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

Jouf University

Status: Completed

Conditions: Secondary Caries

Treatments: Device: Beautifil II Giomer; Device: Filtek Z350 XT Composite Resin; Device: Fuji IX GP Glass Ionomer Cement; Device: Cention N

Study type: Interventional

Funder types: Other

Identifiers

NCT07619378

1-02-45

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Conventional resin composite restorations

Active Comparator group

Description:

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.

Treatment:

Device: Cention N

Device: Fuji IX GP Glass Ionomer Cement

Device: Beautifil II Giomer

Glass Ionomer Cement (GIC)

Experimental group

Description:

Arm 2 - Glass Ionomer Cement (GIC): Participants received restorations using Fuji IX GP conventional glass ionomer cement with fluoride-releasing properties.

Treatment:

Device: Cention N

Device: Filtek Z350 XT Composite Resin

Device: Beautifil II Giomer

Giomer

Active Comparator group

Description:

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.

Treatment:

Device: Cention N

Device: Fuji IX GP Glass Ionomer Cement

Device: Filtek Z350 XT Composite Resin

Cention N

Experimental group

Description:

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.

Treatment:

Device: Fuji IX GP Glass Ionomer Cement

Device: Filtek Z350 XT Composite Resin

Device: Beautifil II Giomer