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

University of Sao Paulo

Status: Completed

Conditions: Adhesive System

Treatments: Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:; Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS; Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS

Study type: Interventional

Funder types: Other

Identifiers

NCT06899386

61246422.4.0000.5498

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

22 participants in 6 patient groups

CI: Class I cavities restored with the total acid-etching technique.

Experimental group

Description:

Class I cavities restored with the total acid-etching technique.

Treatment:

Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS

CII: Class II cavities restored with the total acid-etching technique.

Experimental group

Description:

Class II cavities restored with the total acid-etching technique.

Treatment:

Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS

TI: Class I cavities restored with the self-etching technique.

Experimental group

Description:

Class I cavities restored with the self-etching technique.

Treatment:

Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:

TII: Class II cavities restored with the self-etching technique.

Experimental group

Description:

Class II cavities restored with the self-etching technique.

Treatment:

Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:

TIII: Class I cavities restored with the select-etching technique.

Experimental group

Description:

Class I cavities restored with the select-etching technique

Treatment:

Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS

TIV: Class II cavities restorCed with the select-etching technique.

Experimental group

Description:

Class II cavities restorCed with the select-etching technique.

Treatment:

Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS