Status
Conditions
Treatments
About
Dental caries, particularly in primary molars, significantly affects children's oral health and overall well-being. Traditional management with stainless steel crowns (SSCs) involves significant tooth reduction and advanced dental skills. Introduced in the 1970s, the Hall technique offers a less invasive alternative, minimizing tooth reduction compared to SSCs.
The SMART Hall technique represents a further evolution, emphasizing atraumatic cavity preparation using hand instruments. It offers advantages like minimal or no tooth reduction, minimized discomfort, improved patient cooperation, shorter treatment times, and cost-effectiveness.
Silver Diamine Fluoride (SDF) emerges as a promising non-invasive approach for managing dental caries in primary teeth, though it may cause temporary tooth discoloration. However, comparative evaluation with traditional SSC restorations remains limited.
To address this gap, a randomized clinical trial will evaluate the treatment outcomes of the SMART Hall technique versus conventional SSC restoration for managing occluso-proximal carious lesions (ICDAS CODE 3/4/5) in primary molars of young patients. Children aged 3 to 9 years requiring restorations will be included, assessing clinical outcomes, treatment time duration, and radiographical outcomes of both techniques at specific follow-up intervals of 3 months & 6 months.
This split mouth study will explore Clinical outcomes, radiographical outcomes, treatment time duration, and patient's pain perception with the chosen treatment modality. The findings will provide insights into the effectiveness and feasibility of the SMART Hall technique compared to the traditional SSC approach, informing evidence-based decision-making in pediatric dentistry and influencing treatment recommendations for preserving the health and function of primary molars in young children.
Full description
AIM OF THE STUDY The aim of this research study is to compare the treatment outcomes of the SMART Hall technique with conventional stainless steel crown (SSC) restoration for managing occluso-proximal carious lesions (ICDAS CODE 3/4/5) in primary molars of 3- to 9-year-old children.
OBJECTIVES OF THE STUDY
INCLUSION CRITERIA
EXCLUSION CRITERIA
METHODOLOGY Patients attending the Department Pedodontics & Preventive Dentistry department will be screened for identifying patients who fit into the inclusion & exclusion criteria. A total of 50 patients will be listed accordingly. Patients' parents / Guardian will be explained about the research study and treatments involved. Further, 25 patients will be randomly selected according to the determined sample size. Additional 5 patients will be recruited keeping in my the possibility of case attrition. A simple random selection method will be employed using Microsoft Excel program to generate patient pool to participate in this split mouth study.
Sampling method:
Probability sampling method, Simple Random sampling method using random number generators (RNGs)
Blinding:
Patients, Biostatistician and trained clinicians involved in evaluating clinical and radiographical outcomes will be kept blind about the type of treatment done in which primary tooth.
Training of examining clinicians:
To standardize the methods for training examiners in assessing clinical and radiographical outcomes, following steps will be followed:
Assessing inter-examiner and intra-examiner variability: Intraclass Correlation Coefficient (ICC) statistical test will be employed to check for both inter-examiner and intra-examiner variability.
Blinding of biostatistician: Blinding the biostatistician to the type of treatment modality to minimize potential bias in data analysis. Providing data labeled as "treatment modality 1" and "treatment modality 2" in the Excel sheet effectively conceals the treatment assignment from the biostatistician.
Criteria for Clinical Assessment are as follows:
Successful
Minor failure
Major failure
Clinical Parameters used in assessment are as follows:
Radiographical Parameters used in assessment are as follows:
The Visual Analogue Scale (VAS) will be utilized to evaluate patients' treatment experience.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Loading...
Central trial contact
Saraswathi Bai Pakkirawadi Katika, M.D.S
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal