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

Sponsor
University of Nove de Julho (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05301439
Collaborator
Universidade Metropolitana de Santos (Other)
60
Enrollment
2
Arms
10
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This controlled clinical trial aims to make a clinical evaluation of Hall Technique compared to direct restorations with universal adhesives and bulk fill resins in major destruction of primary teeth. Sixty healthy children between 6 and 8 years old, of both sexes, without distinction of race, will be selected, enrolled in the clinics of the Metropolitan University of Santos and FAOA/APCD Central in the city of São Paulo. The selected teeth will be randomly divided by drawing lots in brown envelopes. According to the drawing by the number of the clinical examination protocol, the subjects will be divided into four groups: Group 1 - Universal adhesive restorative procedure + condensable bulk fill resin (Universal Adhesive + bioactive and condensable bulk fill - Shofu); Group 2 - - Hall Technique with Shofu steel crowns. To evaluate the effectiveness of the Hall technique and the resins, the oral health condition of the treated children will be evaluated after 6 and 12 months after the treatment and compared with the oral health condition found before the treatment.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Restoration with Resin
  • Procedure: Hall Technique
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Controlled Clinical Trial Of The Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions. Follow Up Of 12 Months.
Anticipated Study Start Date :
Aug 20, 2022
Anticipated Primary Completion Date :
Mar 20, 2023
Anticipated Study Completion Date :
Jun 20, 2023

Arms and Interventions

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 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 3, 6 and 12 months.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. 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.

  3. 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.

  4. Technique Perfomance Time Duration [During the procedure.]

    To take the time, a previously calibrated digital stopwatch will be used.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Nove de Julho
  • Universidade Metropolitana de Santos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT05301439
Other Study ID Numbers:
  • HallTechnique
First Posted:
Mar 29, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 29, 2022