Clinical trial NCT06545279: The Success Rate and Acceptability of Conventional and Modified Hall Crowns Among Children and Parents
Official title: Success Rate, Child and Parent Acceptance of Modified Hall Crowns Versus Conventional Hall Crowns:A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Paediatric Dentistry
Dental Caries in Children
Dental Treatment
Keywords: Hall crown
Stainless steel crowns
Minimally invasive caries management
biologic caries management
paediatric dentistry
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2024-08-09
Enrollment: 121
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Split mouth randomized clinical trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain score
timeFrame: during intervention
measure: Child discomfort score
timeFrame: immediately following intervention
measure: Child acceptance of treatment
timeFrame: immediately following intervention
measure: Parent acceptance of treatment
timeFrame: immediately following intervention
measure: Rate of clinical success
timeFrame: 6,12 months
measure: Rate of radiographic Success
timeFrame: 12 months
Secondary outcomes:
measure: Time taken for intervention
timeFrame: during intervention
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Areej YA Alqadi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordan University of Science and Technology
name: Ola Al-Batayneh, Prof
role: STUDY_CHAIR
References: