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

Study Overview
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Brief Summary
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Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.

Official Title
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Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority Randomized Clinical Trial

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Procedure: Dental Restoration with Chemically activated Composite resin Alkasite
* Procedure: Dental Restoration with Bulk fill resin composite


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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
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: Bulk fill resin composite<br>Single placement of Bulk fill resin composite on atypical cavities. | Procedure: Dental Restoration with Bulk fill resin composite<br>* Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with bulk fill resin composite.<br>|

What is the study measuring?
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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 visual Clinical 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 treatment. | 
| 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 treatment. | 
| 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 days after treatment. | 
| 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 months after treatment. | 

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