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

NCT06545279 | Active Not Recruiting

• 1 other identifier: 20230328
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Paediatric Dentistry; Dental Caries in Children; Dental Treatment

Keywords

Hall crown; Stainless steel crowns; Minimally invasive caries management; biologic caries management; paediatric dentistry

Outcome Measures

Primary Outcomes (6)

• Pain score

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

  during intervention

• Child discomfort score

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

  immediately following intervention

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

  6,12 months

• Rate of radiographic Success

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

  12 months

Secondary Outcomes (1)

• Time taken for intervention

  during intervention

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 Crown Technique

Modified Hall Technique

EXPERIMENTAL

preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal but with prior interproximal slicing on other side

Procedure: Modified Hall Technique

Interventions

Hall Crown Technique PROCEDURE

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

Hall Crown Technique

Modified Hall Technique PROCEDURE

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

Modified Hall Technique

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Fit and healthy (ASA 1) children.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

Location

Study Officials

• Areej YA Alqadi, Dr

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Ola Al-Batayneh, Prof

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

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

Model Details: Split mouth randomized clinical trial.

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: August 9, 2024
• Study Start: August 4, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)