Dental Caries in Children, Dental Treatment, Paediatric Dentistry
Conditions
Keywords
Hall crown, Stainless steel crowns, Minimally invasive caries management, biologic caries management, paediatric dentistry
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.
Interventions
PROCEDUREHall Crown Technique
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation.
PROCEDUREModified Hall Technique
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation but with interproximal slicing.
Sponsors
Jordan University of Science and Technology
King Abdullah University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Split mouth randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child acceptance of treatment | immediately following intervention | Self-reported child acceptance using questionnaire |
| 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 |
| Rate of radiographic Success | 12 months | Absence of radiographic pathology in the root and the bone in the inter-radicular area. |
| Parent acceptance of treatment | immediately following intervention | Parental acceptance using questionnaire |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time taken for intervention | during intervention | Time taken for intervention |
Countries
Jordan
Outcome results
None listed