Clinical trial NCT04822233: 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
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries
Keywords: molars
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 132
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Success as assessed by number of participants with no coronal or peri-radicular pathology
timeFrame: 3 months post intervention
measure: Success as assessed by number of participants with no coronal or peri-radicular pathology
timeFrame: 6 months post intervention
measure: Success as assessed by number of participants with no coronal or peri-radicular pathology
timeFrame: 9 months post intervention
measure: Success as assessed by number of participants with no coronal or peri-radicular pathology
timeFrame: 12 months post intervention
measure: Amount of time taken to complete the intervention
timeFrame: from start of intervention to end of intervention (about 45 minutes to 11/2 hours)
Secondary outcomes:
measure: Number of participants with occlusal contact of the molars as assessed by the strip test
timeFrame: 3 months post intervention
measure: Number of participants occlusal contact of the molars as assessed by the strip test
timeFrame: 6 months post intervention
measure: Number of participants occlusal contact of the molars as assessed by the strip test
timeFrame: 9 months post intervention
measure: Number of participants occlusal contact of the molars as assessed by the strip test
timeFrame: 12 months post intervention
measure: Molar height in occlusion
timeFrame: 3 months post intervention
measure: Molar height in occlusion
timeFrame: 6 months post intervention
measure: Molar height in occlusion
timeFrame: 9 months post intervention
measure: Molar height in occlusion
timeFrame: 12 months post intervention
measure: Anterior occlusal contact
timeFrame: 3 months post intervention
measure: Anterior occlusal contact
timeFrame: 6 months post intervention
measure: Anterior occlusal contact
timeFrame: 9 months post intervention
measure: Anterior occlusal contact
timeFrame: 12 months post intervention
measure: Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
timeFrame: 3 months post intervention
measure: Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
timeFrame: 6 months post intervention
measure: Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
timeFrame: 9 months post intervention
measure: Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
timeFrame: 12 months post intervention
measure: Gingival health of the treated tooth as assessed by gingival status score
timeFrame: 3 months post intervention
measure: Gingival health of the treated tooth as assessed by gingival status score
timeFrame: 6 months post intervention
measure: Gingival health of the treated tooth as assessed by gingival status score
timeFrame: 9 months post intervention
measure: Gingival health of the treated tooth as assessed by gingival status score
timeFrame: 12 months post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nathanael O Salako, BDS,MSc
role: PRINCIPAL_INVESTIGATOR
References: