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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries in Children; Paediatric Dentistry; Dental Treatment
• Intervention / Treatment: Procedure: Hall Crown Technique; Procedure: Modified Hall Technique

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan
    • Jordan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hall Crown Technique; preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.	Procedure: Hall Crown Technique; preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation.
Experimental: Modified Hall Technique; preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal but with prior interproximal slicing on other side	Procedure: Modified Hall Technique; preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation but with interproximal slicing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken for intervention	Time taken for intervention	during intervention

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital
• Collaborators: Jordan University of Science and Technology
• Investigators: Principal Investigator: Areej YA Alqadi, Dr, Jordan University of Science and Technology; Study Chair: Ola Al-Batayneh, Prof, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: paediatric dentistry; Stainless steel crowns; Hall crown; Minimally invasive caries management; biologic caries management
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: 20230328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No