Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

Study Overview
=================
Brief Summary
-----------------
This randomized, multi-centric, controlled clinical trial will assess the effectiveness of a simplified restorative protocol used after the selective carious tissue removal in posterior teeth presenting deep carious lesions. Only a regular bulk-fill composite will be used in the simplified restorative protocol following the application of universal adhesive. A liner with resin-modified glass ionomer will be used over the pulpal floor before the composite placement in the control group. The longevity of restorative procedures and post-operative sensitivity were defined as the main and secondary outcomes.

Official Title
-----------------
Is the Use of a Glass Ionomer Liner Necessary After Selective Carious Tissue Removal?

Conditions
-----------------
Caries; Dentin, Dental Restoration Failure of Marginal Integrity

Intervention / Treatment
-----------------
* Procedure: Restoration of carious lesions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Molar presenting deep carious lesion; Exclusion Criteria: Non-vital teeth or teeth presenting pulpitis; Cavity margins in dentin; Presence of non-carious cervical lesions; The necessity of restoration involving any cusp replacement.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simplified restorative procedure<br>After selective carious tissue removal, the universal adhesive (Adper Universal; 3M ESPE, St. Paul, MN, EUA) will be applied on the cavity walls. The cavity will be restored using a single increment of Filtek One Bulk Fill (3M ESPE, St. Paul, MN, EUA). | Procedure: Restoration of carious lesions<br>* Selective carious tissue removal followed by restoration of the cavity using composite resin.<br>|
| Active Comparator: Control<br>A thin layer of resin-modified glass ionomer (Ionoseal (Voco America Inc., Briarcliff Manor, NY, EUA) will be placed on the pulpal floor of the cavity. Then, the adhesive and composite will be used following the same directions defined for the experimental condition. | Procedure: Restoration of carious lesions<br>* Selective carious tissue removal followed by restoration of the cavity using composite resin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longevity of restoration | Assessment of any failure in restorations according to the FDI World Dental Federation criteria. | Annual evaluation during 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth sensitivity | The participants will self-assess their level of tooth sensitivity of the restored teeth using a visual analogue scale of 0-10 (0 indicating absence of pain; and 10 the worst pain possible) oriented by both verbal description and Wong-Baker facial grimace scales. | 15 days after the restorative procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glass ionomer, Bulk-Fill Composite