A Comparative Study of Hall Technique, Modified Hall Technique and Conventional Stainless-Steel Crown Restorations in the Treatment of Primary Molars With Proximal Caries Lesions.
NCT ID: NCT04822233
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2023-06-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hall Technique (HT)
Hall Technique (HT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swap and dispensed in a transport medium for microbial analyses.The preformed metal crown (PMC) will placed without local anesthetic and without crimping or trimming. When the contact points are tight, an orthodontic elastic separator will be placed for 2 hours prior to PMC placement. The PMCs will be cemented with glass ionomer Ketac cem.
Modified Hall Technique (MHT)
Modified Hall Technique (MHT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses.This group will in addition to all the procedures for the Hall will have the Caries lesions treated with 30% Silver Diamine Fluoride (SDF) before cementation of the stainless-steel crowns.
Conventional Technique (CT)
Conventional Technique (CT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses. Conventional occlusal, proximal slicing and when necessary buccal and lingual surfaces will be carried out under local anesthesia and dental dam isolation local anesthesia.The PMC will be trimmed and crimped at the gingival margin to improve the fit, and cemented with Ketac cem.
Interventions
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Hall Technique (HT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swap and dispensed in a transport medium for microbial analyses.The preformed metal crown (PMC) will placed without local anesthetic and without crimping or trimming. When the contact points are tight, an orthodontic elastic separator will be placed for 2 hours prior to PMC placement. The PMCs will be cemented with glass ionomer Ketac cem.
Modified Hall Technique (MHT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses.This group will in addition to all the procedures for the Hall will have the Caries lesions treated with 30% Silver Diamine Fluoride (SDF) before cementation of the stainless-steel crowns.
Conventional Technique (CT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses. Conventional occlusal, proximal slicing and when necessary buccal and lingual surfaces will be carried out under local anesthesia and dental dam isolation local anesthesia.The PMC will be trimmed and crimped at the gingival margin to improve the fit, and cemented with Ketac cem.
Eligibility Criteria
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Inclusion Criteria
* Children who exhibit cooperative behavior at initial bitewing radiograph procedure
* Children with symptom-free or reversible pulpitis restorable first and second primary molars in both arches
* Teeth with D1 lesions will be included
* No periapical or furcation pathologies on bite wing radiographs
Exclusion Criteria
* Children with uncooperative behavior during bitewing radiograph process
* Primary molars with irreversible pulpitis
* Teeth with furcation or peri radicular pathologies
5 Years
8 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Nat Salako BDS(Hons)
Professor
Principal Investigators
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Nathanael O Salako, BDS,MSc
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-DB-20-1247
Identifier Type: -
Identifier Source: org_study_id
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