Dental Caries Class IINCT06265116
One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations
A study testing One-step universal adhesive in people with Dental Caries Class II and Marginal Integrity of Composite Restorations With Universal Adhesives, run by Mansoura University at 1 site in Egypt.
Trial summary
to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class II, Marginal Integrity of Composite Restorations With Universal Adhesives
- What is being tested?
- One-step universal adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2024to 30 Jan 2027
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must present with at least four posterior primary compound proximal caries involving two surfaces, specifically occluso-mesial or occluso-distal cavities, with a corresponding International Caries Detection and Assessment System (ICDAS) score of 4 or 5.
- The buccolingual width of the lesion should be approximately less than two-thirds of the intercuspal distance.
- Teeth to be restored must be in normal occlusion with the natural antagonist teeth.
- Vital teeth with no signs of pulpal inflammation or pathological lesions.
- Normal periodontal status and good oral hygiene.
- Good likelihood of recall availability.
Who cannot join
- Patients with proximal cavities that extend beyond two surfaces or have a lesion buccolingual width greater than two-thirds of the intercuspal distance, or requiring cusp coverage.
- Partly erupted or endodontic treated teeth.
- Poor oral hygiene or severe periodontitis.
- Absence of neighboring or antagonist teeth.
- Patients with known allergy to any component of the study materials.
- Patients with unstable medical conditions.
Show all 9Show fewer
- Patients with known unavailability to attend recall visits.
- Pregnant or lactating females.
- Patients with heavy para-functional habits, fractured, or visibly cracked teeth.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Omar Abd El-Fattah Abd El-Maksoud
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: One-Step Universal Adhesives: A 3-year Randomized Comparative Clinical Trial in Class II Composite Restorations
to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period.
Read the detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split-mouth design. A total of forty-eight adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.
No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation
- Conditions
- Dental Caries Class II, Marginal Integrity of Composite Restorations With Universal Adhesives
- Being tested
- One-step universal adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-step universal adhesiveOther
Each patient will receive a class II restoration using the corresponding group adhesive
| Study group | Role | What they receive |
|---|---|---|
| Bis-GMA-containing, HEMA-containing, one-step universal adhesive. | Active comparator | Each patient will randomly receive one class II restoration with one of the tested restorative systems Receives: Other: One-step universal adhesive |
| Bis-GMA-free, HEMA-containing, one-step universal adhesive | Active comparator | Each patient will randomly receive one class II restoration with one of the tested restorative systems Receives: Other: One-step universal adhesive |
| Bis-GMA- free, HEMA-free, acrylic-based one-step universal adhesive | Active comparator | Each patient will randomly receive one class II restoration with one of the tested restorative systems Receives: Other: One-step universal adhesive |
| Bis-GMA- containing, HEMA-containing, amide-based one-step universal adhesive | Active comparator | Each patient will randomly receive one class II restoration with one of the tested restorative systems Receives: Other: One-step universal adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of functional and biological properties for each group
Percentage of functional and biological properties that will be clinically assessed using recently revised World Dental Federation parameters for each restorative system group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start23 Jan 2024
- Primary completion23 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Class IIStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Abd El-fattah, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265116
- Sponsor's protocol ID
- A0801024 CD
- Status last verified
- May 2025
- First submitted
- 6 Feb 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Step Universal Adhesives: A 3-year Randomized Comparative Clinical Trial in Class II Composite Restorations
- ClinicalTrials.gov ID
- NCT06265116
- Acronym / sponsor ID
- A0801024 CD
- Conditions
- Dental Caries Class II, Marginal Integrity of Composite Restorations With Universal Adhesives
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 23 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 20 Feb 2024 (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.
to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period.
Detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split-mouth design. A total of forty-eight adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.
No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bis-GMA-containing, HEMA-containing, one-step universal adhesive. | Active comparator | Other: One-step universal adhesiveEach patient will randomly receive one class II restoration with one of the tested restorative systems |
| Bis-GMA-free, HEMA-containing, one-step universal adhesive | Active comparator | Other: One-step universal adhesiveEach patient will randomly receive one class II restoration with one of the tested restorative systems |
| Bis-GMA- free, HEMA-free, acrylic-based one-step universal adhesive | Active comparator | Other: One-step universal adhesiveEach patient will randomly receive one class II restoration with one of the tested restorative systems |
| Bis-GMA- containing, HEMA-containing, amide-based one-step universal adhesive | Active comparator | Other: One-step universal adhesiveEach patient will randomly receive one class II restoration with one of the tested restorative systems |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients must present with at least four posterior primary compound proximal caries involving two surfaces, specifically occluso-mesial or occluso-distal cavities, with a corresponding International Caries Detection and Assessment System (ICDAS) score of 4 or 5.
- The buccolingual width of the lesion should be approximately less than two-thirds of the intercuspal distance.
- Teeth to be restored must be in normal occlusion with the natural antagonist teeth.
- Vital teeth with no signs of pulpal inflammation or pathological lesions.
- Normal periodontal status and good oral hygiene.
Key exclusion criteria (9 listed)
- Patients with proximal cavities that extend beyond two surfaces or have a lesion buccolingual width greater than two-thirds of the intercuspal distance, or requiring cusp coverage.
- Partly erupted or endodontic treated teeth.
- Poor oral hygiene or severe periodontitis.
- Absence of neighboring or antagonist teeth.
- Patients with known allergy to any component of the study materials.
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 |
|---|---|---|
| One-step universal adhesiveEach patient will receive a class II restoration using the corresponding group adhesive | Other | Bis-GMA- containing, HEMA-containing, amide-based one-step universal adhesive, Bis-GMA- free, HEMA-free, acrylic-based one-step universal adhesive, Bis-GMA-containing, HEMA-containing, one-step universal adhesive., Bis-GMA-free, HEMA-containing, one-step universal adhesive |
Primary outcome
Percentage of functional and biological properties for each group
Time frame: 3 years
Percentage of functional and biological properties that will be clinically assessed using recently revised World Dental Federation parameters for each restorative system group
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 May 2025.
- 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.
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 One-step universal adhesive in people with Dental Caries Class II and Marginal Integrity of Composite Restorations With Universal Adhesives, run by Mansoura 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 9 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 8 May 2025. 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?
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?
Percentage of functional and biological properties for each group (time frame: 3 years). 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 May 2025.