Assessment of post-operative discomfort and effect on occlusion after placing Stainless Steel Crown by Halls technique vs Conventional technique: A Randomised Control Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- 1. To assess the presence of patient discomfort, and pain in the tooth and Temporomandibular Joint (TMJ) after placing Stainless Steel Crown (SSC) using Hall technique versus Conventional technique.
Study Overview
Brief Summary
Participants of dental caries ICDAS Scores 4 and 5 between the age group of 4-8 years will be divided into control and intervention groups. The control group will receive a 3M stainless steel crown after crown preparation. The intervention group will receive a 3M stainless steel crown without crown preparation. Clinical (pain in teeth and TMJ, overbite, intraoral vertical dimension, and midline deviation) and radiological (marginal adaptability) will be assessed in these patients with stainless steel crowns(SSCs) while using two different techniques. Clinical parameters will be evaluated at pre-op, immediate post-op, day after, 1st week, 2nd week, 3rd week, and 4th week post-operatively or at weekly intervals till occlusal settlement. Then at 3 months, 6 months, and 12 months. Marginal adaptability will be assessed using an IOPA X-ray immediately post-op. Loe and Silness Gingival index will be evaluated gingival health postoperatively and at every visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Cooperative Children of age between 4-8 years with Frankle Rating 3 and
- •First/Second deciduous molar teeth with occlusal and proximal caries diagnosed using the International Caries Detection, and Assessment System (ICDAS) with criteria codes 4 and 5 III.
- •Tooth with no symptom of pain.
- •Fully erupted tooth.
Exclusion Criteria
- •Any signs or symptoms of pulpal or periapical pathology.
- •Medically compromised Children.
- •Uncooperative children.
- •Inadequate crown structure unable to retain the crown.
- •Bruxism VI.
- •Tooth with abnormal mobility.
Outcomes
Primary Outcomes
1. To assess the presence of patient discomfort, and pain in the tooth and Temporomandibular Joint (TMJ) after placing Stainless Steel Crown (SSC) using Hall technique versus Conventional technique.
Time Frame: Clinical parameters will be evaluated at pre-op, immediate post-op, day after, 1st week, 2nd week, 3rd week, and 4th week post-operatively or at weekly intervals till occlusal settlement. Then at 3 months, 6 months, and 12 months.
2. To evaluate effects on occlusion such as overbite, midline deviations, and intraoral Occluso-vertical dimension.
Time Frame: Clinical parameters will be evaluated at pre-op, immediate post-op, day after, 1st week, 2nd week, 3rd week, and 4th week post-operatively or at weekly intervals till occlusal settlement. Then at 3 months, 6 months, and 12 months.
Secondary Outcomes
- 1. To assess the marginal adaptability of the SSC crown using an Intraoral Periapical (IOPA) Radiograph.(2. To evaluate the treatment time for placing SSC in both Halls & Conventional techniques.)
Investigators
Dr K Madhumita
All India Institute of Medical Sciences, Deoghar.