Clinical trial NCT06899386: Evaluation Of the BEAUTIBOND XTREME Adhesive in Class I and II Restorations: One-Year Results.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive System
Keywords: adhesive system
randomized clinical trial
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anatomic Form
timeFrame: baseline, six months, and one year.
measure: Marginal Adaptation
timeFrame: baseline, six months, and one year.
measure: Marginal Discoloration
timeFrame: baseline, six months, and one year.
measure: Secondary Caries
timeFrame: baseline, six months, and one year.
measure: Color Match
timeFrame: baseline, six months, and one year.
measure: Postoperative Sensitivity
timeFrame: baseline, six months, and one year.
measure: Surface Texture
timeFrame: baseline, six months, and one year.
measure: Retention
timeFrame: baseline, six months, and one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Ribeirão Preto School of Dentistry of the University of São Paulo (FORP-USP)
state: São Paulo
Study officials:
References: