Dental CariesNCT06346756
Clinical Evaluation of Class II Restorations
A study testing Treatment of dental caries. in people with Dental Caries and Dental Caries Class II, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins. The study included 71 patients and 140 restorations. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Caries Class II
- What is being tested?
- Treatment of dental caries.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 Jul 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A patient presenting with;
- over 18 years of age
- a normal periodontal status and good general health
- proximal caries that are similar in size to premolar and molar teeth
- vital teeth
- teeth in contact with the opposing tooth and subjected to normal occlusal forces
- attend follow-up appointments
Who cannot join
- poor oral hygiene status
- those with severe or chronic periodontitis
- absence of adjacent and antagonist teeth
- potential behavioral problems (e.g. bruxism)
- allergy to any product used in the study
- exposure of the pulp during cavity preparation
- systemically unhealthy
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites
This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.
The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p<0.05).
- Conditions
- Dental Caries, Dental Caries Class II
- Being tested
- Treatment of dental caries.
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of dental caries.Other
The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.
| Study group | Role | What they receive |
|---|---|---|
| G-aenial A'CHORD universal composite | Experimental | Not described Receives: Other: Treatment of dental caries. |
| Tetric Prime universal composite | Experimental | Not described Receives: Other: Treatment of dental caries. |
| Filtek Ultimate universal composite | Experimental | Not described Receives: Other: Treatment of dental caries. |
| G-aenial Universal Injectable composite | Experimental | Not described Receives: Other: Treatment of dental caries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
No loss of restorative material
Measured: seventh day, sixth month, twelfth month
Secondary outcomes (7)
color match
The restoration matches the adjacent tooth structure in color and translucency
Measured: seventh day, sixth month, twelfth month
marginal adaptation
There is no visible evidence of a crevice along the margin into which the explorer will penetrate
Measured: seventh day, sixth month, twelfth month
marginal discoloration
There is no discoloration anywhere on the margin between the restoration and the tooth structure
Measured: seventh day, sixth month, twelfth month
surface texture
The surface of the restoration does not have any defects
Measured: seventh day, sixth month, twelfth month
anatomical form
The restoration is continuous with the existing anatomic form
Measured: seventh day, sixth month, twelfth month
secondary caries
No evidence of secondary caries
Measured: seventh day, sixth month, twelfth month
postoperative sensitivity
No postoperative sensitivity, after the restorative procedure and during the study
Measured: seventh day, sixth month, twelfth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gurses, Selcuk University
- Investigators
- Merve Gürses, Principal investigator, Selcuk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346756
- Sponsor's protocol ID
- SelcukA
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2024
- Last updated
- 5 Jun 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites
- ClinicalTrials.gov ID
- NCT06346756
- Acronym / sponsor ID
- SelcukA
- Conditions
- Dental Caries, Dental Caries Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 4 Apr 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.
This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.
The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G-aenial A'CHORD universal composite | Experimental | Other: Treatment of dental caries. |
| Tetric Prime universal composite | Experimental | Other: Treatment of dental caries. |
| Filtek Ultimate universal composite | Experimental | Other: Treatment of dental caries. |
| G-aenial Universal Injectable composite | Experimental | Other: Treatment of dental caries. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A patient presenting with;
- over 18 years of age
- a normal periodontal status and good general health
- proximal caries that are similar in size to premolar and molar teeth
- vital teeth
Key exclusion criteria (8 listed)
- poor oral hygiene status
- those with severe or chronic periodontitis
- absence of adjacent and antagonist teeth
- potential behavioral problems (e.g. bruxism)
- allergy to any product used in the study
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 |
|---|---|---|
| Treatment of dental caries.The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations. | Other | Filtek Ultimate universal composite, G-aenial A'CHORD universal composite, G-aenial Universal Injectable composite, Tetric Prime universal composite |
Primary outcome
Retention
Time frame: seventh day, sixth month, twelfth month
No loss of restorative material
7 secondary outcomes
color match
Time frame: seventh day, sixth month, twelfth month
marginal adaptation
Time frame: seventh day, sixth month, twelfth month
marginal discoloration
Time frame: seventh day, sixth month, twelfth month
surface texture
Time frame: seventh day, sixth month, twelfth month
anatomical form
Time frame: seventh day, sixth month, twelfth month
secondary caries
Time frame: seventh day, sixth month, twelfth month
postoperative sensitivity
Time frame: seventh day, sixth month, twelfth month
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 5 Jun 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.
Merve Gürses principal investigator
Selcuk University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of dental caries. in people with Dental Caries and Dental Caries Class II, 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 7 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 5 Jun 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: seventh day, sixth month, twelfth month). 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 5 Jun 2024.