Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions

Controlled Clinical Trial Of The Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions. Follow Up Of 12 Months.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries
• Intervention / Treatment: Procedure: Restoration with Resin; Procedure: Hall Technique; Procedure: Conventional Steel Crown

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restoration Group; 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; 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.
Experimental: Hall Technique Group; Participants in this group will receive the Hall Technique with steel crowns for the restoration of the cavited teeth.	Procedure: Hall 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.
Experimental: Steel Crown with Conventional Technique Group; Participants in this group will receive steel crowns with conventional technique for the restoration of the cavited teeth.	Procedure: Conventional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Three, 6 and 12 months after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the biofilm index	The presence of biofilm will be evaluated through the Simplified Oral Hygiene Index (OHI-S).	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.	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.	Baseline, 6, and 12 months after treatment.
Technique Perfomance Time Duration	To take the time, a previously calibrated digital stopwatch will be used.	During the procedure.

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: Universidade Metropolitana de Santos

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2023
• Primary Completion (Anticipated): December 20, 2023
• Study Completion (Anticipated): June 20, 2024

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HallTechnique

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No