Dental Adhesive MaterialsNCT04589416
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems
A study testing Dental adhesive materials. in people with Dental Adhesive Materials, run by Nuh Naci Yazgan University.
Trial summary
Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch \& rinse (ER) and self-etch (SE) systems have been used for many years. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Adhesive Materials
- What is being tested?
- Dental adhesive materials.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 Apr 2018
- 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 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 3 Class-I caries lesions
- Good health
- Acceptable level of oral hygiene
Who cannot join
- Did not have four caries lesions at least
- Did not have Class-II caries lesions
- Deep caries reaching the pulp
- The patients are not 18-22 years old
- Bruxism
- Periodontal disease
- Refused to participate
About this study
Official title: Erciyes University Clinical Research Ethics Committee
Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch \& rinse (ER) and self-etch (SE) systems have been used for many years. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).
Read the detailed description
Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch \& rinse (ER) and self-etch (SE) systems have been used for many years. Compared to SE systems, which are simplified and very easy to use, requiring less technical precision, traditional ER systems are still very popular and preferred by dentists. However, current researchers indicate that ER systems are more effective on enamel than dentin and that this effect is better than SE systems. SE systems are approaches in which the acid application and washing step are eliminated clinically and the possibility of making mistakes during the application and manipulation is reduced. An important advantage of these systems is that demineralization and resin infiltration occurs at the same time. Clinically, the application times are shorter than traditional systems. Two-steps SE systems have been used for a long time. In this system, the need for a separate acidic primer application has needed clinicians reason to search for single-steps bonding agents. And, in recent years, single-step SE systems also called "all in one", have been developed that include all steps of pickling, primer application, and adhesive agent application. However, there are studies showing that these systems do not perform as well as two-step SE systems. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).
- Conditions
- Dental Adhesive Materials
- Being tested
- Dental adhesive materials.
- Keywords
- Adhesive system, Clinical follow-up, Class I restoration, Composite resin, FDI, USPHS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental adhesive materials.Other
It is used to bond the composite resin to the dental tissues. That is, it is used to bond dental filling materials to dental tissues.
| Study group | Role | What they receive |
|---|---|---|
| Single Bond 2 | Active comparator | Single Bond 2 is a traditional etch and rinse adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions. Receives: Other: Dental adhesive materials. |
| Clearfil SE Bond | Active comparator | Clearfil SE bond is traditional two step self-etch adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions. Receives: Other: Dental adhesive materials. |
| Tri-S Bond | Active comparator | Tri-S bond is traditional one step self-etch adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions. Receives: Other: Dental adhesive materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria
FDI; World Dental Federation USPHS; United States Public Health Service. Two calibrated observers who were blinded to the objective of this study performed the evaluations.
Measured: One years
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria
FDI; World Dental Federation USPHS; United States Public Health Service. Two calibrated observers who were blinded to the objective of this study performed the evaluations.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Feb 2016
- Primary completion1 Feb 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Adhesive MaterialsStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazire Nurdan Çakır, Nuh Naci Yazgan University
- Investigators
- Nazire Nurdan Çakır, Principal investigator, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589416
- Sponsor's protocol ID
- 5930
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erciyes University Clinical Research Ethics Committee
- ClinicalTrials.gov ID
- NCT04589416
- Acronym / sponsor ID
- 5930
- Conditions
- Dental Adhesive Materials
- Keywords
- Adhesive system, Clinical follow-up, Class I restoration, Composite resin, FDI, USPHS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Nuh Naci Yazgan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 19 Oct 2020 (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.
Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch \& rinse (ER) and self-etch (SE) systems have been used for many years. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).
Detailed description
Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch \& rinse (ER) and self-etch (SE) systems have been used for many years. Compared to SE systems, which are simplified and very easy to use, requiring less technical precision, traditional ER systems are still very popular and preferred by dentists. However, current researchers indicate that ER systems are more effective on enamel than dentin and that this effect is better than SE systems. SE systems are approaches in which the acid application and washing step are eliminated clinically and the possibility of making mistakes during the application and manipulation is reduced. An important advantage of these systems is that demineralization and resin infiltration occurs at the same time. Clinically, the application times are shorter than traditional systems. Two-steps SE systems have been used for a long time. In this system, the need for a separate acidic primer application has needed clinicians reason to search for single-steps bonding agents. And, in recent years, single-step SE systems also called "all in one", have been developed that include all steps of pickling, primer application, and adhesive agent application. However, there are studies showing that these systems do not perform as well as two-step SE systems. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Bond 2 | Active comparator | Other: Dental adhesive materials.Single Bond 2 is a traditional etch and rinse adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions. |
| Clearfil SE Bond | Active comparator | Other: Dental adhesive materials.Clearfil SE bond is traditional two step self-etch adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions. |
| Tri-S Bond | Active comparator | Other: Dental adhesive materials.Tri-S bond is traditional one step self-etch adhesive system. It is used to bond the composite resin to the dental tissues. It was applied to the cavities opened in accordance with the manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least 3 Class-I caries lesions
- Good health
- Acceptable level of oral hygiene
Key exclusion criteria (7 listed)
- Did not have four caries lesions at least
- Did not have Class-II caries lesions
- Deep caries reaching the pulp
- The patients are not 18-22 years old
- Bruxism
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 |
|---|---|---|
| Dental adhesive materials.It is used to bond the composite resin to the dental tissues. That is, it is used to bond dental filling materials to dental tissues. | Other | Clearfil SE Bond, Single Bond 2, Tri-S Bond |
Primary outcome
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria
Time frame: One years
FDI; World Dental Federation USPHS; United States Public Health Service. Two calibrated observers who were blinded to the objective of this study performed the evaluations.
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria
Time frame: Two years
FDI; World Dental Federation USPHS; United States Public Health Service. Two calibrated observers who were blinded to the objective of this study performed the evaluations.
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 19 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Nazire Nurdan Çakır principal investigator
Nuh Naci Yazgan University
Questions about this trial
What is this clinical trial studying?
A study testing Dental adhesive materials. in people with Dental Adhesive Materials, run by Nuh Naci Yazgan University.
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 3 inclusion and 7 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems with FDI and USPHS criteria (time frame: One years). The study lists 2 primary outcomes in all. 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 19 Oct 2020.