Clinical evaluation of a Monochromatic Flow Composite Resin of dental restoration

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: Sixty participants with two non‐carious cervical lesions side by side will undergo the interventions. There will be two groups (n=60). It is a randomized study. Randomization will be done intra‐individually so that each subject receives two restorations, one from each group. These randomization schemes will be carried out using a tool available on the website http://www.sealenvelope.com. A staff member not involved in the research protocol will perform the randomization process. Blinding: Double‐blind. Details of allocated groups will be recorded on cards contained in sequentially numbered, opaque and sealed envelopes. The envelope will only be opened on the day of the restorative procedure, ensuring the random sequence is hidden. In all cases, the tooth with the highest number of teeth (FDI numbering system) will receive the treatment described first, while the tooth with the next number in the sequence will receive the treatment mentioned second. The examiners will not be involved with the restoration procedures and therefore will not be aware of the group's task. The patient will also be blinded to group assignment in a double‐blind randomized controlled clinical trial. Participants received prophylaxis and cavity cleaning before the restorative procedure. The initial color measurement will be carried out before the intervention using silicone guides and a digital spectrophotometer. After measurements, patients will be locally anesthetized and the operative field will be isolated with absolute isolation. Acid conditioning of the teeth will be carried out with Condac 37 phosphoric acid (FGM) only in the selective form of enamel, after washing and drying; the cavities received Ambar Universal adhesive (FGM) according to the manufacturer's recommendations. The CONDITION: C07.793.818.124 Tooth Diseases PRIMARY OUTCOME: Evaluate color match using a digital spectrophotometer on the performance of a monochromatic composite versus a traditional composite in non‐carious cervical lesions. Interim data analyzes will be performed immediate and 6, 12, 24, 36 and 60 months. SECONDARY OUTCOME: Evaluate the aesthetic properties; functional properties and biological properties using the World Dental Federation (FDI) clinical criteria on the performance of a monochromatic composite versus a traditional composite in non‐carious cervical lesions. Interim data analyzes will be performed immediate and 6, 12, 24, 36 and 60 months. INCLUSION CRITERIA: Good general health;good oral hygiene;present at least 20 teeth under occlusion;at least two non‐carious cervical lesions comparable in size;format and dimensions;non‐retentive;deeper than half a mm;and involve both the enamel and dentin of vital teeth;The cavo‐superficial margin cannot involve more than 50% of the enamel
Epistemonikos ID: 8891a8cbe88f3ac226e11813d22c9c71ba1d968a
First added on: Aug 26, 2024