NCT06899386

Evaluation Of the BEAUTIBOND XTREME Adhesive in Class I and II Restorations: One-Year Results.

A Randomized Prospective Clinical Study Evaluating the Effectiveness of the BEAUTIBOND XTREME Adhesive System Using Different Bonding Techniques in Class I and II Restorations: One-Year Results.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial aimed to evaluate the performance of the Beautibond Xtreme adhesive system under different bonding techniques. Patients over 18 years old with restorative needs were selected, and 152 teeth were randomized using the "Research Randomizer Program" for allocation into control groups (CI - Class I restoration with total-etch conditioning; CII - Class II restoration with total-etch conditioning) and test groups (TI - Class I restoration in self-etch mode; TII - Class II restoration in self-etch mode; TIII - Class I restoration with selective enamel etching; TIV - Class II restoration with selective enamel etching). The restorations were evaluated (USPHS criteria) regarding anatomy, integrity, marginal staining, color, roughness, secondary caries lesions, postoperative sensitivity, and retention. Two calibrated examiners (Kappa test 0.84), blinded to the treatments, conducted evaluations for up to one year.

Conditions

• Adhesive System

Interventions

Type	Name	Description
OTHER	Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS	the enamel was etched for 30 seconds and the dentin for 15 seconds using 35% phosphoric acid gel (Ultradent). The acid was then rinsed off, and excess moisture was removed with an air spray. To protect the dentin during air blasting, an absorbent paper was held over it using clinical tweezers, ensuring a whitish appearance for the enamel and slightly moist dentin. Excess water on the cotton roll was dried as well. The BeautiBond Xtreme adhesive system was applied without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. Finally, the adhesive was light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent).
OTHER	Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:	no acid etching was performed on either the enamel or dentin. The BeautiBond Xtreme adhesive system was applied immediately, without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. The adhesive was then light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent).
OTHER	Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS	the enamel was etched for 15 seconds using 35% phosphoric acid gel (Ultradent). The acid was then rinsed off, and excess moisture was removed with an air spray, leaving the enamel with a whitish appearance. Excess water on the cotton roll was also dried. Next, the BeautiBond Xtreme adhesive system was applied immediately, without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. The adhesive was then light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent).

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-10-01
• Completion: 2024-04-01
• First posted: 2025-03-28
• Last updated: 2025-03-28

Locations

1 site across 1 country: Brazil