Effect of Bioactive Restorative Materials on Secondary Caries Prevention

N/ACompletedNCT07619378

Jouf University120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Secondary Caries

Interventions

Fuji IX GP Glass Ionomer CementDEVICE

Fuji IX GP Glass Ionomer Cement

Beautifil II GiomerDEVICE

Beautifil II Giomer

Cention NDEVICE

Cention N

Filtek Z350 XT Composite Resin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

College of Dentistry, Jouf University

Sakakah, Aljouf, Saudi Arabia

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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