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

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Group Type EXPERIMENTAL

Hall Technique

Intervention Type PROCEDURE

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)

Group Type EXPERIMENTAL

Indirect pulp capping

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Indirect pulp capping

Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdullah University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jordan University of Science and Technology

Irbid, , Jordan

Site Status

Countries

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Jordan

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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