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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGSuccess 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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