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

NCT ID: NCT05301439

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-06-20

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.

Conditions

Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Restoration with Resin

Intervention Type: PROCEDURE

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.

Hall Technique Group

Participants in this group will receive the Hall Technique with steel crowns for the restoration of the cavited teeth.

Group Type: EXPERIMENTAL

Hall Technique

Intervention Type: PROCEDURE

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.

Steel Crown with Conventional Technique Group

Participants in this group will receive steel crowns with conventional technique for the restoration of the cavited teeth.

Group Type: EXPERIMENTAL

Conventional Steel Crown

Intervention Type: PROCEDURE

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Metropolitana de Santos

OTHER

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HallTechnique

Identifier Type: -

Identifier Source: org_study_id