Clinical PerformancePhase 1NCT05509127
Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive
A Phase 1 study testing Modified universal adhesive and Conventional universal adhesive in people with Clinical Performance, run by Cairo University at 1 site in Egypt.
Trial summary
Class V restorations are evaluated to reveal whether the use of modified universal adhesive will have a similar performance compared to conventional universal adhesive or not. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Performance
- What is being tested?
- Modified universal adhesive and Conventional universal adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Phase 1
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Small to moderate carious cervical lesions. (ICDAS scores 3,4)
- Upper premolar teeth.
- Good oral hygiene (mild to moderate plaque accumulation)
- Vital teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and normal contact with adjacent teeth.
Who cannot join
- Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates.
- Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia.
- Evidence of parafunctional habits and TMJ disorders.
- Class V lesions in molars.
- Non-carious cervical lesions.
- Deep carious defects (close to pulp, less than 1 mm distance).
Show all 12Show fewer
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Endodontically treated teeth.
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Severe periodontal affection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive Compared to Conventional Universal Adhesive: A Randomized Clinical Trial
Class V restorations are evaluated to reveal whether the use of modified universal adhesive will have a similar performance compared to conventional universal adhesive or not.
Read the detailed description
The innovative Scotchbond Universal Plus Adhesive offers all the benefits of its predecessor, Single Bond Universal Adhesive as demonstrated by a 3M field evaluation comparing the performance of the two products. These benefits include:
- Compatibility with all etching techniques - total-etch, self-etch, and selective enamel etch.
- Usage with direct and indirect indications.
- Bonding to all dental surfaces without the need for separate primers or silanes
- Virtually no post-operative sensitivity.
The newly modified adhesive with its careful formulation offers:
- Radiopacity like dentin to reduce the risk of X-ray misdiagnosis and overtreatment.
- Ability to bond and seal caries-affected dentin to support minimally invasive preparation guidelines and maximize preservation of natural tooth structure.
- Adhesion to all dental substrates and all direct and indirect materials, including glass ceramics.
- Full dual- and self-cure compatibility without the need for an additional dual-cure activator bottle.
- A BPA derivative-free formulation to alleviate concerns about BPA in dental materials
- A fully aligned system with RelyX™ Universal Resin Cement, offering excellent bond strength for virtually all dual-cure resin cement indications.
As with any new material or technique, long-term clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. So, the aim of this study is to evaluate the clinical performance of the modified universal adhesive, versus the conventional universal adhesive, for restoring carious class V cavities over one year and a half.
- Conditions
- Clinical Performance
- Being tested
- Modified universal adhesive, Conventional universal adhesive
- Keywords
- Performance, Carious, Cervical, Universal adhesive, USPHS criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified universal adhesiveDrug
Also called 3M ESPE™ Scotchbond Universal Plus Adhesive
Application of the modified universal adhesive is done according to manufacturer's instructions using a micro-brush. It is actively rubbed for 20 seconds, gently air-dried for 5 seconds then light cured for 20 seconds.
Conventional universal adhesiveDrug
Also called 3M ESPE™ Single Bond Universal Adhesive
Application of the conventional Single Bond Universal adhesive is done using a micro-brush followed by rubbing for 20 seconds, gentle air drying for 5 seconds then light curing for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Carious cervical lesions treated with modified universal adhesive | Experimental | Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of modified universal adhesive. The cavity is then restored with nano-filled resin composite. Receives: Drug: Modified universal adhesive |
| Carious cervical lesions treated with conventional universal adhesive | Active comparator | Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of conventional universal adhesive. The cavity is then restored with nano-filled resin composite. Receives: Drug: Conventional universal adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marginal adaptation
using Modified USPHS criteria
Measured: Baseline, 6 months, 12 months, 18 months and 24 months.
Secondary outcomes (4)
Marginal discoloration
using Modified USPHS criteria
Measured: Baseline, 6 months, 12 months, 18 months and 24 months.
Post-operative sensitivity
using Modified USPHS criteria
Measured: Baseline, 6 months, 12 months, 18 months and 24 months.
Retention
using Modified USPHS criteria
Measured: Baseline, 6 months, 12 months, 18 months and 24 months.
Secondary caries
using Modified USPHS criteria
Measured: Baseline, 6 months, 12 months, 18 months and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Jan 2023
- Primary completion15 Aug 2024
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical PerformanceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Gamal Dawoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509127
- Sponsor's protocol ID
- Modified Universal Adhesive
- Status last verified
- Oct 2024
- First submitted
- 16 Aug 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dawoud B, Abou-Auf E, Shaalan O. 24-Month clinical evaluation of cervical restorations bonded using radio-opaque universal adhesive compared to conventional universal adhesive in carious cervical lesions: A randomized clinical trial. Sci Rep. 2025 Feb 14;15(1):5505. doi: 10.1038/s41598-025-88201-2.
PubMed 39952990
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive Compared to Conventional Universal Adhesive: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05509127
- Acronym / sponsor ID
- Modified Universal Adhesive
- Conditions
- Clinical Performance
- Keywords
- Performance, Carious, Cervical, Universal adhesive, USPHS criteria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 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.
Class V restorations are evaluated to reveal whether the use of modified universal adhesive will have a similar performance compared to conventional universal adhesive or not.
Detailed description
The innovative Scotchbond Universal Plus Adhesive offers all the benefits of its predecessor, Single Bond Universal Adhesive as demonstrated by a 3M field evaluation comparing the performance of the two products. These benefits include:
- Compatibility with all etching techniques - total-etch, self-etch, and selective enamel etch.
- Usage with direct and indirect indications.
- Bonding to all dental surfaces without the need for separate primers or silanes
- Virtually no post-operative sensitivity.
The newly modified adhesive with its careful formulation offers:
- Radiopacity like dentin to reduce the risk of X-ray misdiagnosis and overtreatment.
- Ability to bond and seal caries-affected dentin to support minimally invasive preparation guidelines and maximize preservation of natural tooth structure.
- Adhesion to all dental substrates and all direct and indirect materials, including glass ceramics.
- Full dual- and self-cure compatibility without the need for an additional dual-cure activator bottle.
- A BPA derivative-free formulation to alleviate concerns about BPA in dental materials
- A fully aligned system with RelyX™ Universal Resin Cement, offering excellent bond strength for virtually all dual-cure resin cement indications.
As with any new material or technique, long-term clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. So, the aim of this study is to evaluate the clinical performance of the modified universal adhesive, versus the conventional universal adhesive, for restoring carious class V cavities over one year and a half.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carious cervical lesions treated with modified universal adhesive | Experimental | Drug: Modified universal adhesivePreparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of modified universal adhesive. The cavity is then restored with nano-filled resin composite. |
| Carious cervical lesions treated with conventional universal adhesive | Active comparator | Drug: Conventional universal adhesivePreparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of conventional universal adhesive. The cavity is then restored with nano-filled resin composite. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Small to moderate carious cervical lesions. (ICDAS scores 3,4)
- Upper premolar teeth.
- Good oral hygiene (mild to moderate plaque accumulation)
- Vital teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and normal contact with adjacent teeth.
Key exclusion criteria (12 listed)
- Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates.
- Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia.
- Evidence of parafunctional habits and TMJ disorders.
- Class V lesions in molars.
- Non-carious cervical lesions.
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 |
|---|---|---|
| Modified universal adhesiveAlso: 3M ESPE™ Scotchbond Universal Plus AdhesiveApplication of the modified universal adhesive is done according to manufacturer's instructions using a micro-brush. It is actively rubbed for 20 seconds, gently air-dried for 5 seconds then light cured for 20 seconds. | Drug | Carious cervical lesions treated with modified universal adhesive |
| Conventional universal adhesiveAlso: 3M ESPE™ Single Bond Universal AdhesiveApplication of the conventional Single Bond Universal adhesive is done using a micro-brush followed by rubbing for 20 seconds, gentle air drying for 5 seconds then light curing for 20 seconds. | Drug | Carious cervical lesions treated with conventional universal adhesive |
Primary outcome
Change in Marginal adaptation
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.
using Modified USPHS criteria
4 secondary outcomes
Marginal discoloration
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.
Post-operative sensitivity
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.
Retention
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.
Secondary caries
Time frame: Baseline, 6 months, 12 months, 18 months and 24 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 16 Oct 2024.
- Derived from this study: PubMed 39952990Dawoud B, Abou-Auf E, Shaalan O. 24-Month clinical evaluation of cervical restorations bonded using radio-opaque universal adhesive compared to conventional universal adhesive in carious cervical lesions: A randomized clinical trial. Sci Rep. 2025 Feb 14;15(1):5505. doi: 10.1038/s41598-025-88201-2.
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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 Phase 1 study testing Modified universal adhesive and Conventional universal adhesive in people with Clinical Performance, 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Marginal adaptation (time frame: Baseline, 6 months, 12 months, 18 months and 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05509127, which also lists 1 linked publication.
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 16 Oct 2024.