Recruiting

Hall Technique, Modified Hall Technique, Conventional Stainless-Steel Crown

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04822233

Conditions

Dental Caries

Eligibility Criteria

Sex: All

Age: 5 - 8

Healthy Volunteers: Not accepted

Interventions

Hall Technique (HT)

Modified Hall Technique (MHT)

Conventional Technique (CT)

Study Details

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

Study ID

NCT04822233

Start date

Jun 1, 2023

Status verified date

May, 2023

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 8

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hall Technique (HT)

experimental: Modified Hall Technique (MHT)

active comparator: Conventional Technique (CT)

Interventions

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.

Primary outcome measure

  • Success as assessed by number of participants with no coronal or peri-radicular pathology [ Time Frame: 3 months post intervention ]
  • Success as assessed by number of participants with no coronal or peri-radicular pathology [ Time Frame: 6 months post intervention ]
  • Success as assessed by number of participants with no coronal or peri-radicular pathology [ Time Frame: 9 months post intervention ]
  • Success as assessed by number of participants with no coronal or peri-radicular pathology [ Time Frame: 12 months post intervention ]
  • Amount of time taken to complete the intervention [ Time Frame: from start of intervention to end of intervention (about 45 minutes to 11/2 hours) ]

Central Contacts and Locations

Central contacts

Nathanael O Salako, BDS,MSc

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

Sandra Jung

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Nathanael O Salako, BDS,MSc

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

Sandra Jung

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 19, 2023

Last verified

May, 2023

Keywords

  • molars

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2023-05-19.