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

NCT05301439 | Unknown Phase 1

• 1 other identifier: HallTechnique
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in the biofilm index

  Baseline, 3, 6, and 12 months after treatment.

• Changes in Salivary PH

  Baseline, 6, and 12 months after treatment.

• Changes in The Presence of Caries Lesions

  Baseline, 6, and 12 months after treatment.

• Technique Perfomance Time Duration

  During the procedure.

Study Arms (3)

Restoration Group

EXPERIMENTAL

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

Hall Technique Group

EXPERIMENTAL

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

Procedure: Hall Technique

Steel Crown with Conventional Technique Group

EXPERIMENTAL

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

Procedure: Conventional Steel Crown

Interventions

Restoration with Resin 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.

Restoration Group

Hall Technique 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.

Hall Technique Group

Conventional Steel Crown 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.

Steel Crown with Conventional Technique Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy child, without systemic changes;
• Good behavior;
• 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.

You may not qualify if:

• Children with any serious systemic disorder;
• Lack of cooperation.
• Clinically present at least one deciduous molar with carious lesion in the dentin involving signs and symptoms of pulpal involvement.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Universidade Metropolitana de Santos: collaborator

MeSH Terms

Interventions

Resins, Plant

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 29, 2022
• Study Start: June 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: June 20, 2024
• Last Updated: March 21, 2023

Record last verified: 2023-03