Caries,Dental
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERBRIX3000®
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.
OTHERRiva Star Aqua, SDI Limited, Australia
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.
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 4 to 8 years with a non-contributary medical history and sufficient compliance for the caries treatment will be included. The eligible children should have at least two carious primary molars (cavitated lesions up to 2/3 of dentin, corresponding to ICDAS 5 and 6) on different quadrants without any periapical pathology detected radiographically.
Exclusion criteria
* Children aged below 4 years and above 8 years, with compromised medical history and/or allergies, with clinical or radiographic signs or symptoms of pulp pathology and with developmental dental defects will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical success | 6 and 12 month post-treatment | Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation. |
| radiographic success | 12 month post-treatment | Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longevity and the quality of the final restoration | 6 and 12 months post-treatment | Evaluation of retention, marginal integrity, marginal discoloration, anatomic form and secondary caries using USPHS criteria. |
| Patient's acceptance | immediately post-treatment | intensity or frequency of various symptoms, such as pain using the Visual Analogue Scale (VAS) |
Contacts
Primary ContactSotiria Gizani, Assoc Prof
Backup ContactKyriaki Seremidi, Assist Prof
Outcome results
None listed