Clinical trial NCT05188846: Caries Arresting in Primary Molar Teeth Using SDF VS ART
Official title: Caries Arresting Treatment Using Silver Diamine Fluoride (SDF) Versus SDF Modified Atraumatic Restorative Technique (SMART) for Management of Carious Vital Primary Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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

Eligibility criteria: Inclusion Criteria: • Age: 4-6 years old age.

* Both genders.
* Decayed vital primary molars (asymptomatic teeth with active single-surface lesions, vital pulp no signs of irreversible pulpitis) .

Exclusion Criteria:

* History of systemic conditions.
* Allergy to silver.
* Oral ulceration.
* Teeth with proximal or multi-surfaces caries, pulp pathology.

Primary outcomes:
measure: ECOHIS
timeFrame: 6 month
Secondary outcomes:
measure: - Clinical effectiveness Caries arrestment/ treatment
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Nevine Waly, Professor
role: STUDY_CHAIR
References: