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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 5 Years and 8 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Hall Technique (HT)
  • Device: 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.
Experimental
Modified Hall Technique (MHT)
  • 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.
Active Comparator
Conventional Technique (CT)
  • 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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Nathanael O Salako, BDS,MSc
713-486-4141
Nathanael.O.Salako@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.