Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars.

King Abdullah University Hospital

Status: Invitation-only

Conditions: Dental Caries

Treatments: Procedure: Indirect pulp capping; Procedure: Hall Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07136155

20240506 (Other Grant/Funding Number)

414 - 2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Hall Crown Technique

Experimental group

Description:

preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.

Treatment:

Procedure: Hall Technique

Indirect pulp capping

Experimental group

Description:

Selective caries removal to firm dentin followed by placing RMGI base material and subsequent preformed metal crown (PMC)

Treatment:

Procedure: Indirect pulp capping