Cervical CariesNCT07731061
Clinical Performance of Two HEMA-Free Universal Adhesive Systems
A study testing G2-Bond Universal and BeautiBond Xtreme Universal Adhesive in people with Cervical Caries, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cervical Caries
- What is being tested?
- G2-Bond Universal and BeautiBond Xtreme Universal Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- . 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
About this study
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
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.
- Conditions
- Cervical Caries
- Being tested
- G2-Bond Universal, BeautiBond Xtreme Universal Adhesive
- 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
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G2-Bond UniversalDevice
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 AdhesiveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: BeautiBond Xtreme Universal Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 Months
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Salem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731061
- Sponsor's protocol ID
- CairoU-CONS-2026-001
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07731061
- Acronym / sponsor ID
- CairoU-CONS-2026-001
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Two-bottle HEMA-free Universal Adhesive | Experimental | Device: G2-Bond UniversalRestoration of anterior cervical carious lesions using G2-Bond Universal (GC Corporation) in self-etch mode followed by Beautifil II LS composite resin. |
| One-bottle HEMA-free Universal Adhesive | Active comparator | Device: BeautiBond Xtreme Universal AdhesiveRestoration of anterior cervical carious lesions using BeautiBond Xtreme Universal Adhesive (Shofu) in self-etch mode followed by Beautifil II LS composite resin. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- . 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.
Key exclusion criteria (10 listed)
- Patients with severe or chronic periodontal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G2-Bond UniversalTwo-bottle HEMA-free universal adhesive system used in self-etch mode for restoring anterior cervical carious lesions according to the manufacturer's instructions. | Device | Two-bottle HEMA-free Universal Adhesive |
| BeautiBond Xtreme Universal AdhesiveOne-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. | Device | One-bottle HEMA-free Universal Adhesive |
Primary outcome
Restoration retention
Time frame: 12 Months
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).
3 secondary outcomes
Marginal adaptation
Time frame: 12 months
Marginal discoloration
Time frame: 12 months
Postoperative sensitivity
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Related trials for Cervical Caries
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Recruiting
Nano-Silver Versus Bioactive Glass for Primary Teeth Exposed to Therapeutic Radiation
Radiation Caries
Active, not recruiting
Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.
Class V Dental Caries
Not yet recruitingObservational study
Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma
Oral Squamous Cell Carcinoma (OSCC), Periodontal Disease
Not yet recruiting
Clinical Evaluation of Self-Adhesive Flowable Giomer With and Without Selective Enamel Etching
Cervical Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing G2-Bond Universal and BeautiBond Xtreme Universal Adhesive in people with Cervical Caries, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration retention (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.