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.

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.

Study Overview

• Status: Completed
• Conditions: Adhesive System
• Intervention / Treatment: Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS; Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:; Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14040-904
      • Ribeirão Preto School of Dentistry of the University of São Paulo (FORP-USP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older
• Occlusal stability supported by molars, Presence of at least one premolar or one molar with Class I/II cavities suitable for direct restoration or restoration replacement
• Ability to attend evaluation and regular maintenance appointments
• No clinical symptoms or radiographic signs suggesting pulp involvement
• No periodontal pockets or compromised biological space invasion
• Ability to perform absolute isolation of the operative field and subsequent restoration of the cavity with composite resin
• Active carious lesion
• Occlusal/occlusoproximal surface of molars and premolars, with a radiographic image showing shallow, medium, or deep dentin involvement, which is preventing the patient from effectively controlling bacterial biofilm, or showing some type of sensitivity
• Cavity preparation margins (cavosurface) in enamel or dentin.

Exclusion Criteria:

• Poor oral hygiene control
• Patients undergoing orthodontic treatment
• Pregnant or lactating women
• Oral complications such as: bruxism, other parafunctional habits reinforcing the diagnosis of TMD (temporomandibular disorders), periodontal problems
• Pregnant or breastfeeding women
• Presence of uncontrolled systemic diseases
• Patients at high risk for caries.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CI: Class I cavities restored with the total acid-etching technique.; Class I cavities restored with the total acid-etching technique.	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 Names: total-etch technique
Experimental: CII: Class II cavities restored with the total acid-etching technique.; Class II cavities restored with the total acid-etching technique.	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 Names: total-etch technique
Experimental: TI: Class I cavities restored with the self-etching technique.; Class I cavities restored with the self-etching technique.	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 Names: self-etch technique
Experimental: TII: Class II cavities restored with the self-etching technique.; Class II cavities restored with the self-etching technique.	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 Names: self-etch technique
Experimental: TIII: Class I cavities restored with the select-etching technique.; Class I cavities restored with the select-etching technique	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).; Other Names: selective acid-etch technique
Experimental: TIV: Class II cavities restorCed with the select-etching technique.; 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 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).; Other Names: selective acid-etch technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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).	baseline, six months, and one year.

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: randomized clinical trial; adhesive system
• Other Study ID Numbers: 61246422.4.0000.5498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No