Recurrent CariesNCT05696431
Clinical Performance of Three Universal Adhesives in Posterior Restorations
A study testing Universal adhesives application, universal adhesive with bioactive properties and Fluoride-releasing universal adhesive in people with Recurrent Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations, based on International dental federation (FDI) criteria. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Caries
- What is being tested?
- Universal adhesives application, universal adhesive with bioactive properties and Fluoride-releasing universal adhesive
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2022to 5 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients will have at least 3 posterior teeth with carious lesions of ICDAS score 4, or 5.
- The teeth will have to be vital, without spontaneous pain and/or mobility.
- Patients must have a good oral hygiene.
- Patients with normal and full occlusion.
Who cannot join
- High caries risk patients with extremely poor oral hygiene.
- Patients with abutments.
- Patients with heavy bruxism habits and clenching.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry-Mansoura university
Al Mansurah, Dakahia, 35516
Faculty of dentistry Mansoura university, 2202835
About this study
Official title: Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations
This study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations, based on International dental federation (FDI) criteria.
Read the detailed description
The description of the experimental design will follow the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study will be a double blinded (patients and examiner) randomized clinical trial anticipating the split-mouth design. 30 adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, Mansoura University will be enrolled in the current study with a total of 90 teeth with Class I or II posterior composite restorations.
No advertisement will be made for participant recruitment, forming a sample of convenience. Each patient will sign a consent form before participating in the current study. The study will be conducted from November 2022 to November 2024 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on a previous study with a similar study design. Parameters including a significance level of 5% (p < 0.05) and a power of 80% were used to calculate an appropriate sample size of 28 cases. Allowing for a 20% drop-out rate, the total sample size was set at 30 cases.
- Conditions
- Recurrent Caries
- Being tested
- Universal adhesives application, universal adhesive with bioactive properties, Fluoride-releasing universal adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal adhesives applicationOther
The adhesive will be used according to their manufacturer's instructions. Selective etching for enamel will be applied for 15 seconds, followed by rinsing and gentle air drying. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments.
universal adhesive with bioactive propertiesOther
The adhesive will be used according to their manufacturer's instructions. Enamel and dentin will be cleaned using clean and boost for 10 seconds, rinsed and gently dried. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments.
Fluoride-releasing universal adhesiveOther
Fluoride-releasing universal adhesive
| Study group | Role | What they receive |
|---|---|---|
| Universal adhesive | Placebo comparator | After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a universal adhesive as control group. Receives: Other: Universal adhesives application |
| Fluoride-releasing universal adhesive | Active comparator | After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a Fluoride-releasing universal adhesive. Receives: Other: Fluoride-releasing universal adhesive |
| Universal adhesive with bioactive properties | Active comparator | After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used.This group will receive a universal adhesive with bioactive properties. Receives: Other: universal adhesive with bioactive properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic, functional and biological properties for composite restorations
Composite restorations will be clinically assessed based on International dental federation (FDI) criteria.
Scores from 1 to 5,
- Clinically excellent
- Clinically good
- Clinically sufficient
- Clinically unsatisfactory
- Clinically poor
Measured: 2 years after restorations application
Secondary outcomes (1)
Radiographic examination
Restorative materials will be examined radiographically every 6 months.
Measured: 2 years after restorations application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start5 Nov 2022
- Primary completion5 Nov 2024 (estimated)
- Study completion5 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent CariesStudies 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
- Model description
- Each patient will receive the three universal adhesives with the same restorative material randomly in three posterior teeth. All the materials will be used according to their manufacturers' instructions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yassmine F El-Sayed, Assis.Lec, Principal investigator, Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696431
- Sponsor's protocol ID
- A01041022
- Status last verified
- Nov 2022
- First submitted
- 7 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations
- ClinicalTrials.gov ID
- NCT05696431
- Acronym / sponsor ID
- A01041022
- Conditions
- Recurrent Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 5 Nov 2024 (estimated)
- First posted
- 25 Jan 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.
This study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations, based on International dental federation (FDI) criteria.
Detailed description
The description of the experimental design will follow the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study will be a double blinded (patients and examiner) randomized clinical trial anticipating the split-mouth design. 30 adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, Mansoura University will be enrolled in the current study with a total of 90 teeth with Class I or II posterior composite restorations.
No advertisement will be made for participant recruitment, forming a sample of convenience. Each patient will sign a consent form before participating in the current study. The study will be conducted from November 2022 to November 2024 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on a previous study with a similar study design. Parameters including a significance level of 5% (p < 0.05) and a power of 80% were used to calculate an appropriate sample size of 28 cases. Allowing for a 20% drop-out rate, the total sample size was set at 30 cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Each patient will receive the three universal adhesives with the same restorative material randomly in three posterior teeth. All the materials will be used according to their manufacturers' instructions.
| Arm | Type | Receives |
|---|---|---|
| Universal adhesive | Placebo comparator | Other: Universal adhesives applicationAfter preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a universal adhesive as control group. |
| Fluoride-releasing universal adhesive | Active comparator | Other: Fluoride-releasing universal adhesiveAfter preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a Fluoride-releasing universal adhesive. |
| Universal adhesive with bioactive properties | Active comparator | Other: universal adhesive with bioactive propertiesAfter preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used.This group will receive a universal adhesive with bioactive properties. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients will have at least 3 posterior teeth with carious lesions of ICDAS score 4, or 5.
- The teeth will have to be vital, without spontaneous pain and/or mobility.
- Patients must have a good oral hygiene.
- Patients with normal and full occlusion.
Key exclusion criteria (3 listed)
- High caries risk patients with extremely poor oral hygiene.
- Patients with abutments.
- Patients with heavy bruxism habits and clenching.
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 |
|---|---|---|
| Universal adhesives applicationThe adhesive will be used according to their manufacturer's instructions. Selective etching for enamel will be applied for 15 seconds, followed by rinsing and gentle air drying. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments. | Other | Universal adhesive |
| universal adhesive with bioactive propertiesThe adhesive will be used according to their manufacturer's instructions. Enamel and dentin will be cleaned using clean and boost for 10 seconds, rinsed and gently dried. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments. | Other | Universal adhesive with bioactive properties |
| Fluoride-releasing universal adhesiveFluoride-releasing universal adhesive | Other | Fluoride-releasing universal adhesive |
Primary outcome
Aesthetic, functional and biological properties for composite restorations
Time frame: 2 years after restorations application
Composite restorations will be clinically assessed based on International dental federation (FDI) criteria. Scores from 1 to 5, 1. Clinically excellent 2. Clinically good 3. Clinically sufficient 4. Clinically unsatisfactory 5. Clinically poor
1 secondary outcome
Radiographic examination
Time frame: 2 years after restorations application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: Yes
Related trials for Recurrent Caries
Not yet recruiting
The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: A Randomized Clinical Trial
DME, Dental Caries
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.
Yassmine F El-Sayed, Assis.Lec principal investigator
Faculty of Dentistry, Mansoura 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 Universal adhesives application, universal adhesive with bioactive properties and Fluoride-releasing universal adhesive in people with Recurrent Caries, 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 4 inclusion and 3 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 Jan 2023. 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. Some participants in this study may receive a placebo. 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?
Contact Yassmine F El-Sayed, Assis.Lec (01004855670, yassmine@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aesthetic, functional and biological properties for composite restorations (time frame: 2 years after restorations application). 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 Jan 2023.