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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Device: Hall Technique (HT); Device: Modified Hall Technique (MHT); Device: Conventional Technique (CT)

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathanael O Salako, BDS,MSc; Phone Number: (713) 486-4141; Email: Nathanael.O.Salako@uth.tmc.edu
• Study Contact Backup: Name: Sandra Jung; Phone Number: 713-486-4026; Email: Sandra.Jung@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Nathanael O Salako, BDS,MSc; Phone Number: 713-486-4141; Email: Nathanael.O.Salako@uth.tmc.edu
      • Contact: Sandra Jung; Phone Number: 713-486-4026; Email: Sandra.Jung@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with occlusal contact of the molars as assessed by the strip test	Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.	3 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test	Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.	6 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test	Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.	9 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test	Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.	12 months post intervention
Molar height in occlusion		3 months post intervention
Molar height in occlusion		6 months post intervention
Molar height in occlusion		9 months post intervention
Molar height in occlusion		12 months post intervention
Anterior occlusal contact	Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.	3 months post intervention
Anterior occlusal contact	Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.	6 months post intervention
Anterior occlusal contact	Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.	9 months post intervention
Anterior occlusal contact	Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.	12 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index	In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned	3 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index	In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned	6 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index	In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned	9 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index	In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned	12 months post intervention
Gingival health of the treated tooth as assessed by gingival status score	Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).	3 months post intervention
Gingival health of the treated tooth as assessed by gingival status score	Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).	6 months post intervention
Gingival health of the treated tooth as assessed by gingival status score	Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).	9 months post intervention
Gingival health of the treated tooth as assessed by gingival status score	Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).	12 months post intervention

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Nathanael O Salako, BDS,MSc, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: molars
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: HSC-DB-20-1247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No