Actively Recruiting
Comparison of the Treatment Outcomes of Conventional Stainless Steel Crown Restorations and the Hall Technique in Treating Carious Primary Molars
Led by Hue University of Medicine and Pharmacy · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children with dental caries in their primary molars to compare two methods of treating tooth decay: conventional stainless steel crown restorations and the Hall technique. The goal is to evaluate how effective each method is in managing carious primary molars. Stainless steel crowns have been shown to last longer than traditional fillings, and this study aims to assess these two approaches over time. The study involves two treatment groups. In one group, stainless steel crowns are placed after preparing the tooth, which includes caries removal and use of local anesthesia. In the other group, stainless steel crowns are placed using the Hall technique, which does not involve anesthesia, caries removal, or tooth preparation. Both procedures aim to restore decayed primary molars in children aged 3 to 9 years. Participants will be followed for up to 12 months, with evaluations at 3, 6, 9, and 12 months to monitor crown failure rates. Researchers will also assess occlusal contact and periodontal health at these intervals. The study uses a randomized and double-blind design to compare outcomes. Children and their guardians will be monitored for treatment effectiveness and dental health throughout the study period, which is expected to end in May 2026.
CONDITIONS
Brief Title
Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree and voluntarily participate with parent or guardian consent
- Children aged 3 to 9 years
- Have a primary molar with at least 2 carious lesions scoring 4 on the ICDAS or at least 1 carious lesion scoring 5 or 6 on the ICDAS
You will not qualify if you...
- Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders
- Children allergic to nickel or resin
- Children unable to return for recall visits
- Primary molar showing signs of irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess
- Children undergoing orthodontic treatment with fixed or removable appliances
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive a stainless steel crown on a carious primary molar either by conventional preparation or the Hall technique without local anesthesia or caries removal.
1 treatment visit and follow-up visits at 3, 6, 9, and 12 months
Trial Site Locations
Total: 1 location
1
Hue University of Medicine and Pharmacy
Huế, Thừa Thiên Huế Province, Vietnam, 49120
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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