A Phase 1/2 interventional study of Restoration with Resin and Hall Technique in Caries, sponsored by University of Nove de Julho. Status unknown. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by University of Nove de Julho · Phase 1/2, Interventional, and Treatment
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.
University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
Participants in this group will receive the universal adhesive restorative procedure combined with condensable bulk fill resin, for the restoration of the cavited teeth.
Procedure: Restoration with Resin
Participants in this group will receive the Hall Technique with steel crowns for the restoration of the cavited teeth.
Procedure: Hall Technique
Participants in this group will receive steel crowns with conventional technique for the restoration of the cavited teeth.
Procedure: Conventional Steel Crown
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.
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.
* 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.
Changes in the Longevity Of Restorations
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).
Time frame: Three, 6 and 12 months after treatment.
Changes in the biofilm index
The presence of biofilm will be evaluated through the Simplified Oral Hygiene Index (OHI-S).
Time frame: Baseline, 3, 6, and 12 months after treatment.
Changes in Salivary PH
Participants will be asked to spit into a collection pot, in which the pH will be measured with measuring stripes.
Time frame: Baseline, 6, and 12 months after treatment.
Changes in The Presence of Caries Lesions
A clinical evaluation in the search of carious lesions will be performed.
Time frame: Baseline, 6, and 12 months after treatment.
Technique Perfomance Time Duration
To take the time, a previously calibrated digital stopwatch will be used.
Time frame: During the procedure.
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Nove de Julho