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

Phase 1

Not yet recruiting

• Conditions: Caries
• Interventions: Procedure: Restoration with Resin; Procedure: Hall Technique; Procedure: Conventional Steel Crown

• Registration Number: NCT05301439
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-03-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-21
• Study Start: 2023-06-20
• Primary Completion: 2023-12-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restoration Group	Restoration with Resin	Participants in this group will receive the universal adhesive restorative procedure combined with condensable bulk fill resin, for the restoration of the cavited teeth.
Hall Technique Group	Hall Technique	Participants in this group will receive the Hall Technique with steel crowns for the restoration of the cavited teeth.
Steel Crown with Conventional Technique Group	Conventional Steel Crown	Participants in this group will receive steel crowns with conventional technique for the restoration of the cavited teeth.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Technique Perfomance Time Duration	During the procedure.	To take the time, a previously calibrated digital stopwatch will be used.
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 The Presence of Caries Lesions	Baseline, 6, and 12 months after treatment.	A clinical evaluation in the search of carious lesions will be performed.