Universal AdhesiveNCT05497583
HEMA-free Universal Adhesives for Restoring Non-carious Cervical Lesions
A study testing Acetone based HEMA -free universal Adhesive and Isopropanol based HEMA- free universal Adhesive in people with Universal Adhesive, run by Cairo University at 1 site in Egypt.
Trial summary
because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important since the stability of the bond between the adhesive and substrates is related to the clinical success… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Universal Adhesive
- What is being tested?
- Acetone based HEMA -free universal Adhesive and Isopropanol based HEMA- free universal Adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 23 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants had to be in good general health, be at least 18 years old
- have an acceptable oral hygiene level
- Participants were required to have NCCLs in different teeth preferably anterior or posterior that needed to be restored.
- These lesions had to be noncarious
- deeper than 1 mm
- involve both the enamel and dentin of vital teeth without mobility.
Who cannot join
- Uncooperative behavior, limits the use of adhesive due to hampering of adequate field or isolation techniques throughout the procedure.
- Patients allergic to the adhesive material. Patients with extremely poor oral hygiene
- severe or chronic periodontitis
- heavy bruxism habits
- Pulp involvement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Acetone Based HEMA-Free Universal Adhesive Versus Isopropanol Based HEMA-Free Universal Adhesive For Restoring Non-Carious Cervical Lesions Over A Period Of 18-Months Follow Up Using FDI Criteria: A Randomized Controlled Trial
because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important since the stability of the bond between the adhesive and substrates is related to the clinical success of restorations. Because significant hydrolysis of the dentin-resin interface occurs after 6-12 months, a clinical trial of at least 18 months' duration is indicated to more accurately depict the likelihood of long-term clinical success
Read the detailed description
Cervical restorations are ever challenging because of difficulties in moisture control, caries access, and proximity to the gingival margin. Both mechanical and non-mechanical factors act to hinder the longevity of cervical restoration newer materials are readily introduced in the market with improved chemomechanical properties, longevity, patient safety, and comfort.
The introduction of new-generation adhesive systems has aimed at reducing technique sensitivity and the number of clinical steps required for adhesion. There has been a trend toward the use of less time-consuming options, continuing this trend, universal adhesives have recently been introduced to the profession. However, because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important since the stability of the bond between the adhesive and substrates is related to the clinical success of restorations. Although the most reliable conclusions about the performance of adhesives in the oral environment are derived from clinical trials.
To evaluate the effectiveness and clinical performance of adhesive systems, the American Dental Association (ADA) recommends clinical trials on non-carious cervical lesions (NCCLs), as composite resin restorations only remain bonded to these lesions by the micromechanical interlocking produced by the adhesive systems. The immediate, short-term, and long-term bonding performance of adhesive systems are then evaluated by retention, marginal integrity, and marginal discoloration. There are many attempts to improve bonding to substrates, bond strength, and bond durability, one of these attempts is the newly introduced universal adhesive (BeautiBond ).
- Conditions
- Universal Adhesive
- Being tested
- Acetone based HEMA -free universal Adhesive, Isopropanol based HEMA- free universal Adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetone based HEMA -free universal AdhesiveOther
Teeth that meet the inclusion criteria will be selected. the operator will prepare incisal bevel. Rubber dam isolation will be used .apply etchant (phosphoric acid etching gel 37 %) only on enamel for 15 s Rinse, for 10 s Air dry to remove excess water then will apply Universal adhesive to the entire bonding surface according to manufacture instructions. Bioactive composite ( beautifill II ) will be used.
Isopropanol based HEMA- free universal AdhesiveOther
Teeth that meet the inclusion criteria will be selected. the operator will prepare incisal bevel. Rubber dam isolation will be used .apply etchant (phosphoric acid etching gel 37 %) only on enamel for 15 s Rinse, for 10 s Air dry to remove excess water then will apply Universal adhesive to the entire bonding surface according to manufacture instructions. resin composite (Neo Spectra™ ST) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Acetone based HEMA free Universal Adhesive | Experimental | Patients with non-carious cervical lesions will be treated with Acetone Based HEMA-free Universal Adhesive (BeautiBond universal adhesive ) applied in a self-etch approach with (SE) selective enamel etching. Receives: Other: Acetone based HEMA -free universal Adhesive |
| Isopropanol based HEMA-free universal Adhesive | Active comparator | Patients with non-carious cervical lesions will be treated with isopropanol-based HEMA-free universal Adhesive (Prime\&Bond universal™ Adhesive system) applied in a self-etch approach with (SE) selective enamel etching. Receives: Other: Isopropanol based HEMA- free universal Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome (marginal staining)
FDI (World Dental Federation)criteria
Measured: 18 months
Secondary outcomes (1)
Retention, marginal adaptation, Postoperative (Hyper-Sensitivity), and Recurrence of Caries
FDI (World Dental Federation)criteria
Measured: T0=Baseline immediate postoperative T1= 6 months follow up. T2=12 months follow up. T3=18 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start15 Jan 2023
- Primary completion20 Sep 2024
- Study completion23 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Universal AdhesiveStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Shawky Ramadan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497583
- Sponsor's protocol ID
- universal adhesive
- Status last verified
- Mar 2026
- First submitted
- 6 Aug 2022
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Acetone Based HEMA-Free Universal Adhesive Versus Isopropanol Based HEMA-Free Universal Adhesive For Restoring Non-Carious Cervical Lesions Over A Period Of 18-Months Follow Up Using FDI Criteria: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05497583
- Acronym / sponsor ID
- universal adhesive
- Conditions
- Universal Adhesive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 11 Aug 2022 (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.
because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important since the stability of the bond between the adhesive and substrates is related to the clinical success of restorations. Because significant hydrolysis of the dentin-resin interface occurs after 6-12 months, a clinical trial of at least 18 months' duration is indicated to more accurately depict the likelihood of long-term clinical success
Detailed description
Cervical restorations are ever challenging because of difficulties in moisture control, caries access, and proximity to the gingival margin. Both mechanical and non-mechanical factors act to hinder the longevity of cervical restoration newer materials are readily introduced in the market with improved chemomechanical properties, longevity, patient safety, and comfort.
The introduction of new-generation adhesive systems has aimed at reducing technique sensitivity and the number of clinical steps required for adhesion. There has been a trend toward the use of less time-consuming options, continuing this trend, universal adhesives have recently been introduced to the profession. However, because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important since the stability of the bond between the adhesive and substrates is related to the clinical success of restorations. Although the most reliable conclusions about the performance of adhesives in the oral environment are derived from clinical trials.
To evaluate the effectiveness and clinical performance of adhesive systems, the American Dental Association (ADA) recommends clinical trials on non-carious cervical lesions (NCCLs), as composite resin restorations only remain bonded to these lesions by the micromechanical interlocking produced by the adhesive systems. The immediate, short-term, and long-term bonding performance of adhesive systems are then evaluated by retention, marginal integrity, and marginal discoloration. There are many attempts to improve bonding to substrates, bond strength, and bond durability, one of these attempts is the newly introduced universal adhesive (BeautiBond ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetone based HEMA free Universal Adhesive | Experimental | Other: Acetone based HEMA -free universal AdhesivePatients with non-carious cervical lesions will be treated with Acetone Based HEMA-free Universal Adhesive (BeautiBond universal adhesive ) applied in a self-etch approach with (SE) selective enamel etching. |
| Isopropanol based HEMA-free universal Adhesive | Active comparator | Other: Isopropanol based HEMA- free universal AdhesivePatients with non-carious cervical lesions will be treated with isopropanol-based HEMA-free universal Adhesive (Prime\&Bond universal™ Adhesive system) applied in a self-etch approach with (SE) selective enamel etching. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants had to be in good general health, be at least 18 years old
- have an acceptable oral hygiene level
- Participants were required to have NCCLs in different teeth preferably anterior or posterior that needed to be restored.
- These lesions had to be noncarious
- deeper than 1 mm
Key exclusion criteria (5 listed)
- Uncooperative behavior, limits the use of adhesive due to hampering of adequate field or isolation techniques throughout the procedure.
- Patients allergic to the adhesive material. Patients with extremely poor oral hygiene
- severe or chronic periodontitis
- heavy bruxism habits
- Pulp involvement
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 |
|---|---|---|
| Acetone based HEMA -free universal AdhesiveTeeth that meet the inclusion criteria will be selected. the operator will prepare incisal bevel. Rubber dam isolation will be used .apply etchant (phosphoric acid etching gel 37 %) only on enamel for 15 s Rinse, for 10 s Air dry to remove excess water then will apply Universal adhesive to the entire bonding surface according to manufacture instructions. Bioactive composite ( beautifill II ) will be used. | Other | Acetone based HEMA free Universal Adhesive |
| Isopropanol based HEMA- free universal AdhesiveTeeth that meet the inclusion criteria will be selected. the operator will prepare incisal bevel. Rubber dam isolation will be used .apply etchant (phosphoric acid etching gel 37 %) only on enamel for 15 s Rinse, for 10 s Air dry to remove excess water then will apply Universal adhesive to the entire bonding surface according to manufacture instructions. resin composite (Neo Spectra™ ST) will be used. | Other | Isopropanol based HEMA-free universal Adhesive |
Primary outcome
Primary outcome (marginal staining)
Time frame: 18 months
FDI (World Dental Federation)criteria
1 secondary outcome
Retention, marginal adaptation, Postoperative (Hyper-Sensitivity), and Recurrence of Caries
Time frame: T0=Baseline immediate postoperative T1= 6 months follow up. T2=12 months follow up. T3=18 months follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
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Clinical Performance of Two HEMA-Free Universal Adhesive Systems
Cervical Caries
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Effect on Placement Tecnique of Bulkfill Composite
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Healthy Participant
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetone based HEMA -free universal Adhesive and Isopropanol based HEMA- free universal Adhesive in people with Universal Adhesive, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome (marginal staining) (time frame: 18 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 9 Mar 2026.