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Enrolling by Invitation

NCT Number: NCT07136155

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

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.

Enrolling by Invitation

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hall technique

Procedure

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

Indirect pulp capping

Procedure

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

Primary outcomes

  1. Patient pain perception

    Time frame: Perioperatively

    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.

  2. Rate of Radiographic Success

    Time frame: 6,12 months

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

  3. Child acceptance of treatment

    Time frame: immediately following intervention

    Self-reported child acceptance using questionnaire

  4. Parent acceptance of treatment

    Time frame: immediately following intervention

    Parental acceptance using questionnaire

  5. Rate of Clinical Success

    Time frame: 3,6,12 months

    Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.

Secondary outcomes

  1. Time taken for intervention

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

    Time taken for providing the intervention, measured in minutes

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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