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Trials / Active Not Recruiting

Active Not RecruitingNCT06545279

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
121 (actual)
Sponsor
King Abdullah University Hospital · Academic / Other
Sex
All
Age
4 Years – 9 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREHall Crown Techniquepreformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation.
PROCEDUREModified Hall Techniquepreformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation but with interproximal slicing.

Timeline

Start date
2023-08-04
Primary completion
2024-12-31
Completion
2025-12-31
First posted
2024-08-09
Last updated
2025-05-11

Locations

1 site across 1 country: Jordan

Source: ClinicalTrials.gov record NCT06545279. Inclusion in this directory is not an endorsement.