Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth

Study Overview
=================
Brief Summary
-----------------
Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.

Official Title
-----------------
Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth - Randomized Clinical Trial

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Procedure: Dental Restoration with Chemically activated Composite resin Alkasite
* Procedure: Dental Restoration with Resin-Modified Glass ionomer Cement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Children will be included who have at least one posterior tooth with atypical caries lesion. Exclusion Criteria: Patients with special needs Patients general health conditions that may affect the oral cavity Patients non-cooperating in relation to the examination Patients with orthodontic apparatus The parents/guardians or children not to consent to their participation in the study. Teeth with pulp exposure Teeth with spontaneous pain Teeth with mobility Teeth with presence of swelling or fistula close to the tooth Teeth with furcation or cervical injury Teeth with restorations, sealants or enamel formation defects will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 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
Interventional Model Description: Compare the survival of restorations performed with chemically activated composite resin alkasite and resin- modified glass ionomer cement.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemically activated Composite resin Alkasite<br>Single placement of composite resin on atypical cavities. | Procedure: Dental Restoration with Chemically activated Composite resin Alkasite<br>* Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.<br>|
| Active Comparator: Resin-Modified Glass ionomer Cement<br>Single placement of Resin-Modified Glass ionomer Cement on atypical cavities. | Procedure: Dental Restoration with Resin-Modified Glass ionomer Cement<br>* Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of restoration | To evaluate the survival of restoration by clinical examination with FDI index. | 12 months after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries lesion progression | For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration. | 12 months after treatment. | 
| Secondary caries lesion or on the surface adjacent to the restored tooth | Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visualClinical Examination | 12 months after treatment. | 
| Perception of children and parents/guardians | To evaluate the satisfaction of the children in relation to the treatment performed. The questionnaire will be used  Child's and parent's questionnaire about teeth appearance. | 6 months after treatment. | 
| Operator perception | It will be employed a questionnaire after the completion of the treatment performed. It will also be added a question about the behavior of children during the procedure, which will be categorized as - great behavior, regular or bad. | 6 months after the restoration. | 
| Parents/Guardians Satisfaction | The parents/guardians will be questioned about the satisfaction regarding the treatment performed in the child. The answer will be scored by a likert scale. | 6 months after restoration. | 
| Child discomfort | The child will also be questioned as to the discomfort in relation to the treatment performed. For this will be used the scale of faces of Wong-Baker. | Immediately after the treatment. | 
| Post Operative sensitivity of the child | The child will also be questioned about the sensitivity of the restorative procedure. For this, the Wong-Baker face scale will be used. | 7 ° day after the restorative procedure. | 
| Oral health-related quality of life | The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents. | 6 month of restorative treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental caries, Deciduous teeth, Permanent dental restoration