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NCT Number: NCT07619378

Effect of Bioactive Restorative Materials on Secondary Caries Prevention

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.

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Key information

Conditions

Secondary Caries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, Jouf University

Sakakah, Aljouf, 72388, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fuji IX GP Glass Ionomer Cement

Device

Fuji IX GP Glass Ionomer Cement

Beautifil II Giomer

Device

Beautifil II Giomer

Cention N

Device

Cention N

Filtek Z350 XT Composite Resin

Device

Filtek Z350 XT Composite Resin

Primary outcomes

  1. Primary outcome measure

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Jouf University

Other

Registry information

Official study title

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

Acronym: BARM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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