This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars. Children aged 4-9 years old presenting with occlusal or proximal carious lesions of primary molars radiographically extending into the inner third or quarter of dentin will be invited to participate in this study. Patients will be randomized into two treatment groups using online block randomization technique (block of 6) and sealed envelope techniques. Time taken for clinical procedure will be recorded by a research assistant prospectively from the time the child sits on the dental chair till the end of procedure. Child pain perception will be recorded during intervention by a blinded research assistant using the Sound Eye Motor scale (SEM). Parental preference and child acceptance for each procedure will be recorded immediately after treatment using parent and child questionnaires. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.
Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC).
Jordan University of Science and Technology
Irbid, Jordan
Patient pain perception
will be evaluated by an observer (research assistant who will be trained, calibrated, and blinded to the treatment used) and recorded using the Sound, Eyes, and motor scale (SEM);Based on the intensity of the child's discomfort, each parameter is scored into one of four categories (comfort (score 0), mild discomfort (score 1), moderately painful (score 2), and painful (score 3)). The total score can range from 0 to 9, with 9 indicating the highest level of discomfort.
Time frame: Perioperatively
Rate of Radiographic Success
Absence of radiographic pathology in the root and the bone in the inter-radicular area.
Time frame: 6,12 months
Child acceptance of treatment
Self-reported child acceptance using questionnaire
Time frame: immediately following intervention
Parent acceptance of treatment
Parental acceptance using questionnaire
Time frame: immediately following intervention
Rate of Clinical Success
Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.
Time frame: 3,6,12 months
Time taken for intervention
Time taken for providing the intervention, measured in minutes
Time frame: Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed.
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