A Phase 3 interventional study of SDF and SDF + ART (SMART technique ) in Dental Caries, sponsored by Ola Adel Abdelfadil Ahmed. Status unknown. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by Ola Adel Abdelfadil Ahmed · Phase 3, Interventional, and Treatment
This study aimed to evaluate the oral health related quality of life ( OHRQoL), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using SDF alone or SDF in combination with ART, using Early Childhood Oral Health Impact Scale (ECOHIS).
Early childhood caries (ECC) is a type of dental caries in the teeth of infants and children that is represented as one of the most prevalent dental problems in this period, which can lead to pain, infection, interference with eating.
According to the ADA, (ECC) is described as "the presence of one or more decayed ( cavitated or non cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth" in children.
Overall, 50% of children have one or more decayed primary teeth by the end of toddler age, but the importance of these teeth should not be neglected, because, healthy teeth in childhood have an important role in the eruption of healthy permanent teeth, healthy nutrition, and aesthetic appearance.
Conventional treatment methods (drill and fill) involve the use of rotary burs under local anesthesia which develops pain and needs cooperative child and highly trained dental health personnel and consider an invasive technique, on the other hand (ART) is an approach to increase accessibility to restorative treatment, inexpensive and can be employed in regions without electricity and running water. In addition, ART is a minimally invasive treatment that requires no rotary instruments or local anesthesia to remove decayed tissue before sealing the cavity with high viscosity glass ionomer cement (GIC).
(SDF), a low-cost cariostatic agent and a noninvasive method for caries management, treatment with SDF are easy, effective, and well accepted, it is also an alternative to traditional restorative treatment and may influence the reduction of untreated carious lesions in childhood
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →This is the only study on the registry with Ola Adel Abdelfadil Ahmed as lead sponsor.
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Inclusion Criteria: • Age: 4-6 years old age.
Exclusion Criteria:
Other: SDF
Other: SDF + ART (SMART technique )
1. Group 1: cleaning the occlusal surface to be treated with toothbrush. Decayed tissue from the affected teeth will not be removed for the SDF group. Clinical procedure for SDF application: it will apply according to the SDF manufacturer Instructions as follows:(1) the surrounding gingival tissues and lips will be protected with petroleum jelly to avoid staining and irritation,(2) the affected tooth will be isolated and keep dry with cotton rolls and saliva ejectors, (3) one drop of SDF (SDI RIVA STAR ), will be placed into a disposable dish, (4) SDF will be applied with a micro-sponge directly to the affected tooth surface(s), (5) allowed to soak in for 2 min, then air-dried. Then will be followed by the Potassium iodide (KI) liquid to decrease discoloration caused by SDF. The KI liquid will be reapplied until no more white perception observed to form.
2. Group 2: SDF+ART clinical procedure: (1)cleaning the occlusal surface to be treated with toothbrush.,(2) carious dentin will be removed using a small excavator (Spoon excavator ),(3) the cavity will be cleaned and dried, (4)cavity walls and floor will be conditioned for 10s, then washed and dried, (5) SDF will be applied as mentioned above followed by cavity restoration using resin-reinforced glass ionomer restorative material (SDI RIVA ).
ECOHIS
Early Childhood Oral Health Impact Scale.
Time frame: 6 month
- Clinical effectiveness Caries arrestment/ treatment
International Caries Detection and Assessment System (ICDAS II)
Time frame: 6 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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