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

Root Caries Clinical Trial

Official title:

Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03722758
• Other study ID #: 2016/03-23 (KA-16003)
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2016
• Est. completion date: November 15, 2019

Study information

• Verified date: July 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: November 15, 2019
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Root Caries

Intervention

Device:
• Spectrum TPH3
tooth restoration with two different restorative materials
• Riva LC
tooth restoration with two different restorative materials

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal adaptation 0 for at least 90% restorations (marginal adaption score)	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.	24 months