Clinical Performance of Two HEMA-Free Universal Adhesive Systems

N/ANot Yet RecruitingNCT07731061

Cairo University50 enrolled

Overview

This randomized controlled clinical trial aims to compare the 12-month clinical performance of two HEMA-free universal adhesive systems for restoring anterior cervical carious lesions. Participants will be randomly allocated (1:1) to receive restorations using either a two-bottle HEMA-free universal adhesive (G2-Bond Universal) or a one-bottle HEMA-free universal adhesive (BeautiBond Xtreme), both applied in self-etch mode. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, and postoperative sensitivity, evaluated at baseline (24 hours), 6 months, and 12 months using the modified USPHS criteria.

This single-center, parallel-arm, randomized controlled clinical trial will be conducted at the Department of Conservative Dentistry, Faculty of Dentistry, Cairo University. Fifty participants with ICDAS 3 or 4 anterior cervical carious lesions will be randomly assigned in a 1:1 ratio to receive restorations using either G2-Bond Universal (two-bottle HEMA-free universal adhesive) or BeautiBond Xtreme (one-bottle HEMA-free universal adhesive), both applied in self-etch mode and restored with Beautifil II LS composite resin. Clinical performance will be evaluated at baseline (24 hours), 6 months, and 12 months using the modified USPHS criteria. The primary outcome is restoration retention. Secondary outcomes include marginal adaptation, marginal discoloration, and postoperative sensitivity. Participants and outcome assessors will be blinded, while the operator cannot be blinded because of differences in the adhesive application protocols.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: . Patients aged from 18 to 55 years. * Patients with cervical carious lesions on the labial surfaces of anterior teeth. * Lesions classified as ICDAS 3 and 4. * Patients with good general health. * Patients able and willing to attend the follow-up visits at baseline, 6 months and 12 months. Exclusion Criteria: * Patients with severe or chronic periodontal disease. * Patients with poor oral hygiene or uncontrolled plaque accumulation. * Patients with bruxism or other parafunctional habits that may affect restoration survival. * Non-vital teeth. * Fractured or cracked teeth. * Teeth with defective existing cervical restorations. * Root caries extending beyond the restorative indication of the study. * Pregnant or lactating patients. * Patients with known allergy or hypersensitivity to any component of the adhesive systems or restorative material used in the study. * Patients unable to attend the scheduled follow-up visits.

Outcomes

Primary Outcomes

Restoration retention

Clinical assessment of restoration retention using the Modified United States Public Health Service (USPHS) criteria at baseline, 6 months, and 12 months. Retention will be recorded as ordinal categorical data using two categories: Alpha (complete restoration retention; best clinical outcome) and Charlie (partial or complete loss of the restoration requiring repair or replacement; worst clinical outcome and considered failure).

Time frame: 12 Months

Secondary Outcomes

Marginal adaptation

Clinical assessment of marginal adaptation using the Modified United States Public Health Service (USPHS) criteria at baseline, 6 months, and 12 months. Marginal adaptation will be recorded as ordinal categorical data using Alpha (closely adapted margins with no visible or detectable crevice; best clinical outcome), Bravo (visible crevice with explorer penetration but no exposed dentin; clinically acceptable), and Charlie (crevice with exposed dentin requiring repair or replacement; worst clinical outcome and considered failure).

Time frame: 12 months

Marginal discoloration

Clinical assessment of marginal discoloration using the Modified United States Public Health Service (USPHS) criteria at baseline, 6 months, and 12 months. Marginal discoloration will be recorded as ordinal categorical data using Alpha (no marginal discoloration; best clinical outcome), Bravo (marginal discoloration without axial/pulpal-direction penetration; clinically acceptable), and Charlie (marginal discoloration with axial/pulpal-direction penetration requiring clinical intervention; worst clinical outcome and considered failure).

Time frame: 12 months

Postoperative sensitivity

Clinical assessment of postoperative sensitivity using the Modified United States Public Health Service (USPHS) criteria at baseline, 6 months, and 12 months. Postoperative sensitivity will be recorded as ordinal categorical data using Alpha (absence of postoperative sensitivity; best clinical outcome), Bravo (slight postoperative sensitivity that is clinically acceptable and does not require intervention), and Charlie (persistent postoperative sensitivity requiring clinical intervention; worst clinical outcome and considered failure).

Time frame: 12 months

Clinical Performance of Two HEMA-Free Universal Adhesive Systems

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes