Effect of Bioactive Restorative Materials on Secondary Caries Prevention (BARM)

Effect of Bioactive Restorative Materials on Secondary Caries Prevention: A 24-month Randomized Clinical Trial

This manuscript presents a 24-month randomised clinical trial evaluating the effectiveness of bioactive restorative materials in preventing secondary caries compared with conventional composite restorations. Four restorative materials were tested in 120 class I and II cavities among high-caries-risk adults: conventional composite (Filtek Z350 XT), glass ionomer cement (Fuji IX GP), giomer (Beautifil II), and Cention N.

Study Overview

• Status: Completed
• Conditions: Secondary Caries
• Intervention / Treatment: Device: Fuji IX GP Glass Ionomer Cement; Device: Beautifil II Giomer; Device: Cention N; Device: Filtek Z350 XT Composite Resin

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Aljouf
    • Sakakah, Aljouf, Saudi Arabia, 72388
      • College of Dentistry, Jouf University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18-55 years
• Presence of at least one primary Class I or Class II cavity in a permanent posterior tooth
• High caries risk with DMFT score ≥ 4 according to the Cariogram assessment
• Presence of at least 20 functional teeth
• Good general health
• Ability and willingness to attend follow-up and recall visits

Exclusion Criteria:

• Pregnant women
• Patients undergoing current orthodontic treatment
• Presence of severe periodontitis
• Xerostomia
• Known allergy to any restorative material component used in the study
• Bruxism or parafunctional habits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional resin composite restorations; Arm 1 - Composite (Control): Participants received restorations using Filtek Z350 XT nano-filled resin composite placed according to the manufacturer's instructions following minimally invasive cavity preparation.	Device: Fuji IX GP Glass Ionomer Cement; Fuji IX GP Glass Ionomer Cement; Device: Beautifil II Giomer; Beautifil II Giomer; Device: Cention N; Cention N
Experimental: Glass Ionomer Cement (GIC); Arm 2 - Glass Ionomer Cement (GIC): Participants received restorations using Fuji IX GP conventional glass ionomer cement with fluoride-releasing properties.	Device: Beautifil II Giomer; Beautifil II Giomer; Device: Cention N; Cention N; Device: Filtek Z350 XT Composite Resin; Filtek Z350 XT Composite Resin
Active Comparator: Giomer; Arm 3 - Giomer: Participants received restorations using Beautifil II giomer restorative material containing surface pre-reacted glass ionomer (S-PRG) fillers capable of releasing and recharging bioactive ions.	Device: Fuji IX GP Glass Ionomer Cement; Fuji IX GP Glass Ionomer Cement; Device: Cention N; Cention N; Device: Filtek Z350 XT Composite Resin; Filtek Z350 XT Composite Resin
Experimental: Cention N; Cention N: Participants received restorations using Cention N alkasite restorative material containing alkaline glass fillers designed to release calcium, hydroxide, and fluoride ions under acidic conditions.	Device: Fuji IX GP Glass Ionomer Cement; Fuji IX GP Glass Ionomer Cement; Device: Beautifil II Giomer; Beautifil II Giomer; Device: Filtek Z350 XT Composite Resin; Filtek Z350 XT Composite Resin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome measure	Number of Restorations Developing Secondary Caries. Secondary caries will be assessed using the International Caries Detection and Assessment System (ICDAS-II), with any score ≥3 at the cavosurface margin considered indicative of secondary caries. Evaluations will be performed at baseline, 6, 12, and 24 months.	2 years

Collaborators and Investigators

• Sponsor: Jouf University

Publications and helpful links

General Publications

• 1.Kassebaum NJ, Smith AGC, Bernabé E, Fleming TD, Reynolds AE, Vos T, et al. Global, regional, and national prevalence, incidence, and disability-adjusted life years for oral conditions for 195 countries, 1990-2015. J Dent Res. 2017;96(4):380-387. doi:10.1177/0022034517693566. 2.Peres MA, Macpherson LMD, Weyant RJ, Daly B, Venturelli R, Mathur MR, et al. Oral diseases: a global public health challenge. Lancet. 2019;394(10194):249-260. doi:10.1016/S0140-6736(19)31146-8. 3.Demarco FF, Corrêa MB, Cenci MS, Moraes RR, Opdam NJM. Longevity of posterior composite restorations: not only a matter of materials. Dent Mater. 2012;28(1):87-101. doi:10.1016/j.dental.2011.09.003. 4.Opdam NJM, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, et al. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014;93(10):943-949. doi:10.1177/0022034514544217. 5.Mjör IA, Toffenetti F. Secondary caries: a literature review with case reports. Quintessence Int. 2000;31(3):165-179. 6.Eltahlah D, Lynch CD, Chadwick BL, Blum IR, Wilson NHF. An update on the reasons for placement and replacement of direct restorations. J Dent. 2018;72:1-7. doi:10.1016/j.jdent.2018.03.001. 7.Kopperud SE, Tveit AB, Gaarden T, Sandvik L, Espelid I. Longevity of posterior dental restorations and reasons for failure. Eur J Oral Sci. 2012;120(6):539-548. doi:10.1111/eos.12004. 8.Nedeljkovic I, Teughels W, De Munck J, Van Meerbeek B, Van Landuyt KL. Is secondary caries with composites a material-based problem? Dent Mater. 2015;31(11):e247-e277. doi:10.1016/j.dental.2015.09.001. 9.Kidd EAM. Diagnosis of secondary caries. J Dent Educ. 2001;65(10):997-1000. doi:10.1002/j.0022-0337.2001.65.10.tb03459.x. 10.Ferracane JL. Resin composite-state of the art. Dent Mater. 2011;27(1):29-38. doi:10.1016/j.dental.2010.10.020. 11.Schwendicke F, Tu YK, Hsu LY, Göstemeyer G. Antibacterial effects of cavity lining materials in caries-affected dentine: a systematic review. Cari

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1-02-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data may be made available by the corresponding author upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No