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

NCT ID: NCT06545279

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2025-12-31

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.

Conditions

Paediatric Dentistry; Dental Caries in Children; Dental Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hall Crown Technique

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

Group Type: EXPERIMENTAL

Hall Crown Technique

Intervention Type: PROCEDURE

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

Modified Hall Technique

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

Group Type: EXPERIMENTAL

Modified Hall Technique

Intervention Type: PROCEDURE

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

Interventions

Hall Crown Technique

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

Intervention Type: PROCEDURE

Modified Hall Technique

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

King Abdullah University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Areej YA Alqadi, Dr

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Ola Al-Batayneh, Prof

Role: STUDY_CHAIR

Jordan University of Science and Technology

Locations

Jordan University of Science and Technology

Irbid, , Jordan

Countries

Jordan

Other Identifiers

20230328

Identifier Type: -

Identifier Source: org_study_id