ClinicalTrials.gg
Not yet recruitingNCT07731061Updated Sep 8, 2026

Clinical Performance of Two HEMA-Free Universal Adhesive Systems

An interventional study of G2-Bond Universal and BeautiBond Xtreme Universal Adhesive in Cervical Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervical Caries

Browse trials for

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
03

In context

Root Caries

39 studies on the registry are indexed under Root Caries; 14 are open to participants now.

This study's planned enrollment of 50 is below the median of 62 across 35 interventional studies indexed under Root Caries.

Browse Root Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to any component of the adhesive systems or restorative material used in the study.
    • Patients unable to attend the scheduled follow-up visits.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Two-bottle HEMA-free Universal Adhesive

    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

  • Active comparator
    One-bottle HEMA-free Universal Adhesive

    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

  • DeviceG2-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.

  • DeviceBeautiBond 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.

06

What researchers measure

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).

    Time frame: 12 Months

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07731061
Lead sponsor
Cairo University
Responsible party
Mariam Salem (MSc Candidate in Restorative dentistry, Cairo University) — Principal investigator
First posted
Jul 28, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Sep 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion