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

Not Applicable

Active, not recruiting

• Conditions: Paediatric Dentistry; Dental Caries in Children; Dental Treatment
• Interventions: Procedure: Modified Hall Technique; Procedure: Hall Crown Technique

• Registration Number: NCT06545279
• Lead Sponsor: King Abdullah University Hospital

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.

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 Timeline

• Study Start: 2023-08-04
• Study First Submitted: 2024-06-09
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Primary Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Modified Hall Technique	Modified Hall Technique	preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal but with prior interproximal slicing on other side
Hall Crown Technique	Hall Crown Technique	preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.

Primary Outcome Measures

Name	Time	Method
Pain score	during intervention	child's pain perception during intervention recorded by research assistant using sound,eyes and motor (SEM) scale
Child discomfort score	immediately following intervention	Self-reported Child's discomfort after intervention using Wong-Baker FACES Pain Rating Scale
Child acceptance of treatment	immediately following intervention	Self-reported child acceptance using questionnaire
Parent acceptance of treatment	immediately following intervention	Parental acceptance using questionnaire
Rate of radiographic Success	12 months	Absence of radiographic pathology in the root and the bone in the inter-radicular area.
Rate of clinical success	6,12 months	Absence of pain symptoms/ dental abscess requiring pulp therapy or extraction ,assessed through taking pain history and clinical examination

Secondary Outcome Measures

Name	Time	Method
Time taken for intervention	during intervention	Time taken for intervention

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan