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

Not Applicable

Completed

• Conditions: Adhesive System

• Registration Number: NCT06899386
• Lead Sponsor: University of Sao Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-04-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anatomic Form	baseline, six months, and one year.	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).
Marginal Adaptation	baseline, six months, and one year.	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).
Marginal Discoloration	baseline, six months, and one year.	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).
Secondary Caries	baseline, six months, and one year.	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).
Color Match	baseline, six months, and one year.	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).
Postoperative Sensitivity	baseline, six months, and one year.	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).
Surface Texture	baseline, six months, and one year.	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).
Retention	baseline, six months, and one year.	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).

Trial Locations

Locations (1)

Ribeirão Preto School of Dentistry of the University of São Paulo (FORP-USP); 🇧🇷 Ribeirão Preto, São Paulo, Brazil