Caries; DentinNCT06058026
Clinical Comparison of Composite Materials
An observational study of Caries; Dentin, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Universal adhesive solutions have just entered the market, allowing dentists to choose an adhesive strategy based on the needs of patients and clinical situations. Theses adhesives contain a primer/adhesive resin mix in a single bottle for multi-mode etch-and-rinse or self-etch applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caries; Dentin
- What is being tested?
- World Dental Federation criteria (FDI)
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2020to 17 Sep 2022
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Teeth with primary caries, including at least one-third of the dentin (MO or DO), were included in the study.
Who may be able to join
- Individuals without systemic disease
- Individuals with good oral hygiene
- Must be a minimum of one carious defect
- Must be at least 18 years old
- Must have vital teeth in antagonist and proximal contact.
Who cannot join
- Pregnant or breastfeeding women
- Receiving orthodontic treatment
- Bruxism habit
- Direct or indirect pulp coverage
- Allergy to resin-based products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Composite Resins in Class II Cavities
Universal adhesive solutions have just entered the market, allowing dentists to choose an adhesive strategy based on the needs of patients and clinical situations. Theses adhesives contain a primer/adhesive resin mix in a single bottle for multi-mode etch-and-rinse or self-etch applications. The aim of this study was to evaluate the clinical performance of composite resins with diffent adesive agents on Class II cavities.
Read the detailed description
This study was a double-blind (evaluator and patient) randomized controlled clinical study with six study groups with an equal allocation. Two composite materials with two universal and one two-step self-etch adhesives were compared in Class II restorations.
The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of esthetic property, marginal discoloration; in terms of function properties, fracture and retention, and marginal adaptation; in terms of the biological characteristics, post-operative sensitivity, and secondary caries criteria were examined.
Clinical evaluation was performed by two qualified clinicians. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries.
Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using the Friedman test (p < 0.05).
- Conditions
- Caries; Dentin
- Being tested
- World Dental Federation criteria (FDI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
World Dental Federation criteria (FDI)Other
Restorations were evaluated with FDI criteria.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of class II restorative materials restored with different adhesives
Restored teeth were evaluated according to FDI criteria.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start31 Dec 2020
- Primary completion15 Sep 2021
- Study completion17 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; DentinStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Karadaş, Recep Tayyip Erdogan University
- Investigators
- Muhammet Karadaş, PhD, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058026
- Sponsor's protocol ID
- RTEUDHFMKARADAS001
- Status last verified
- Feb 2024
- First submitted
- 21 Sep 2023
- Last updated
- 23 Apr 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Composite Resins in Class II Cavities
- ClinicalTrials.gov ID
- NCT06058026
- Acronym / sponsor ID
- RTEUDHFMKARADAS001
- Conditions
- Caries; Dentin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 17 Sep 2022 (actual)
- First posted
- 28 Sep 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.
Universal adhesive solutions have just entered the market, allowing dentists to choose an adhesive strategy based on the needs of patients and clinical situations. Theses adhesives contain a primer/adhesive resin mix in a single bottle for multi-mode etch-and-rinse or self-etch applications. The aim of this study was to evaluate the clinical performance of composite resins with diffent adesive agents on Class II cavities.
Detailed description
This study was a double-blind (evaluator and patient) randomized controlled clinical study with six study groups with an equal allocation. Two composite materials with two universal and one two-step self-etch adhesives were compared in Class II restorations.
The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of esthetic property, marginal discoloration; in terms of function properties, fracture and retention, and marginal adaptation; in terms of the biological characteristics, post-operative sensitivity, and secondary caries criteria were examined.
Clinical evaluation was performed by two qualified clinicians. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries.
Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using the Friedman test (p < 0.05).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Teeth with primary caries, including at least one-third of the dentin (MO or DO), were included in the study.
Key inclusion criteria (5 listed)
- Individuals without systemic disease
- Individuals with good oral hygiene
- Must be a minimum of one carious defect
- Must be at least 18 years old
- Must have vital teeth in antagonist and proximal contact.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Receiving orthodontic treatment
- Bruxism habit
- Direct or indirect pulp coverage
- Allergy to resin-based products
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 |
|---|---|---|
| World Dental Federation criteria (FDI)Restorations were evaluated with FDI criteria. | Other | – |
Primary outcome
Evaluation of class II restorative materials restored with different adhesives
Time frame: Baseline
Restored teeth were evaluated according to FDI criteria.
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 23 Apr 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.
Muhammet Karadaş, PhD principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries; Dentin, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 23 Apr 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 Turkey (Türkiye). 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?
Evaluation of class II restorative materials restored with different adhesives (time frame: Baseline). 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 23 Apr 2024.