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.

Dental Caries Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822233
• Other study ID #: HSC-DB-20-1247
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Nathanael O Salako, BDS,MSc
• Phone: (713) 486-4141
• Email: Nathanael.O.Salako[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success as assessed by number of participants with no coronal or peri-radicular pathology		3 months post intervention
Primary	Success as assessed by number of participants with no coronal or peri-radicular pathology		6 months post intervention
Primary	Success as assessed by number of participants with no coronal or peri-radicular pathology		9 months post intervention
Primary	Success as assessed by number of participants with no coronal or peri-radicular pathology		12 months post intervention
Primary	Amount of time taken to complete the intervention		from start of intervention to end of intervention (about 45 minutes to 11/2 hours)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Molar height in occlusion		3 months post intervention
Secondary	Molar height in occlusion		6 months post intervention
Secondary	Molar height in occlusion		9 months post intervention
Secondary	Molar height in occlusion		12 months post intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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