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BMC Oral Health

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Open Access 01-12-2024 | Caries | Research

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

Authors: Reda Banon, Jeroen Vandenbulcke, Jakob Van Acker, Luc Martens, Peter De Coster, Sivaprakash Rajasekharan

Published in: BMC Oral Health | Issue 1/2024

Abstract

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).

Rocha Gomes Torres C, Rego HM, Perote LC, et al. A split-mouth randomized clinical trial of conventional and heavy flowable composites in class II restorations. J Dent. 2014;42:793–9. https://doi.org/10.1016/j.jdent.2014.04.009.CrossRefPubMed

Delgado AHS, Jamal H, Young A, et al. Scoping review of trials evaluating adhesive strategies in pediatric dentistry: where do simplified strategies lie? BMC Oral Health. 2021;21:33. https://doi.org/10.1186/s12903-021-01395-5.CrossRefPubMedPubMedCentral

Siokis V, Michailidis T, Kotsanos N. Tooth-coloured materials for class II restorations in primary molars: systematic review and meta-analysis. Eur Arch Paediatr Dent. 2021;22:1003–13. https://doi.org/10.1007/s40368-021-00632-3.CrossRefPubMed

Meyer JM, Cattani-Lorente MA, Dupuis V. Compomers: between glass-ionomer cements and composites. Biomaterials. 1998;19:529–39. https://doi.org/10.1016/S0142-9612(97)00133-6.CrossRefPubMed

Andersson-Wenckert IE, Folkesson UH, van Dijken JW. Durability of a polyacid-modified composite resin (compomer) in primary molars. A multicenter study. Acta Odontol Scand. 1997;55:255–60. https://doi.org/10.3109/00016359709115424.CrossRefPubMed

Hse KM, Wei SH. Clinical evaluation of compomer in primary teeth: 1-year results. J Am Dent Assoc. 1997;128:1088–96. https://doi.org/10.5353/th_b3195402.CrossRefPubMed

Roeters JJ, Frankenmolen F, Burgersdijk RC, et al. Clinical evaluation of Dyract in primary molars: 3-year results. Am J Dent. 1998;11:143–8.PubMed

Marks LA, Weerheijm KL, van Amerongen WE, et al. Dyract versus Tytin Class II restorations in primary molars: 36 months evaluation. Caries Res. 1999;33:387–92. https://doi.org/10.1159/000016538.CrossRefPubMed

Papagiannoulis L, Kakaboura A, Pantaleon F, et al. Clinical evaluation of a polyacid-modified resin composite (compomer) in class II restorations of primary teeth: a two-year follow-up study. Pediatr Dent. 1999;21:231–4.PubMed

10.

Attin T, Opatowski A, Meyer C, et al. Class II restorations with a polyacid-modified composite resin in primary molars placed in a dental practice: results of a two-year clinical evaluation. Oper Dent. 2000;25:259–64.PubMed

11.

Attin T, Opatowski A, Meyer C, et al. Three-year follow up assessment of class II restorations in primary molars with a polyacid-modified composite resin and a hybrid composite. Am J Dent. 2001;14:148–52.PubMed

12.

Gross LC, Griffen AL, Casamassimo PS. Compomers as class II restorations in primary molars. Pediatr Dent. 2001;23:24–7.PubMed

13.

Duggal MS, Toumba KJ, Sharma NK. Clinical performance of a compomer and amalgam for the interproximal restoration of primary molars: a 24-month evaluation. Br Dent J. 2002;193:339–42. https://doi.org/10.1038/sj.bdj.4801560.CrossRefPubMed

14.

Qvist V, Laurberg L, Poulsen A, et al. Class II restorations in primary teeth: 7-year study on three resin-modified glass ionomer cements and a compomer. Eur J Oral Sci. 2004;112:188–96. https://doi.org/10.1111/j.1600-0722.2004.00117.x.CrossRefPubMed

15.

Toh SL, Messer LB. Evidence-based assessment of tooth-colored restorations in proximal lesions of primary molars. Pediatr Dent. 2007;29:8–15.PubMed

16.

Ertugrul F, Cogulu D, Ozdemir Y, et al. Comparison of conventional versus colored compomers for class II restorations in primary molars: a 12-month clinical study. Med Princ Pract. 2010;19:148–52. https://doi.org/10.1159/000273077.CrossRefPubMed

17.

Ghaderi F, Mardani A. Clinical success rate of Compomer and Amalgam Class II restorations in First Primary molars: a two-year study. J Dent Res Dent Clin Dent Prospects. 2015;9:92–5. https://doi.org/10.15171/joddd.2015.018.CrossRefPubMedPubMedCentral

18.

Chisini LA, Collares K, Cademartori MG, et al. Restorations in primary teeth: a systematic review on survival and reasons for failures. Int J Paediatr Dent. 2018;28:123–39. https://doi.org/10.1111/ipd.12346.CrossRefPubMed

19.

Pires CW, Pedrotti D, Lenzi TL, et al. Is there a best conventional material for restoring posterior primary teeth? A network meta-analysis. Braz Oral Res. 2018;32:e10. https://doi.org/10.1590/1807-3107bor-2018.vol32.0010.CrossRefPubMed

20.

Yeolekar TS, Chowdhary NR, Mukunda KS, et al. Evaluation of Microleakage and marginal Ridge fracture resistance of primary molars restored with three restorative materials: a comparative in vitro study. Int J Clin Pediatr Dent. 2015;8:108–13. https://doi.org/10.5005/jp-journals-10005-1294.CrossRefPubMedPubMedCentral

21.

Bhatia K, Nayak R, Ginjupalli K. Comparative evaluation of a bioactive restorative material with resin modified glass ionomer for calcium-ion release and shear bond strength to dentin of primary teeth-an in vitro study. J Clin Pediatr Dent. 2022;46:25–32. https://doi.org/10.22514/jocpd.2022.022.CrossRefPubMed

22.

Pilcher L, Pahlke S, Urquhart O, et al. Direct materials for restoring caries lesions: systematic review and meta-analysis-a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2023;46:25–32. https://doi.org/10.1016/j.adaj.2022.09.012.CrossRef

23.

Veloso SRM, Lemos CAA, de Moraes SLD, et al. Clinical performance of bulk-fill and conventional resin composite restorations in posterior teeth: a systematic review and meta-analysis. Clin Oral Investig. 2019;23:221–33. https://doi.org/10.1007/s00784-018-2429-7.CrossRefPubMed

24.

Loguercio AD, Rezende M, Gutierrez MF, et al. Randomized 36-month follow-up of posterior bulk-filled resin composite restorations. J Dent. 2019;85:93–102. https://doi.org/10.1016/j.jdent.2019.05.018.CrossRefPubMed

25.

Kunz PVM, Wambier LM, Kaizer MDR, et al. Is the clinical performance of composite resin restorations in posterior teeth similar if restored with incremental or bulk-filling techniques? A systematic review and meta-analysis. Clin Oral Investig. 2022;26:2281–97. https://doi.org/10.1007/s00784-021-04337-1.CrossRefPubMed

26.

De Caluwe T, Vercruysse CW, Ladik I, et al. Addition of bioactive glass to glass ionomer cements: Effect on the physico-chemical properties and biocompatibility. Dent Mater. 2017;33:e186–203. https://doi.org/10.1016/j.dental.2017.01.007.CrossRefPubMed

27.

Alrahlah A. Diametral Tensile Strength, Flexural Strength, and Surface Microhardness of Bioactive Bulk fill restorative. J Contemp Dent Pract. 2018;19:13–9. https://doi.org/10.5005/jp-journals-10024-2205.CrossRefPubMed

28.

Sajini SI, Alshawi BA, Alharbi LM. Assessment of remineralisation potentials of bioactive dental composite using an in-vitro demineralised dentine model. J Taibah Univ Med Sc. 2022;17:640–7. https://doi.org/10.1016/j.jtumed.2021.12.004.CrossRef

29.

Tiskaya M, Al-Eesa NA, Wong FSL, et al. Characterization of the bioactivity of two commercial composites. Dent Mater. 2019;35:1757–68. https://doi.org/10.1016/j.dental.2019.10.004.CrossRefPubMed

30.

Croll TP, Berg JH, Donly KJ. Dental repair material: a resin-modified glass-ionomer bioactive ionic resin-based composite. Compend Contin Educ Dent. 2015;36:60–5.PubMed

31.

Lardani L, Derchi G, Marchio V, et al. One-year clinical performance of Activa Bioactive-Restorative Composite in primary molars. Child (Basel). 2022;9:433. https://doi.org/10.3390/children9030433.CrossRef

32.

Deepika U, Sahoo PK, Dash JK, et al. Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: a randomized, parallel-group, and split-mouth controlled clinical study. J Indian Soc Pedod Prev Dent. 2022;40:288–96. https://doi.org/10.4103/jisppd.jisppd_139_22.CrossRefPubMed

33.

Bhadra D, Shah NC, Rao AS, et al. A 1-year comparative evaluation of clinical performance of nanohybrid composite with activa bioactive composite in Class II carious lesion: a randomized control study. J Conserv Dent. 2019;22:92–6. https://doi.org/10.4103/JCD.JCD_511_18.CrossRefPubMedPubMedCentral

34.

Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28–55. https://doi.org/10.1016/j.ijsu.2011.10.001.CrossRefPubMed

35.

Gugnani N, Pandit IK, Srivastava N, et al. International Caries Detection and Assessment System (ICDAS): a New Concept. Int J Clin Pediatr Dent. 2011;4:93–100. https://doi.org/10.5005/jp-journals-10005-1089.CrossRefPubMed

36.

Silness J, Loe H. Periodontal Disease in pregnancy. Ii. Correlation between oral Hygiene and Periodontal Condtion. Acta Odontol Scand. 1964;22:121–35.CrossRefPubMed

37.

Klein H, Palmer CE. Studies on Dental Caries: VII. Sex differences in Dental Caries experience of Elementary School Children. Public Health Rep (1896–1970). 1938;53:1685–90. https://doi.org/10.2307/4582662.CrossRef

38.

Cakir Kilinc NN, Demirbuga S. The influence of different placement techniques on the clinical success of bulk-fill resin composites placed in class II cavities: a 4-year randomized controlled clinical study. Clin Oral Investig. 2022. https://doi.org/10.1007/s00784-022-04749-7. Epub ahead of print.CrossRefPubMed

39.

Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159–74. https://doi.org/10.2307/2529310.CrossRefPubMed

40.

Smail-Faugeron V, Fron-Chabouis H, Courson F, et al. Comparison of intervention effects in split-mouth and parallel-arm randomized controlled trials: a meta-epidemiological study. BMC Med Res Methodol. 2014;14:64. https://doi.org/10.1186/1471-2288-14-64.CrossRefPubMedPubMedCentral

41.

Pandis N, Walsh T, Polychronopoulou A, et al. Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. Eur J Orthod. 2013;35:783–9. https://doi.org/10.1093/ejo/cjs108.CrossRefPubMed

42.

Kubo S, Kawasaki A, Hayashi Y. Factors associated with the longevity of resin composite restorations. Dent Mater J. 2011;30:374–83.CrossRefPubMed

43.

Kilpatrick NM. Durability of restorations in primary molars. J Dent. 1993;21:67–73.CrossRefPubMed

44.

Nayyer M, Zahid S, Hassan SH, et al. Comparative abrasive wear resistance and surface analysis of dental resin-based materials. Eur J Dent. 2018;12:57–66. https://doi.org/10.4103/ejd.ejd_380_17.CrossRefPubMedPubMedCentral

45.

Abu-Bakr N, Han L, Okamoto A, et al. Color stability of compomer after immersion in various media. J Esthet Dent. 2000;12:258–63. https://doi.org/10.1111/j.1708-8240.2000.tb00232.x.CrossRefPubMed

46.

Hussain S, Roomian T, Anderson C, et al. Color Stability of three restorative materials – an in Vitro Study. J Dent Res. 2017;96(Spec Iss A):1946.

47.

Sajini SI, Mushayt AB, Almutairi TA, et al. Color Stability of Bioactive restorative materials after immersion in various media. J Int Soc Prev Commu. 2022;12:418–25. https://doi.org/10.4103/jispcd.JISPCD_40_22.CrossRef

48.

Efes B, Sengez CB, Sengun G, et al. Effects of two different mediums on different restorative materials. J Dent Res. 2016;95:0424. (Spec Iss A).

49.

Ebaya MM, Ali AI, Mahmoud SH. Evaluation of marginal adaptation and microleakage of three Glass Ionomer-based class V restorations: in Vitro Study. Eur J Dent. 2019;13:599–606. https://doi.org/10.1055/s-0039-3401435.CrossRefPubMedPubMedCentral

50.

Cannavo M, Harsono M, Finkelman M, et al. Microleakage of Dental Bulk fill, Conventional, and self-adhesive composites. J Dent Res. 2014;93:847. (Spec Iss A).

51.

Benetti AR, Michou S, Larsen L, et al. Adhesion and marginal adaptation of a claimed bioactive, restorative material. Biomater Investig Dent. 2019;6:90–8. https://doi.org/10.1080/26415275.2019.1696202.CrossRefPubMedPubMedCentral

52.

van Dijken JWV, Pallesen U, Benetti A. A randomized controlled evaluation of posterior resin restorations of an altered resin modified glass-ionomer cement with claimed bioactivity. Dent Mater. 2019;35:335–43. https://doi.org/10.1016/j.dental.2018.11.027.CrossRefPubMed

53.

Pulpdent. (2017) ACTIVA BioACTIVE a closer look at bioactive materials. https://www.pulpdent.com/wp-content/uploads/2019/09/ACTIVA-White-Paper-XF-VWP6-REV-06-2017-3.pdf. Accessed 10 September 2019.

54.

Nicholson JW. Polyacid-modified composite resins (compomers) and their use in clinical dentistry. Dent Mater. 2007;23:615–22. https://doi.org/10.1016/j.dental.2006.05.002.CrossRefPubMed

Title: 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
Authors: Reda Banon
Jeroen Vandenbulcke
Jakob Van Acker
Luc Martens
Peter De Coster
Sivaprakash Rajasekharan
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Caries
Dental Plaque Index
Caries Index
Published in: BMC Oral Health / Issue 1/2024
Electronic ISSN: 1472-6831
DOI: https://doi.org/10.1186/s12903-024-04132-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Objectives

Materials and methods

Results

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objectives

Materials and methods

Results

Conclusion

Trial registration

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