An interventional study of Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS and Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS: in Adhesive System, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Class I cavities restored with the total acid-etching technique.
Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS
Class II cavities restored with the total acid-etching technique.
Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS
Class I cavities restored with the self-etching technique.
Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:
Class II cavities restored with the self-etching technique.
Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:
Class I cavities restored with the select-etching technique
Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS
Class II cavities restorCed with the select-etching technique.
Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-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).
Also known as: total-etch technique
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).
Also known as: self-etch technique
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).
Also known as: selective acid-etch technique
Anatomic Form
The anatomic form of the restoration was evaluated according to the modified United States Public Health Service (USPHS) criteria at baseline, six months, and one year. Restorations were classified as Alpha (continuity of the restoration with the existing anatomic form), Bravo (continuity of the restoration with partial degradation but clinically acceptable), or Charlie (continuity of the restoration compromised, requiring replacement).
Time frame: baseline, six months, and one year.
Marginal Adaptation
Marginal adaptation was visually analyzed using an explorer to detect crevices or marginal failures. Classifications included Alpha (no visible evidence of a crevice along the margin), Bravo (visible evidence of a crevice along the margin where the explorer can penetrate or catch), and Charlie (the explorer penetrates the crevice, exposing dentin or base).
Time frame: baseline, six months, and one year.
Marginal Discoloration
Marginal discoloration was assessed by recording any color changes at the interface between the restoration and tooth structure. Restorations were classified as Alpha (no visible discoloration), Bravo (discoloration present but not penetrating along the margin in a pulpal direction), or Charlie (deep discoloration penetrating along the margin toward the pulp).
Time frame: baseline, six months, and one year.
Secondary Caries
The presence of secondary caries was clinically and radiographically evaluated throughout the study. Restorations were classified as Alpha (no evidence of secondary caries) or Charlie (evidence of secondary caries around the restoration, requiring replacement).
Time frame: baseline, six months, and one year.
Color Match
Color match was evaluated by comparing the restoration to the adjacent tooth structure in terms of color and translucency. Classifications included Alpha (color and translucency compatible with the tooth structure), Bravo (color and translucency mismatch within the acceptable range), and Charlie (color and translucency mismatch outside the acceptable range).
Time frame: baseline, six months, and one year.
Postoperative Sensitivity
Postoperative sensitivity was assessed through patient reports at different study periods. Classifications included Alpha (no postoperative sensitivity after the restorative procedure and throughout the study), Bravo (slight sensitivity at any stage of the study), and Charlie (severe sensitivity at any stage of the study).
Time frame: baseline, six months, and one year.
Surface Texture
The surface texture of the restoration was visually and tactilely evaluated using an explorer. Restorations were classified as Alpha (no surface defects), Bravo (minimal surface defects), or Charlie (severe surface defects on the restoration).
Time frame: baseline, six months, and one year.
Retention
Retention was evaluated by verifying the presence of the restoration over time. Classifications included Alpha (no loss of restorative material) and Charlie (fracture and/or total loss of the restorative material).
Time frame: baseline, six months, and one year.
Plan to share: Yes
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University of Sao Paulo