Effect of Bioactive Restorative Materials on Secondary Caries Prevention

NCT07619378 | Completed DMC

• 1 other identifier: 1-02-45
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Secondary Caries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Conventional resin composite restorations

ACTIVE COMPARATOR

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; Device: Beautifil II Giomer; Device: Cention N

Glass Ionomer Cement (GIC)

EXPERIMENTAL

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; Device: Cention N; Device: Filtek Z350 XT Composite Resin

Giomer

ACTIVE COMPARATOR

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; Device: Cention N; Device: Filtek Z350 XT Composite Resin

Cention N

EXPERIMENTAL

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; Device: Beautifil II Giomer; Device: Filtek Z350 XT Composite Resin

Interventions

Fuji IX GP Glass Ionomer Cement DEVICE

Fuji IX GP Glass Ionomer Cement

Cention N; Conventional resin composite restorations; Giomer

Beautifil II Giomer DEVICE

Beautifil II Giomer

Cention N; Conventional resin composite restorations; Glass Ionomer Cement (GIC)

Cention N DEVICE

Cention N

Conventional resin composite restorations; Giomer; Glass Ionomer Cement (GIC)

Filtek Z350 XT Composite Resin DEVICE

Filtek Z350 XT Composite Resin

Cention N; Giomer; Glass Ionomer Cement (GIC)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

College of Dentistry, Jouf University

Sakakah, Aljouf, 72388, Saudi Arabia

Location

Related Publications (1)

• 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

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 2, 2026
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)