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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caries removal group | Experimental | Cavitated lesion will be isolated with cotton rolls and air-dried. Gel will be placed in the cavity and kept there for 60 seconds to allow for the decayed tissue to become softer. The softened tissue will be removed with a hand instrument. The gel will be reapplied, until complete removal of the carious tissue is achieved. Teeth will be restored using a high viscosity glass ionomer cement. |
|
| Caries arrest group | Active Comparator | Cavitated lesion will be isolated with cotton rolls and air-dried. One drop of component 1 (38% Silver Fluoride (AgF) in water) will be applied for 60 seconds using a microbrush, followed by two drops of component 2 (potassium iodide) for 90 seconds. Teeth will be restored using a high viscosity glass ionomer cement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRIX3000® | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical success | Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation. | 6 and 12 month post-treatment |
| radiographic success | Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation. | 12 month post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Longevity and the quality of the final restoration | Evaluation of retention, marginal integrity, marginal discoloration, anatomic form and secondary caries using USPHS criteria. | 6 and 12 months post-treatment |
| Patient's acceptance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sotiria Gizani, Assoc Prof | Contact | 2107461233 | sotiriagizani@gmail.com | |
| Kyriaki Seremidi, Assist Prof | Contact | kseremid@uoa.gr |
| Name | Affiliation | Role |
|---|---|---|
| Sotiria Gizani, Assoc Prof | Department Of Paediatric Dentistry, National And Kapodistrian University Of Athens | Principal Investigator |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Riva Star Aqua, SDI Limited, Australia | Other | 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. |
|
intensity or frequency of various symptoms, such as pain using the Visual Analogue Scale (VAS)
| immediately post-treatment |