NCT06544486

Contemporary Restorative Materials in Primary Molars

Clinical Evaluation of Contemporary Ion Releasing Restorative Materials in Primary Molars Subjected to Selective Caries Removal: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Akdeniz University · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are: * Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations? * Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria. Participants will: \- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.

Conditions

• Dental Caries

Interventions

Type	Name	Description
PROCEDURE	Caries Removal	The cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction.
PROCEDURE	Filling	Sectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-06-21
• Completion: 2024-07-19
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: Turkey (Türkiye)