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

NCT07136155 | Enrolling By Invitation DMC

• 2 other identifiers: 414 - 202420240506
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Dental caries; Hall technique; Indirect pulp capping; primary molars

Outcome Measures

Primary Outcomes (5)

• 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.

  Perioperatively

• Rate of Radiographic Success

  Absence of radiographic pathology in the root and the bone in the inter-radicular area.

  6,12 months

• Child acceptance of treatment

  Self-reported child acceptance using questionnaire

  immediately following intervention

• Parent acceptance of treatment

  Parental acceptance using questionnaire

  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.

  3,6,12 months

Secondary Outcomes (1)

• Time taken for intervention

  Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed.

Study Arms (2)

Hall Crown Technique

EXPERIMENTAL

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

Procedure: Hall Technique

Indirect pulp capping

EXPERIMENTAL

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

Procedure: Indirect pulp capping

Interventions

Hall Technique PROCEDURE

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

Hall Crown Technique

Indirect pulp capping PROCEDURE

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

Indirect pulp capping

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

JO (1)