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

Study Overview
=================
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).

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

Conditions
-----------------
Root Caries

Intervention / Treatment
-----------------
* Device: Spectrum TPH3
* Device: Riva LC


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spectrum TPH3, tooth restoration<br>Restoration with micro hybrid resin composite | Device: Spectrum TPH3<br>* tooth restoration with two different restorative materials<br>* Other names: resin composite;Device: Riva LC<br>* tooth restoration with two different restorative materials<br>* Other names: RMGİC;|
| Active Comparator: Riva LC, restorative material<br>Restoration with resin-modified glass ionomer cement | Device: Spectrum TPH3<br>* tooth restoration with two different restorative materials<br>* Other names: resin composite;Device: Riva LC<br>* tooth restoration with two different restorative materials<br>* Other names: RMGİC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
micro hybrid resin composite, resin-modified glass ionomer, split-mouth randomized clinical trial