Dental Caries
Conditions
Keywords
Dental caries, Hall technique, Indirect pulp capping, primary molars
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHall Technique
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.
PROCEDUREIndirect pulp capping
Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC).
Sponsors
King Abdullah University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* Fit and healthy. * Occlusal or proximal carious lesions on primary molars radiographically extending into the inner third or quarter of dentin. * Vital pulp with no signs or symptoms of irreversible pulpitis, necrosis, or an abscess. * No tenderness to percussion, or pathological mobility. * No radiographic evidence of interradicular/ periapical radiolucency. * Radiographic evidence of a radiopaque dentin layer between the radiolucent caries lesion and the dental pulp * Tooth is restorable. * Patient has good level of cooperation for the intended procedure. * Parents consented for their children to be included in the study.
Exclusion criteria
* Medically compromised children. * Irreversible pulpitis or pulp necrosis. * Soft and/or hard tissue pathology. * Furcal/ periapical pathology. * Root resorption exceeding one third of the root. * Pathological mobility. * Patient has poor level of cooperation for the intended procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient pain perception | Perioperatively | 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. |
| Rate of Radiographic Success | 6,12 months | Absence of radiographic pathology in the root and the bone in the inter-radicular area. |
| Child acceptance of treatment | immediately following intervention | Self-reported child acceptance using questionnaire |
| Parent acceptance of treatment | immediately following intervention | Parental acceptance using questionnaire |
| Rate of Clinical Success | 3,6,12 months | Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time taken for intervention | Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed. | Time taken for providing the intervention, measured in minutes |
Countries
Jordan
Outcome results
None listed