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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-12-01

Brief Summary

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The purpose of this study is to compare the effectiveness of the Hall technique and modified Hall technique to the conventional Stainless-Steel Crown restoration in the treatment of primary molars with dentinal caries with or without proximal ridge intact.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hall Technique (HT)

Group Type EXPERIMENTAL

Hall Technique (HT)

Intervention Type DEVICE

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)

Group Type EXPERIMENTAL

Modified Hall Technique (MHT)

Intervention Type DEVICE

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)

Group Type ACTIVE_COMPARATOR

Conventional Technique (CT)

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Medically fit children
* 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

* Medically compromised children
* Children with uncooperative behavior during bitewing radiograph process
* Primary molars with irreversible pulpitis
* Teeth with furcation or peri radicular pathologies
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Nat Salako BDS(Hons)

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nathanael O Salako, BDS,MSc

Role: CONTACT

(713) 486-4141

Sandra Jung

Role: CONTACT

713-486-4026

Facility Contacts

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Nathanael O Salako, BDS,MSc

Role: primary

713-486-4141

Sandra Jung

Role: backup

713-486-4026

Other Identifiers

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HSC-DB-20-1247

Identifier Type: -

Identifier Source: org_study_id

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