Back to resultsA Comparative Study of Hall Technique, Modified Hall Technique and Conventional Stainless-Steel Crown Restorations in the Treatment of Primary Molars With Proximal Caries Lesions.
Primary Purpose
Dental Caries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hall Technique (HT)
Modified Hall Technique (MHT)
Conventional Technique (CT)
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring molars
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Hall Technique (HT)
Modified Hall Technique (MHT)
Conventional Technique (CT)
Arm Description
Outcomes
Primary Outcome Measures
Success as assessed by number of participants with no coronal or peri-radicular pathology
Success as assessed by number of participants with no coronal or peri-radicular pathology
Success as assessed by number of participants with no coronal or peri-radicular pathology
Success as assessed by number of participants with no coronal or peri-radicular pathology
Amount of time taken to complete the intervention
Secondary Outcome Measures
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.
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.
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.
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.
Molar height in occlusion
Molar height in occlusion
Molar height in occlusion
Molar height in occlusion
Anterior occlusal contact
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Anterior occlusal contact
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Anterior occlusal contact
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Anterior occlusal contact
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
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
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
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
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
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).
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).
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).
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).
Full Information
NCT ID
NCT04822233
First Posted
March 23, 2021
Last Updated
May 18, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04822233
Brief 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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hall Technique (HT)
Arm Type
Experimental
Arm Title
Modified Hall Technique (MHT)
Arm Type
Experimental
Arm Title
Conventional Technique (CT)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hall Technique (HT)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Modified Hall Technique (MHT)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional Technique (CT)
Intervention Description
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 Information:
Title
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame
3 months post intervention
Title
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame
6 months post intervention
Title
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame
9 months post intervention
Title
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame
12 months post intervention
Title
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)
Secondary Outcome Measure Information:
Title
Number of participants with occlusal contact of the molars as assessed by the strip test
Description
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.
Time Frame
3 months post intervention
Title
Number of participants occlusal contact of the molars as assessed by the strip test
Description
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.
Time Frame
6 months post intervention
Title
Number of participants occlusal contact of the molars as assessed by the strip test
Description
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.
Time Frame
9 months post intervention
Title
Number of participants occlusal contact of the molars as assessed by the strip test
Description
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.
Time Frame
12 months post intervention
Title
Molar height in occlusion
Time Frame
3 months post intervention
Title
Molar height in occlusion
Time Frame
6 months post intervention
Title
Molar height in occlusion
Time Frame
9 months post intervention
Title
Molar height in occlusion
Time Frame
12 months post intervention
Title
Anterior occlusal contact
Description
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Time Frame
3 months post intervention
Title
Anterior occlusal contact
Description
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Time Frame
6 months post intervention
Title
Anterior occlusal contact
Description
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Time Frame
9 months post intervention
Title
Anterior occlusal contact
Description
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Time Frame
12 months post intervention
Title
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Description
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
Time Frame
3 months post intervention
Title
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Description
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
Time Frame
6 months post intervention
Title
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Description
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
Time Frame
9 months post intervention
Title
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Description
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
Time Frame
12 months post intervention
Title
Gingival health of the treated tooth as assessed by gingival status score
Description
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).
Time Frame
3 months post intervention
Title
Gingival health of the treated tooth as assessed by gingival status score
Description
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).
Time Frame
6 months post intervention
Title
Gingival health of the treated tooth as assessed by gingival status score
Description
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).
Time Frame
9 months post intervention
Title
Gingival health of the treated tooth as assessed by gingival status score
Description
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).
Time Frame
12 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathanael O Salako, BDS,MSc
Phone
(713) 486-4141
Email
Nathanael.O.Salako@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Jung
Phone
713-486-4026
Email
Sandra.Jung@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathanael O Salako, BDS,MSc
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathanael O Salako, BDS,MSc
Phone
713-486-4141
Email
Nathanael.O.Salako@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sandra Jung
Phone
713-486-4026
Email
Sandra.Jung@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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