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Clinical Trials/NCT07619378
NCT07619378CompletedNot Applicable

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

Jouf University1 site in 1 country120 target enrollmentStarted: May 1, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts 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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Meshal Alonazi

Associate Professor

Jouf University

Study Sites (1)

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