86 teeth (43 per group) were evaluated. The mean PI score was 1.1(± 0.9), while DMFT/dmft was 0.35 (± 0.74) and 6.55 (± 2.25) respectively. The clinical and radiographic success rate of Dyract vs. ACTIVA was 95.3% and 88.3% vs. 93% and 86%, respectively. The two-sided 95% CI for the difference in success rate (-2.3%) was - 3.2 to 1.3% and didn't reach the predetermined margin of -18% which had been anticipated as the non-inferiority margin. Clinically, ACTIVA had a significantly better colour match (P = 0.002) but worse marginal discolouration (P = 0.0143). There were no significant differences regarding other clinical or radiographic criteria (P > 0.05). ACTIVA took significantly less placement time than Dyract, with a mean difference of 2.37 (± 0.63) minutes (P < 0.001).
Conclusion: The performance of ACTIVA was not inferior to Dyract and both materials had a comparable high clinical and radiographic performance in children with high-caries experience. ACTIVA had a significantly better colour match but more marginal discolouration. It took significantly less time to be placed in the oral cavity.
Trial Registration: The study was registered at ClinicalTrials.gov on 4 May 2018 (#NCT03516838).
(© 2024. The Author(s).)
References: Eur Arch Paediatr Dent. 2021 Dec;22(6):1003-1013. (PMID: 34046871)
Eur J Dent. 2018 Jan-Mar;12(1):57-66. (PMID: 29657526)
J Contemp Dent Pract. 2018 Jan 1;19(1):13-19. (PMID: 29358529)
Eur J Orthod. 2013 Dec;35(6):783-9. (PMID: 23376899)
J Taibah Univ Med Sci. 2022 Feb 01;17(4):640-647. (PMID: 35983447)
J Clin Pediatr Dent. 2022 Nov;46(6):25-32. (PMID: 36624901)
Br Dent J. 2002 Sep 28;193(6):339-42. (PMID: 12368893)
Dent Mater. 2019 Dec;35(12):1757-1768. (PMID: 31699444)
Am J Dent. 1998 Jun;11(3):143-8. (PMID: 9823078)
Dent Mater. 2007 May;23(5):615-22. (PMID: 16790271)
J Conserv Dent. 2019 Jan-Feb;22(1):92-96. (PMID: 30820090)
Clin Oral Investig. 2019 Jan;23(1):221-233. (PMID: 29594349)
Dent Mater J. 2011;30(3):374-83. (PMID: 21597206)
Oper Dent. 2000 Jul-Aug;25(4):259-64. (PMID: 11203828)
J Am Dent Assoc. 2023 Feb;154(2):e1-e98. (PMID: 36610925)
Int J Paediatr Dent. 2018 Mar;28(2):123-139. (PMID: 29322626)
BMC Oral Health. 2021 Jan 19;21(1):33. (PMID: 33468122)
Clin Oral Investig. 2022 Mar;26(3):2281-2297. (PMID: 35031879)
Children (Basel). 2022 Mar 19;9(3):. (PMID: 35327805)
J Dent. 2019 Jun;85:93-102. (PMID: 31100332)
Compend Contin Educ Dent. 2015 Jan;36(1):60-5. (PMID: 25822408)
J Dent. 2014 Jul;42(7):793-9. (PMID: 24769385)
Am J Dent. 2001 Jun;14(3):148-52. (PMID: 11572292)
Braz Oral Res. 2018 Mar 01;32:e10. (PMID: 29513886)
Biomaterials. 1998 Mar;19(6):529-39. (PMID: 9645559)
J Int Soc Prev Community Dent. 2022 Aug 29;12(4):418-425. (PMID: 36312581)
Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. (PMID: 27672245)
Pediatr Dent. 1999 Jul-Aug;21(4):231-4. (PMID: 10436476)
J Am Dent Assoc. 1997 Aug;128(8):1088-96. (PMID: 9260418)
J Dent. 1993 Apr;21(2):67-73. (PMID: 8473594)
Int J Surg. 2012;10(1):28-55. (PMID: 22036893)
Biomater Investig Dent. 2019 Dec 12;6(1):90-98. (PMID: 31998876)
Int J Clin Pediatr Dent. 2015 May-Aug;8(2):108-13. (PMID: 26379377)
J Dent Res Dent Clin Dent Prospects. 2015 Spring;9(2):92-5. (PMID: 26236434)
Acta Odontol Scand. 1964 Feb;22:121-35. (PMID: 14158464)
Eur J Oral Sci. 2004 Apr;112(2):188-96. (PMID: 15056118)
BMC Med Res Methodol. 2014 May 11;14:64. (PMID: 24886043)
Dent Mater. 2017 Apr;33(4):e186-e203. (PMID: 28196604)
Eur J Dent. 2019 Oct;13(4):599-606. (PMID: 31891976)
Dent Mater. 2019 Feb;35(2):335-343. (PMID: 30527586)
Pediatr Dent. 2001 Jan-Feb;23(1):24-7. (PMID: 11242726)
Caries Res. 1999 Sep-Oct;33(5):387-92. (PMID: 10460963)
Biometrics. 1977 Mar;33(1):159-74. (PMID: 843571)
Acta Odontol Scand. 1997 Aug;55(4):255-60. (PMID: 9298168)
J Esthet Dent. 2000;12(5):258-63. (PMID: 11338492)
J Indian Soc Pedod Prev Dent. 2022 Jul-Sep;40(3):288-296. (PMID: 36260470)
Clin Oral Investig. 2023 Feb;27(2):541-557. (PMID: 36222961)
Pediatr Dent. 2007 Jan-Feb;29(1):8-15. (PMID: 18041507)
Med Princ Pract. 2010;19(2):148-52. (PMID: 20134179)
فهرسة مساهمة: Keywords: Bioactive material; Bulk-fill composite; Primary molars
سلسلة جزيئية: ClinicalTrials.gov NCT03516838
المشرفين على المادة: 0 (Dyract)
0 (Compomers)
0 (Composite Resins)
تواريخ الأحداث: Date Created: 20240410 Date Completed: 20240412 Latest Revision: 20240425
رمز التحديث: 20240425
مُعرف محوري في PubMed: PMC11005273
DOI: 10.1186/s12903-024-04132-w
PMID: 38600533
قاعدة البيانات: MEDLINE
الوصف
تدمد:1472-6831
DOI:10.1186/s12903-024-04132-w