A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars.
Fifty children (100 teeth) aged 4 to 8 years with a non-contributary medical history and at least two carious primary molars (ICDAS 5 and 6) on different quadrants will be randomly assigned to either treatment group, using computer-generated numbers. Each cavitated lesion will be isolated with cotton rolls and air-dried before being treated with one of the two types of minimal intervention technique according to the manufacturer's instructions. After the application of the agents all teeth will be restored using a high viscosity glass ionomer cement. Patients will be followed clinically at 6 and 12 months and radiographically at 12 months to evaluate success of the procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
A gel that when applied to the tooth completely removes carious tissues in a chemo mechanical way without rotary instruments. It contains an enzyme that has bactericidal, bacteriostatic and anti-inflammatory properties and proteolytic properties that help soften and break down decayed tissue without destroying the underlying healthy collagen fibers.
A solution that contains 44,800 ppm F and 253,870 ppm Ag. It acts as a fluoride storage for the acid challenges, while inhibites demineralization of hydroxyapatite crystals and preserves collagen from degradation in demineralized tissues.
clinical success
Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation.
Time frame: 6 and 12 month post-treatment
radiographic success
Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation.
Time frame: 12 month post-treatment
Longevity and the quality of the final restoration
Evaluation of retention, marginal integrity, marginal discoloration, anatomic form and secondary caries using USPHS criteria.
Time frame: 6 and 12 months post-treatment
Patient's acceptance
intensity or frequency of various symptoms, such as pain using the Visual Analogue Scale (VAS)
Time frame: immediately post-treatment
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