36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions

Hacettepe University

Status: Unknown

Conditions: Root Caries

Treatments: Device: Spectrum TPH3; Device: Riva LC

Study type: Interventional

Funder types: Other

Identifiers

NCT03722758

2016/03-23 (KA-16003)

Details and patient eligibility

About

This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.

Full description

The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions.

Thirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05).

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Root caries lesions (at least 1mm depth)

Exclusion criteria

• Complex medical history
• Poor dental hygiene/infrequent practise of oral hygiene habits
• Severe or chronic periodontitis
• Extreme carious activity
• Heavy bruxism
• Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm)
• Previously restored and abutment teeth for bridge or removable dental prostheses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Spectrum TPH3, tooth restoration

Active Comparator group

Description:

Restoration with micro hybrid resin composite

Treatment:

Device: Riva LC

Device: Spectrum TPH3

Riva LC, restorative material

Active Comparator group

Description:

Restoration with resin-modified glass ionomer cement

Treatment:

Device: Riva LC

Device: Spectrum TPH3