Dental CariesNCT06393270
5-year Clinical Follow-up of Restorative Materials
An observational study of Dental Caries and Class II Dental Caries, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Materials to be used as permanent filling materials in Class II restorations are still an essential field of study. This study aims to evaluate the 5-year clinical performance of Class II restorations performed with different bulk-fill restorative materials. The study was planned as an observational clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dental Caries, Class II Dental Caries
- What is being tested?
- Modified US Public Health Service (USPHS) criteria
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 15 Dec 2022
- 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 to 50 years
- All sexes
- Adult
Study population: Seventy-nine patients (50 females, 29 males) between the ages of 18 and 53, and 192 restorations meeting the criteria were included in the study.
Who may be able to join
- Patients who were;
- older than 18 years old
- had good general health and oral hygiene
- had interface restorations of similar size in their premolars and molars
- were able to attend control appointments were included The teeth were determined as follows;
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- in contact with the opposing tooth
- exposed to normal occlusal forces on the dentition
- restoration width not exceeding 1⁄2 of the intercuspal distance
- normal response to vitality tests without periodontal pathology
Who cannot join
- Patients with;
- poor oral hygiene
- those with active periodontal disease
- those with severe bruxism
- pregnant and lactating women
- endodontically treated teeth were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 5-year Clinical Follow-up of Bulk-fill Restorative Materials in Class II Restorations
Materials to be used as permanent filling materials in Class II restorations are still an essential field of study. This study aims to evaluate the 5-year clinical performance of Class II restorations performed with different bulk-fill restorative materials.
The study was planned as an observational clinical trial. In the study, Class II restorations performed with Tetric Bulk Fill (TBF) and Filtek Bulk Fill (FBF) composites and Equia Forte Fil (EF) will be evaluated. Fifty-one patients and 119 restorations will be included in the study. Restorations will be assessed in terms of modified United States Public Health Service (USPHS) criteria during the 5th year. Cochran Q, Pearson chi-square, and Fisher-Freeman-Halton tests will be used for statistical analysis.
- Conditions
- Dental Caries, Class II Dental Caries
- Being tested
- Modified US Public Health Service (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.
Modified US Public Health Service (USPHS) criteriaDiagnostic test
Dental caries classification system
| Study group | Role | What they receive |
|---|---|---|
| Equia Forte Fil | High-viscosity glass ionomer cement Receives: Diagnostic Test: Modified US Public Health Service (USPHS) criteria | |
| Tetric Bulk Fill | Bulk-fill composite material Receives: Diagnostic Test: Modified US Public Health Service (USPHS) criteria | |
| Filtek Bulk Fill | Bulk-fill composite material Receives: Diagnostic Test: Modified US Public Health Service (USPHS) criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
At the control appointment, it was determined whether there was material loss in the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.
Measured: 5th year.
Color Match
At the control appointment, it was determined whether the restoration's color harmony with the adjacent tooth tissue was maintained. The scale used includes the characters A, B, and C. A is the best clinical result.
Measured: 5th year.
Marginal Adaptation
At the follow-up appointment, it was determined whether there was any deterioration in the marginal adaptation of the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.
Measured: 5th year.
Marginal Discoloration
At the control appointment, it was determined whether there was any color change at the edges of the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.
Measured: 5th year.
Secondary Caries
At the follow-up appointment, it was determined whether there was any decay under the restoration. The scale used includes the characters A and C. A is the best clinical result.
Measured: 5th year.
Surface Texture
At the control appointment, it was determined whether the restoration surface had a defect. The scale used includes the characters A, B, and C. A is the best clinical result.
Measured: 5th year.
Anatomical Form
At the control appointment, it was determined whether the restoration maintained its anatomical form. The scale used includes the characters A, B, and C. A is the best clinical result.
Measured: 5th year.
Postoperative Sensitivity
At the follow-up appointment, it was determined whether there was postoperative sensitivity after the restorative procedure. The scale used includes the characters A, B, and C. A is the best clinical result.
Measured: 5th year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Nov 2017
- Primary completion1 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gurses, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393270
- Sponsor's protocol ID
- SelcukD
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gurses M, Inan B, Cobanoglu N, Turkmen ATK. Five-year clinical follow-up of bulk-fill restorative materials in class II restorations. Dent Mater J. 2024 Sep 28;43(5):746-754. doi: 10.4012/dmj.2024-132. Epub 2024 Sep 10.
PubMed 39261021
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-year Clinical Follow-up of Bulk-fill Restorative Materials in Class II Restorations
- ClinicalTrials.gov ID
- NCT06393270
- Acronym / sponsor ID
- SelcukD
- Conditions
- Dental Caries, Class II Dental Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 1 May 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.
Materials to be used as permanent filling materials in Class II restorations are still an essential field of study. This study aims to evaluate the 5-year clinical performance of Class II restorations performed with different bulk-fill restorative materials.
The study was planned as an observational clinical trial. In the study, Class II restorations performed with Tetric Bulk Fill (TBF) and Filtek Bulk Fill (FBF) composites and Equia Forte Fil (EF) will be evaluated. Fifty-one patients and 119 restorations will be included in the study. Restorations will be assessed in terms of modified United States Public Health Service (USPHS) criteria during the 5th year. Cochran Q, Pearson chi-square, and Fisher-Freeman-Halton tests will be used for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Equia Forte Fil | – | Diagnostic Test: Modified US Public Health Service (USPHS) criteriaHigh-viscosity glass ionomer cement |
| Tetric Bulk Fill | – | Diagnostic Test: Modified US Public Health Service (USPHS) criteriaBulk-fill composite material |
| Filtek Bulk Fill | – | Diagnostic Test: Modified US Public Health Service (USPHS) criteriaBulk-fill composite material |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Seventy-nine patients (50 females, 29 males) between the ages of 18 and 53, and 192 restorations meeting the criteria were included in the study.
Key inclusion criteria (10 listed)
- Patients who were;
- <!-- -->
Key exclusion criteria (6 listed)
- Patients with;
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 |
|---|---|---|
| Modified US Public Health Service (USPHS) criteriaDental caries classification system | Diagnostic test | Equia Forte Fil, Filtek Bulk Fill, Tetric Bulk Fill |
Primary outcome
Retention
Time frame: 5th year.
At the control appointment, it was determined whether there was material loss in the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.
Color Match
Time frame: 5th year.
At the control appointment, it was determined whether the restoration's color harmony with the adjacent tooth tissue was maintained. The scale used includes the characters A, B, and C. A is the best clinical result.
Marginal Adaptation
Time frame: 5th year.
At the follow-up appointment, it was determined whether there was any deterioration in the marginal adaptation of the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.
Marginal Discoloration
Time frame: 5th year.
At the control appointment, it was determined whether there was any color change at the edges of the restoration. The scale used includes the characters A, B, and C. A is the best clinical result.
Secondary Caries
Time frame: 5th year.
At the follow-up appointment, it was determined whether there was any decay under the restoration. The scale used includes the characters A and C. A is the best clinical result.
Surface Texture
Time frame: 5th year.
At the control appointment, it was determined whether the restoration surface had a defect. The scale used includes the characters A, B, and C. A is the best clinical result.
Anatomical Form
Time frame: 5th year.
At the control appointment, it was determined whether the restoration maintained its anatomical form. The scale used includes the characters A, B, and C. A is the best clinical result.
Postoperative Sensitivity
Time frame: 5th year.
At the follow-up appointment, it was determined whether there was postoperative sensitivity after the restorative procedure. The scale used includes the characters A, B, and C. A is the best clinical result.
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 1 May 2024.
- Derived from this study: PubMed 39261021Gurses M, Inan B, Cobanoglu N, Turkmen ATK. Five-year clinical follow-up of bulk-fill restorative materials in class II restorations. Dent Mater J. 2024 Sep 28;43(5):746-754. doi: 10.4012/dmj.2024-132. Epub 2024 Sep 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dental Caries and Class II Dental Caries, run by Selcuk 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 10 inclusion and 6 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 1 May 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?
Retention (time frame: 5th year.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06393270, which also lists 1 linked publication.
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 1 May 2024.