An interventional study of Hall Technique (HT) and Modified Hall Technique (MHT) in Dental Caries, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
1,107 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's planned enrollment of 132 is above the median of 60 across 915 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Hall Technique (HT)
Device: Modified Hall Technique (MHT)
Device: Conventional Technique (CT)
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.
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.
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post intervention
Molar height in occlusion
Time frame: 3 months post intervention
Molar height in occlusion
Time frame: 6 months post intervention
Molar height in occlusion
Time frame: 9 months post intervention
Molar height in occlusion
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 months post intervention
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Health Science Center, Houston