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

Not Applicable

• Conditions: Root Caries
• Interventions: Device: Spectrum TPH3; Device: Riva LC

• Registration Number: NCT03722758
• Lead Sponsor: Hacettepe University

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2016-07-15
• Primary Completion: 2018-07-15
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15
• Study Completion: 2019-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Spectrum TPH3, tooth restoration	Spectrum TPH3	Restoration with micro hybrid resin composite
Riva LC, restorative material	Spectrum TPH3	Restoration with resin-modified glass ionomer cement
Riva LC, restorative material	Riva LC	Restoration with resin-modified glass ionomer cement
Spectrum TPH3, tooth restoration	Riva LC	Restoration with micro hybrid resin composite

Primary Outcome Measures

Name	Time	Method
Marginal adaptation 0 for at least 90% restorations (marginal adaption score)	24 months	The primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost).; Clinical evaluation is performed to examine if the restorations are in place or fallen.