Comparative Evaluation of Clinical and Radiographic Success of Three Stainless Steel Crown Techniques in Primary Mandibular Molars and Oral Health related Quality of Life Assessment: A Prospective, Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Determining the clinical and radiographic success or failure of stainless steel crown placement after a 12 month period.
Study Overview
Brief Summary
This study Is a prospective, randomised, parallel-group clinical trial comparing the clinical and radiographic outcomes of placement of stainless steel crown with Hall, Modified Hall and conventional techniques in cavitated primary mandibular molars. Pediatric patients reporting to the Department of Pediatric and Preventive Dentistry, SRIHER, who meet the inclusion criteria will be recruited. Children who meet the inclusion criteria will be randomly allocated to either of the 3 groups based on the randomization list. Study group (Group A): Hall technique Study group (Group B): Modified Hall technique Control group (Group C): Conventional technique The primary outcome of this study will be determining the success of the stainless steel crown placement after 12 months. To be categorized as having overall success, the evaluated tooth must demonstrate both clinical and radiographic success. Clinical and radiographic evaluation will be conducted at intervals of 1, 3, 6 and 12 months. Additionally, the oral health related quality of life of the children undergoing these techniques will be assessed using a modified version of the Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged 4-8 years Primary mandibular molars with cavitated Class I and II caries (with Remaining dentin thickness not less than 1 mm) Permanent 1st molar should be erupted if primary mandibular second molar is considered No signs of pulpal or periapical pathology, or internal or external resorption.
Exclusion Criteria
- •Presence of root resorption of more than one-third of root Presence of pulpal or periapical pathologies Presence of tooth mobility Children with underlying medical conditions or special healthcare needs Patients unwilling to participate.
Outcomes
Primary Outcomes
Determining the clinical and radiographic success or failure of stainless steel crown placement after a 12 month period.
Time Frame: Clinical and radiographic evaluation will be conducted at intervals of 1, 3, 6 and 12 months
The success of the crown placement will be assessed clinically for gingival health, plaque accumulation, marginal integrity, wear of the crown and occlusion. Radiographically, it will be assessed by the presence of secondary caries, furcation radiolucency, widening of periodontal ligament and bone resorption
Time Frame: Clinical and radiographic evaluation will be conducted at intervals of 1, 3, 6 and 12 months
Secondary Outcomes
- Assessing the oral health related quality of life of the patients undergoing stainless steel crown technique.(A modified version of the Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire will be administered to the parents at intervals of 1, 3, 6 and 12 months)
Investigators
Ishwarya S
Sri Ramachandra Dental College and Hospital