Dental CariesNCT06612021
Hema Free Versus Hema Containing Adhesives in Posterior Restorations
A study testing Beautibond universal adhesive and Tetric N universal bond in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Beautibond universal adhesive and Tetric N universal bond
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2023to 1 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with occlusal caries in molars classified as ICDAS III or IV.
- 19-35 years.
- Males or Females.
- Co-operative patients approving to participate in the trial.
Who cannot join
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
- Rampant caries.
- Heavy smoking.
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- Xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or tempromandibular joint disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Posterior Restorations Using Hema Free Universal Adhesive Versus Hema Containing Universal Adhesive Over One Year Using USPHS Criteria: Randomized Controlled Trial
The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.
Read the detailed description
The study is intended to evaluate the HEMA free universal adhesive versus HEMA containing universal adhesive when both used in conjunction with giomer aesthetic restorations in occlusal cavities in posterior teeth ICDAS III and IV.
The restorations will be evaluated at baseline, 6 and 12 months according to modified USPHS criteria in terms of marginal staining, marginal adaptation and caries recurrence.
Patients will be recruited from outpatient clinic of conservative dentistry department, cairo university according to inclusion and exclusion criteria. patient will be randomly allocated to intervention or control group.
- Conditions
- Dental Caries
- Being tested
- Beautibond universal adhesive, Tetric N universal bond
- Keywords
- HEMA free, HEMA containing adhesive, Giomers, Giomer, USPHS criteria
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beautibond universal adhesiveProcedure or surgery
HEMA free universal adhesive
Tetric N universal bondProcedure or surgery
HEMA containing universal bond
| Study group | Role | What they receive |
|---|---|---|
| HEMA free universal adhesive group | Experimental | Not described Receives: Procedure: Beautibond universal adhesive |
| HEMA containing universal adhesive group | Active comparator | Not described Receives: Procedure: Tetric N universal bond |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal staining of restoration
marginal staining using USPHS criteria Alpha: No staining in the margin Bravo: superficial staining on the margin Charlie: deep staining on the margin
Measured: baseline ,6 months & 12 months
Secondary outcomes (2)
caries recurrence
caries recurrence using USPHS criteria Alpha: no recurrent caries Charlie: Caries recurrence
Measured: baseline ,6 months ,12 months
marginal adaptation of restoration
marginal adaptation using USPHS criteria ALPHA: Marginal continuity BRAVO: slightly detectable marginal discontinuity that does not require replacement CHARLIE: Detectable crevice or ledge at margin that requires replacement
Measured: baseline ,6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start14 Jul 2023
- Primary completion14 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fathi Abdelsalam, Cairo University
- Investigators
- Alaa F Abdelsalam, phD, Principal investigator, lecturer of conservative dentistry, Cairo universityHadier M Gad, PhD, Principal investigator, Lecturer of conservative dentistry, Cairo universityManar A Elmokanen, PhD, Principal investigator, Lecturer of conservative dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612021
- Sponsor's protocol ID
- 2255874
- Status last verified
- Sep 2024
- First submitted
- 25 Aug 2023
- Last updated
- 25 Sep 2024
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Posterior Restorations Using Hema Free Universal Adhesive Versus Hema Containing Universal Adhesive Over One Year Using USPHS Criteria: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06612021
- Acronym / sponsor ID
- 2255874
- Conditions
- Dental Caries
- Keywords
- HEMA free, HEMA containing adhesive, Giomers, Giomer, USPHS criteria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 14 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 25 Sep 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.
The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.
Detailed description
The study is intended to evaluate the HEMA free universal adhesive versus HEMA containing universal adhesive when both used in conjunction with giomer aesthetic restorations in occlusal cavities in posterior teeth ICDAS III and IV.
The restorations will be evaluated at baseline, 6 and 12 months according to modified USPHS criteria in terms of marginal staining, marginal adaptation and caries recurrence.
Patients will be recruited from outpatient clinic of conservative dentistry department, cairo university according to inclusion and exclusion criteria. patient will be randomly allocated to intervention or control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEMA free universal adhesive group | Experimental | Procedure: Beautibond universal adhesive |
| HEMA containing universal adhesive group | Active comparator | Procedure: Tetric N universal bond |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with occlusal caries in molars classified as ICDAS III or IV.
- 19-35 years.
- Males or Females.
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (9 listed)
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
- Rampant caries.
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 |
|---|---|---|
| Beautibond universal adhesiveHEMA free universal adhesive | Procedure or surgery | HEMA free universal adhesive group |
| Tetric N universal bondHEMA containing universal bond | Procedure or surgery | HEMA containing universal adhesive group |
Primary outcome
marginal staining of restoration
Time frame: baseline ,6 months & 12 months
marginal staining using USPHS criteria Alpha: No staining in the margin Bravo: superficial staining on the margin Charlie: deep staining on the margin
2 secondary outcomes
caries recurrence
Time frame: baseline ,6 months ,12 months
marginal adaptation of restoration
Time frame: baseline ,6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- 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.
Alaa F Abdelsalam, phD principal investigator
lecturer of conservative dentistry, Cairo university
Hadier M Gad, PhD principal investigator
Lecturer of conservative dentistry, Cairo university
Manar A Elmokanen, PhD principal investigator
Lecturer of conservative dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beautibond universal adhesive and Tetric N universal bond in people with 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 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: status not confirmed, as of the sponsor's last update on 25 Sep 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.
Are results available for this study?
Results are not available in the source record.
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?
marginal staining of restoration (time frame: baseline ,6 months & 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 25 Sep 2024.