Class II Dental CariesNCT05907928
Radiographic Evaluation of Adaptation of Universal Adhesives
A study testing Scotchbond universal adhesive plus and Single bond Universal in people with Class II Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Class 2 restorations are analyzed to see whether or not the use of modified universal adhesive will result in similar adaptation to conventional universal adhesive. Read more about this study
- Who is it for?
- Ages 19 to 30 years
- Conditions the study is for
- Class II Dental Caries
- What is being tested?
- Scotchbond universal adhesive plus and Single bond Universal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 31 May 2025
- 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 19 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Small to moderate carious proximal lesions. (International caries detection and assessment system (ICDAS) scores 3,4)
- 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 tempromandibular joint disorders.
- Deep carious defects (close to pulp, less than 1 mm distance).
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
- Endodontically treated teeth.
Show all 10Show fewer
- 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: Radiographic Evaluation of Adaptation of New Radio-opaque Universal Adhesive Compared to Universal Adhesive in Proximal Restorations: Randomized Clinical Trial
Class 2 restorations are analyzed to see whether or not the use of modified universal adhesive will result in similar adaptation to conventional universal adhesive.
Read the detailed description
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 bisphenol 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, clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. Therefore, the aim of the current study was to evaluate adaptation of class 2 restorations either using radio-opaque universal adhesive or universal adhesive using digital radiography.
- Conditions
- Class II Dental Caries
- Being tested
- Scotchbond universal adhesive plus, Single bond Universal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scotchbond universal adhesive plusOther
New generation BPA free universal adhesive
Single bond UniversalOther
Also called Scotchbond universal adhesive
Radiolucent universal adhesive
| Study group | Role | What they receive |
|---|---|---|
| Radio-opaque universal adhesive | Experimental | Radio-opaque universal adhesive Receives: Other: Scotchbond universal adhesive plus |
| Conventional universal adhesive | Active comparator | Conventional universal adhesive Receives: Other: Single bond Universal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Assessment of adaptation of restoration
Modified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Apr 2025
- Primary completion1 May 2025
- Study completion31 May 2025
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 Class II Dental 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Osama Shaalan, Cairo University
- Investigators
- Omar Shaalan, PhD, Principal investigator, Lecturer, Department of Conservative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907928
- Sponsor's protocol ID
- Universal adhesive plus
- Status last verified
- May 2025
- First submitted
- 7 Jun 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaalan O, Kamal D. Radiographic appearance of proximal resin composite restorations bonded with a radiopaque or radiolucent universal adhesive: a randomized clinical trial. BDJ Open. 2026 Nov 3;12(1):105. doi: 10.1038/s41405-026-00494-1.
PubMed 42977742
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of Adaptation of New Radio-opaque Universal Adhesive Compared to Universal Adhesive in Proximal Restorations: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05907928
- Acronym / sponsor ID
- Universal adhesive plus
- Conditions
- Class II Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 18 Jun 2023 (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 2 restorations are analyzed to see whether or not the use of modified universal adhesive will result in similar adaptation to conventional universal adhesive.
Detailed description
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 bisphenol 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, clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. Therefore, the aim of the current study was to evaluate adaptation of class 2 restorations either using radio-opaque universal adhesive or universal adhesive using digital radiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radio-opaque universal adhesive | Experimental | Other: Scotchbond universal adhesive plusRadio-opaque universal adhesive |
| Conventional universal adhesive | Active comparator | Other: Single bond UniversalConventional universal adhesive |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Small to moderate carious proximal lesions. (International caries detection and assessment system (ICDAS) scores 3,4)
- 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 (10 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 tempromandibular joint disorders.
- Deep carious defects (close to pulp, less than 1 mm distance).
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
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 |
|---|---|---|
| Scotchbond universal adhesive plusNew generation BPA free universal adhesive | Other | Radio-opaque universal adhesive |
| Single bond UniversalAlso: Scotchbond universal adhesiveRadiolucent universal adhesive | Other | Conventional universal adhesive |
Primary outcome
Radiographic Assessment of adaptation of restoration
Time frame: 1week
Modified USPHS criteria: Score A : harmonious transition between restoration and tooth; Score B: Presence of adhesive line (Radiolucent zone) below the restoration
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 30 Sep 2026.
- Derived from this study: PubMed 42977742Shaalan O, Kamal D. Radiographic appearance of proximal resin composite restorations bonded with a radiopaque or radiolucent universal adhesive: a randomized clinical trial. BDJ Open. 2026 Nov 3;12(1):105. doi: 10.1038/s41405-026-00494-1.
- Individual participant dataSharing planned: No
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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.
Omar Shaalan, PhD principal investigator
Lecturer, Department of Conservative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scotchbond universal adhesive plus and Single bond Universal in people with Class II Dental Caries, 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 4 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: finished, as of the sponsor's last update on 30 Sep 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?
Radiographic Assessment of adaptation of restoration (time frame: 1week). 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 NCT05907928, 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 30 Sep 2026.