About this trial
This trial seeks to evaluate the periodontal health of two modalities Hall Technique (by placing a stainless steel crown without caries removal, local anaesthesia won't be needed) \& ART (by removing caries by sharp excavator and restoring the tooth with glass ionomer, local anaesthesia won't be needed either) to achieve better treatment for caries with pain-free procedures in developing countries that have high caries index and low income.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: From 4 to 6 years.
Caries in primary molars within enamel/dentin with vital pulp.
Healthy children.
Cooperative children.
Disqualifiers
Presence of signs and symptoms of necrosis.
Root caries.
History of Spontaneous pain.
Trial design
Parallel
Treatments tested in this trial
ART
Procedure/SurgeryCaries excavation with hand instruments only and restoration with glass ionomer filling
Hall technique
Procedure/SurgeryStainless steel crown placement without tooth preparation
Treatment groups
Trial outcomes
Primary outcomes
Periodontal health
While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) using plaque index (0: no plaque, 2: thick visible plaque easily detected)
Secondary outcomes
Gingival index
While determining the plaque, the 4 surfaces of the teeth included in the study (mesial, distal, vestibule, lingual) (0= no swelling, 2= Moderate to severe gingival swelling, bleeding after air drying)
Postoperative pain and discomfort
Immediately after the treatment, any pain and discomfort experienced by the child will be recorded using the Face Pain Scale - revised (FPS-R) (0= no pain, 10=worst)
Child behaviour
Venham Anxiety Rating Scale (0= total cooperation, best possible working conditions, no crying or physical protest, 5= general protest, no cooperation, physical restraint is required)
Child anxiety
Venham Anxiety Rating Scale (0= relaxed, smiling, willing, and able to converse, 5= loud crying unable to listen to verbal communication)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: