Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars.
NCT ID: NCT07136155
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
120 participants
INTERVENTIONAL
2024-09-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hall Crown Technique
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.
Hall Technique
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.
Indirect pulp capping
Selective caries removal to firm dentin followed by placing RMGI base material and subsequent preformed metal crown (PMC)
Indirect pulp capping
Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC).
Interventions
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Hall Technique
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.
Indirect pulp capping
Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
9 Years
ALL
No
Sponsors
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King Abdullah University Hospital
OTHER
Responsible Party
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Locations
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Jordan University of Science and Technology
Irbid, , Jordan
Countries
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Other Identifiers
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20240506
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
414 - 2024
Identifier Type: -
Identifier Source: org_study_id
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