Clinical Performance of Two HEMA-Free Universal Adhesive Systems

NCT07731061 | Not Yet Recruiting DMC

• 1 other identifier: CairoU-CONS-2026-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Caries

Keywords

HEMA-Free Universal Adhesive; Cervical Carious Lesions; Modified USPHS; Universal Adhesive; Randomized Clinical Trial; Restorative Dentistry; One-step versus two-step HEMA free adhesives; BeautiBond Xtreme; G2-Bond Universal

Outcome Measures

Primary Outcomes (1)

• 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).

  12 Months

Secondary Outcomes (3)

• Marginal adaptation

  12 months

• Marginal discoloration

  12 months

• Postoperative sensitivity

  12 months

Study Arms (2)

Two-bottle HEMA-free Universal Adhesive

EXPERIMENTAL

Restoration of anterior cervical carious lesions using G2-Bond Universal (GC Corporation) in self-etch mode followed by Beautifil II LS composite resin.

Device: G2-Bond Universal

One-bottle HEMA-free Universal Adhesive

ACTIVE COMPARATOR

Restoration of anterior cervical carious lesions using BeautiBond Xtreme Universal Adhesive (Shofu) in self-etch mode followed by Beautifil II LS composite resin.

Device: BeautiBond Xtreme Universal Adhesive

Interventions

G2-Bond Universal DEVICE

Two-bottle HEMA-free universal adhesive system used in self-etch mode for restoring anterior cervical carious lesions according to the manufacturer's instructions.

Two-bottle HEMA-free Universal Adhesive

BeautiBond Xtreme Universal Adhesive DEVICE

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.

One-bottle HEMA-free Universal Adhesive

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to the allocated adhesive system. The operator cannot be blinded because the two adhesive systems require different clinical application protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Candidate in Restorative dentistry

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups to receive either a two-bottle HEMA-free universal adhesive system (G2-Bond Universal) or a one-bottle HEMA-free universal adhesive system (BeautiBond Xtreme). Clinical outcomes will be evaluated over a 12-month follow-up period.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07