Health TrialsbyHealthPanel

Clinical Performance of Two HEMA-Free Universal Adhesive Systems

ConditionCervical Caries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Two-bottle HEMA-free Universal AdhesiveExperimental treatment 1 intervention
Group B: One-bottle HEMA-free Universal AdhesiveActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: