NCT04822233RecruitingNot Applicable
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.
The University of Texas Health Science Center, Houston2 sites in 1 country132 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 132
- Locations
- 2
- Primary Endpoint
- Amount of time taken to complete the intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame: 12 months post intervention
Secondary Outcomes
- Number of participants with occlusal contact of the molars as assessed by the strip test(3 months post intervention)
- Number of participants occlusal contact of the molars as assessed by the strip test(12 months post intervention)
- Molar height in occlusion(12 months post intervention)
- Biofilm around the stainless steel crown as assessed by the Modified Plaque Index(12 months post intervention)
- Anterior occlusal contact(12 months post intervention)
- Gingival health of the treated tooth as assessed by gingival status score(12 months post intervention)
Investigators
Nat Salako BDS(Hons)
Professor
The University of Texas Health Science Center, Houston
Study Sites (2)
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