Caries; DentinNCT06109987
Clinical Evaluation of Bulk-fill Restorative Materials
An observational study of Caries; Dentin, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
High-viscosity glass ionomer cements have been developed to improve the weak mechanical properties of glass ionomer cements, increase wear resistance and improve their limited indications. There are limited clinical studies on the use of high-viscosity glass ionomer cements in areas with large cavities bearing stress. 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
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2021to 17 Sep 2023
- 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 that extends into the middle or outer one-third of the dentin (D1 or D2) in radiographs were included in the study. Visually, teeth with visible signs of enamel breakdown or moderate demineralization of dentin (ICDAS 4) in occlusal and smooth surfaces were included in the study.
Who may be able to join
- Voluntarily agreed to participate in the study after being informed about the study.
- Volunteer must not be under 18 years of age
- No systemic disease
- Having healthy oral hygiene
- As a result of clinical and radiographic examination, there is a carious lesion at D1 and D2 levels according to the caries classification method.
- The tooth to be restored is vital
Who cannot join
- Refusal to participate in the study after being informed about the study
- The patient has a history of teeth grinding
- Volunteer must be under 18 years of age
- The volunteer is undergoing or will begin orthodontic treatment
- The volunteer has a serious systemic disease
- The tooth to be restored has endodontic and periodontal problems
- Volunteer's pregnancy status
- Extraction of one of the teeth opposite or in contact with the tooth to be restored
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of High-viscosity Glass-hybrid Systems Compared With a Bulk Fill Composite Resin in Different Cavity Type
High-viscosity glass ionomer cements have been developed to improve the weak mechanical properties of glass ionomer cements, increase wear resistance and improve their limited indications. There are limited clinical studies on the use of high-viscosity glass ionomer cements in areas with large cavities bearing stress. The aim of this study is to compare the clinical performance of two different high-viscosity glass ionomer cements with a bulk-fill resin composite in different cavities.
Read the detailed description
This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in Class I, II, and V 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 marginal discoloration, fracture and retention, marginal adaptation, post-operative sensitivity, secondary caries, color match and difference criteria were examined.
Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. 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 Wilcoxon Signed rank 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 different restorative materials
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 posted31 Oct 2023
- Study start11 Oct 2021
- Primary completion15 Jul 2022
- Study completion17 Sep 2023
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
- 160 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 53 Karadaş, PhD, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109987
- Sponsor's protocol ID
- RTEUDHFMKARADAS002
- Status last verified
- Feb 2024
- First submitted
- 25 Oct 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 High-viscosity Glass-hybrid Systems Compared With a Bulk Fill Composite Resin in Different Cavity Type
- ClinicalTrials.gov ID
- NCT06109987
- Acronym / sponsor ID
- RTEUDHFMKARADAS002
- Conditions
- Caries; Dentin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 17 Sep 2023 (actual)
- First posted
- 31 Oct 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.
High-viscosity glass ionomer cements have been developed to improve the weak mechanical properties of glass ionomer cements, increase wear resistance and improve their limited indications. There are limited clinical studies on the use of high-viscosity glass ionomer cements in areas with large cavities bearing stress. The aim of this study is to compare the clinical performance of two different high-viscosity glass ionomer cements with a bulk-fill resin composite in different cavities.
Detailed description
This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in Class I, II, and V 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 marginal discoloration, fracture and retention, marginal adaptation, post-operative sensitivity, secondary caries, color match and difference criteria were examined.
Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. 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 Wilcoxon Signed rank 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 that extends into the middle or outer one-third of the dentin (D1 or D2) in radiographs were included in the study. Visually, teeth with visible signs of enamel breakdown or moderate demineralization of dentin (ICDAS 4) in occlusal and smooth surfaces were included in the study.
Key inclusion criteria (6 listed)
- Voluntarily agreed to participate in the study after being informed about the study.
- Volunteer must not be under 18 years of age
- No systemic disease
- Having healthy oral hygiene
- As a result of clinical and radiographic examination, there is a carious lesion at D1 and D2 levels according to the caries classification method.
Key exclusion criteria (8 listed)
- Refusal to participate in the study after being informed about the study
- The patient has a history of teeth grinding
- Volunteer must be under 18 years of age
- The volunteer is undergoing or will begin orthodontic treatment
- The volunteer has a serious systemic disease
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 different restorative materials
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
Related trials for Caries; Dentin
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Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
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Outcome of Selective Caries Removal Performed by Undergraduate Students
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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 53 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 6 inclusion and 8 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 different restorative materials (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.