Secondary Caries
Conditions
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.
Interventions
DEVICEFuji IX GP Glass Ionomer Cement
Fuji IX GP Glass Ionomer Cement
DEVICEBeautifil II Giomer
Beautifil II Giomer
DEVICECention N
Cention N
DEVICEFiltek Z350 XT Composite Resin
Filtek Z350 XT Composite Resin
Sponsors
Jouf University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measure | 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. |
Countries
Saudi Arabia
Outcome results
None listed