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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05301439
• Other study ID #: HallTechnique
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 20, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: March 2023
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Universidade Metropolitana de Santos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	Technique Perfomance Time Duration	To take the time, a previously calibrated digital stopwatch will be used.	During the procedure.