Enrolling by invitation NCT07136155

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

No phase Interventional Dental Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Hall Technique, Indirect pulp capping.
Who it may be relevant to: Registry conditions: Dental Caries. Basic parameters: 4 years — 9 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Jordan
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Official title

Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars: A Randomized Controlled Trial.

Overview

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

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

Procedure Hall Technique
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.
Procedure Indirect pulp capping
Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC).

Primary outcome measures

Patient pain perception [Time frame: Perioperatively]
Rate of Radiographic Success [Time frame: 6,12 months]
Child acceptance of treatment [Time frame: immediately following intervention]
Parent acceptance of treatment [Time frame: immediately following intervention]
Rate of Clinical Success [Time frame: 3,6,12 months]

Secondary outcome measures (1)

Time taken for intervention [Time frame: Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

Jordan · 1 center

Jordan University of Science and Technology — Irbid

Identifiers

NCT: NCT07136155 · 414 - 2024 · 20240506

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗