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Not yet recruiting NCT07731061

Clinical Performance of Two HEMA-Free Universal Adhesive Systems

No phase Interventional Cervical Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: G2-Bond Universal, BeautiBond Xtreme Universal Adhesive.
Who it may be relevant to
Registry conditions: Cervical Caries. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Performance of One-Bottle Versus Two-Bottle HEMA- Free Universal Adhesives in Restoring Anterior Cervical Carious Lesions: A 12-Month Randomized Controlled Trial

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.

Detailed description

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.

Interventions

  • Device G2-Bond Universal
    Two-bottle HEMA-free universal adhesive system used in self-etch mode for restoring anterior cervical carious lesions according to the manufacturer's instructions.
  • Device BeautiBond Xtreme Universal Adhesive
    One-bottle HEMA-free universal adhesive system (Shofu Inc.) used in self-etch mode for restoring anterior cervical carious lesions according to the manufacturer's instructions.

Primary outcome measures

  • Restoration retention [Time frame: 12 Months]
Secondary outcome measures (3)
  • Marginal adaptation [Time frame: 12 months]
  • Marginal discoloration [Time frame: 12 months]
  • Postoperative sensitivity [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07731061 · CairoU-CONS-2026-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗