Caries
Conditions
Brief summary
Despite preventive treatments and the promotion of oral health, dental caries is one of the most prevalent chronic diseases in the population and treatment of caries lesions in deciduous teeth is a fundamental procedure aimed at increasing the resistance of the remaining tooth structure to preserve the permanent dentition. The present study aims to make a clinical evaluation of the Hall Technique compared to direct restorations with universal adhesives and bulk fill resins in large destruction of deciduous teeth. 90 children between 5 and 10 years old, healthy, of both sexes, without distinction of race, enrolled in the clinics of Universidade Metropolitana de Santos-UNIMES will be selected. The in-office treatments will be carried out by a trained researcher, according to the manufacturer's instructions for each material and scientific evidence on the respective topic. Participants will be divided into 03 groups according to the proposed treatments. Group 1 - Universal adhesive restorative procedure + condensable bulk fill resin; Group 2 - Hall Technique with Shofu steel crowns and Group 3 - Steel crown with conventional technique. The evaluated outcomes will be: effectiveness of the technique and longevity of the restorations.
Interventions
PROCEDURERestoration with Resin
Prophylaxis with prophylactic paste and rubber cup. Relative isolation (lip retractor, cotton roll and saliva sucker). Selective removal of carious tissue with dentin spoons at the dentin-enamel junction. Cleaning the cavity with water. Application of the Universal Adhesive System (Shofu). Excess removal. Application of a new layer of adhesive system. Light rubbing and excess removal. Photoactivation - 20s. Insert Bulk Fill Resin (Shofu) in 4mm increments. Photoactivation for 20. Preservation. Clinical and radiographic control at 1, 3, 6 and 12 months.
PROCEDUREHall Technique
Prophylaxis with prophylactic paste and rubber cup. Relative isolation (lip retractor, cotton roll and saliva sucker). Clinical evaluation through inspection of the texture of the remaining dentin with a rounded exploratory probe. Cleaning the cavity with water. Take drying. Proof of the steel crown. Relative isolation. Filling the inner part of the crown with bioactive resin cement or glass ionomer cement for cementation. Clinical and radiographic control at 1, 3, 6 and 12 months.
PROCEDUREConventional Steel Crown
* Prophylaxis; * Relative isolation; * The preparation of the tooth will be performed conventionally with reduction of the occlusal, mesial and distal surface of 1 to 1.5 mm and selective removal of the decayed tissue; * Cleaning the cavity with water; * Slight drying; * Trial of steel crown; * Relative isolation; * Filling the inner part of the crown with bioactive resin cement or glass ionomer cement for cementation. * Clinical and radiographic control at 1, 3, 6 and 12 months.
Sponsors
Universidade Metropolitana de Santos
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical and radiographic evaluations of the complete removal of the carious lesion will be performed by two calibrated examiners blinded to the allocation of teeth to the different groups. Also, calibrated examiners, who will not be performing the restorations and therefore will be blind to the groups, will perform the assessment.
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy child, without systemic changes; 2. Good behavior; 3. Clinically, present at least two deciduous molars with caries in dentin involving more than three surfaces, with vision and direct access, without signs and symptoms of pulp involvement.
Exclusion criteria
1. Children with any serious systemic disorder; 2. Lack of cooperation. 3. Clinically present at least one deciduous molar with carious lesion in the dentin involving signs and symptoms of pulpal involvement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Longevity Of Restorations | Three, 6 and 12 months after treatment. | Steel restorations and crowns will be classified according to the criteria in the following scores: FDI criterion (clinically very good, clinically good, clinically sufficient/satisfactory, clinically unsatisfactory, clinically poor). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the biofilm index | Baseline, 3, 6, and 12 months after treatment. | The presence of biofilm will be evaluated through the Simplified Oral Hygiene Index (OHI-S). |
| Changes in Salivary PH | Baseline, 6, and 12 months after treatment. | Participants will be asked to spit into a collection pot, in which the pH will be measured with measuring stripes. |
| Changes in The Presence of Caries Lesions | Baseline, 6, and 12 months after treatment. | A clinical evaluation in the search of carious lesions will be performed. |
| Technique Perfomance Time Duration | During the procedure. | To take the time, a previously calibrated digital stopwatch will be used. |
Outcome results
None listed