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.

NCT04822233 | Unknown FDA Device

• 1 other identifier: HSC-DB-20-1247
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

molars

Outcome Measures

Primary Outcomes (5)

• Success as assessed by number of participants with no coronal or peri-radicular pathology

  3 months post intervention

• Success as assessed by number of participants with no coronal or peri-radicular pathology

  6 months post intervention

• Success as assessed by number of participants with no coronal or peri-radicular pathology

  9 months post intervention

• Success as assessed by number of participants with no coronal or peri-radicular pathology

  12 months post intervention

• Amount of time taken to complete the intervention

  from start of intervention to end of intervention (about 45 minutes to 11/2 hours)

Secondary Outcomes (20)

• Number of participants with occlusal contact of the molars as assessed by the strip test

  3 months post intervention

• Number of participants occlusal contact of the molars as assessed by the strip test

  6 months post intervention

• Number of participants occlusal contact of the molars as assessed by the strip test

  9 months post intervention

• Number of participants occlusal contact of the molars as assessed by the strip test

  12 months post intervention

• Molar height in occlusion

  3 months post intervention

Study Arms (3)

Hall Technique (HT)

EXPERIMENTAL

Device: Hall Technique (HT)

Modified Hall Technique (MHT)

EXPERIMENTAL

Device: Modified Hall Technique (MHT)

Conventional Technique (CT)

ACTIVE COMPARATOR

Device: Conventional Technique (CT)

Interventions

Hall Technique (HT) 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.

Hall Technique (HT)

Modified Hall Technique (MHT) 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.

Modified Hall Technique (MHT)

Conventional Technique (CT) 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.

Conventional Technique (CT)

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nathanael O Salako, BDS,MSc

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathanael O Salako, BDS,MSc

CONTACT

(713) 486-4141; Nathanael.O.Salako@uth.tmc.edu

Sandra Jung

CONTACT

713-486-4026; Sandra.Jung@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 30, 2021
• Study Start: June 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)