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NCT Number: NCT06545279

The Success Rate and Acceptability of Conventional and Modified Hall Crowns Among Children and Parents

This is a clinical trial that aims to compare the success rate, child and parent acceptance of conventional Hall crown technique (CHT) to modified Hall crown technique (MHT)in treating carious primary molars. Eligible children will receive CHT on one side and MHT on the other side. The time interval between both visits will be 1-2 weeks.Patients demographics and pain history will be recorded and pre-operative radiographs will be taken. An observer will assess and record the child's pain perception during each treatment visit. Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure. Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire. Clinical follow up will be conducted at 3,6 and 12 months to assess and compare the success rates of both techniques. Radiographs will be taken at 12 months to evaluate and compare radiographic success.

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This study is active but is not currently recruiting participants.

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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 split mouth randomized clinical trial that aims to compare the success rate, child and parent acceptance of conventional Hall crown technique (CHT) to modified Hall crown technique (MHT)in treating carious primary molars. Eligible children will receive CHT on one side and MHT on the other side. The time interval between both visits will be 1-2 weeks.Patients demographics and pain history will be recorded and pre-operative bitewings will be taken. An observer (research assistant who will be trained, calibrated, and blinded to the treatment used) will assess and record the child's pain perception during treatment visit. Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure. Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire. Clinical follow up will be conducted at 3,6 and 12 months to assess and compare the success rates of both techniques.Bitewings will be taken at 12 months to assess for crown fit and radiographic pathology.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fit and healthy (ASA 1) children.
  • 4-9 years old children.
  • Bilateral ICDAS (1, 2, 3 or 4) class I or II carious lesions on primary molars matched for tooth type.
  • Teeth with vital pulp with no signs or symptoms of irreversible pulpitis, necrosis, or an abscess.
  • No tenderness to percussion, or pathological mobility.
  • Prior bitewings must be available showing no radiographic evidence of interradicular radiolucency or caries reaching pulp.
  • Contact point is closed.
  • Patient has good level of cooperation for the intended procedure.
  • Parents consented for their children to be included in the study.

Exclusion criteria

  • Child with systemic illness (ASA 2,3,4).
  • Unmatched carious lesions on primary molars.
  • Teeth with deep caries (ICDAS score5 or 6) requiring pulp therapy.
  • Irreversible pulpitis or pulp necrosis.
  • Pathological mobility.
  • Prior bitewings are unavailable.
  • Contact point is open.
  • Patient has poor level of cooperation for the intended procedure.

Treatment and study plan

Hall Crown Technique

Procedure

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

Modified Hall Technique

Procedure

preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation but with interproximal slicing.

Primary outcomes

  1. Pain score

    Time frame: during intervention

    child's pain perception during intervention recorded by research assistant using sound,eyes and motor (SEM) scale

  2. Child discomfort score

    Time frame: immediately following intervention

    Self-reported Child's discomfort after intervention using Wong-Baker FACES Pain Rating Scale

  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: 6,12 months

    Absence of pain symptoms/ dental abscess requiring pulp therapy or extraction ,assessed through taking pain history and clinical examination

  6. Rate of radiographic Success

    Time frame: 12 months

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

Secondary outcomes

  1. Time taken for intervention

    Time frame: during intervention

    Time taken for intervention

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

Success Rate, Child and Parent Acceptance of Modified Hall Crowns Versus Conventional Hall Crowns:A Randomized Clinical Trial

Acronym: Hallcrowns

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
May 11, 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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