Class III Dental CariesClass-IIINCT05843734
Clinical Performance of Glass-hybrid in the Treatment of Class III Restorations
A study testing Equia forte HT in people with Class III Dental Caries, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in class III lesions. The lesions will be restored with glass hybrid restorative (Equia Forte) or anterior composite resin (G-aenial Anterior). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Class III Dental Caries
- What is being tested?
- Equia forte HT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2023to Dec 2025
- 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
- The participant must be at least 18 years of age or older
- The participant has at least two class III lesions and the lesions are in symmetrical teeth located in the right and left arch
- The lesion covers at most 2/3 and at least 1/3 of the dentin
- Participant voluntarily signing the informed consent form
- The participant does not have a physical disability that may prevent them from coming to the control.
- Absence of a periapical pathology in the involved tooth
Who cannot join
- Having systemic disorders that may prevent the participant from regularly attending treatment and control appointments.
- Having severe periodontal problems in the tooth planned to be treated
- Absence of the opposite of the tooth and not participating in chewing
- Lesions which is limited with the enamel tissue
- Teeth with lesions that are too large to be restored
- Patients with anterior malocclusion
- Patients with parafunctional habits.
- Mentally disabled patients.
Trial locations and contacts
2 sites in 1 country.
UZAY Koç VURAL contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Hacettepe University School of Dentistry
Ankara, 06100
Uzay Koc vural, PhD. DDS, +90 5072122626, uzaykoc@gmail.com
Esra Ergin, PhD. DDS
- Recruiting
Hacettepe University
Ankara, 06100
Uzay Koc vural, PhD. DDS, +90 5072122626, uzaykoc@gmail.com
Esra Ergin, PhD. DDS
About this study
Official title: Clinical Performance of Glass Hybrid Restorations in the Treatment of Class III Lesions: A Randomized Clinical Trial
This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in class III lesions. The lesions will be restored with glass hybrid restorative (Equia Forte) or anterior composite resin (G-aenial Anterior). Restorations will be evaluated after 24 months according to FDI criteria and the data will be analyzed.
Read the detailed description
The aim of this study was to comparatively evaluate the clinical performance of a glass-hybrid-restorative with an anterior composite resin (G-aenial Anterior) in class III lesions.
Participants who are 18 years of age or older and healthy, and who have applied to the Restorative Dentistry Department of Hacettepe University Faculty of Dentistry to receive treatment for class III lesions on their front teeth will be included in the study. After explaining the purpose and conditions of the study, they will be asked to sign an informed consent form. The gender, age, and tooth numbers of the participants to be treated will be recorded. 100 upper incisors of 50 patients will be treated, with attention paid to the balanced distribution of teeth in the right and left arches. The "split-mouth" model will be used in the study, with two teeth included in one mouth and each restorative material placed in one tooth. The restorative material to be placed on the teeth will be determined randomly. Before starting the restoration, papers with the names of both materials will be placed in envelopes, and then the assistant staff will be asked to randomly select one of the envelopes during the restoration stage to provide randomization.Data were will be analyzed with Chi- Square, Fisher's Exact Test, Mann U tests
- Conditions
- Class III Dental Caries
- Being tested
- Equia forte HT
- Keywords
- Glass hybrid restorative, Class III, Anterior restoration, FDI criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equia forte HTProcedure or surgery
Also called G-Aenial anterior
Restoration of anterior class III caries lesions
| Study group | Role | What they receive |
|---|---|---|
| Equia forte HT (glass-hybrid) group | Experimental | This study planned to investigate the clinical performance of Equia Forte HT (permanent glass hybrid restorative) in the treatment of anterior class III restorations. This arm of the study is the group whose effectiveness was investigated. The results will be evaluated by comparing with a traditional anterior resin composite in terms of functional, biological and aesthetic properties. Receives: Procedure: Equia forte HT |
| "G-Aenial anterior" | Active comparator | This group will serve as a "control". Equia forte HT (glass-hybrid) restorations will compare with the "G-Aenial anterior" anterior resin composite restorations. Receives: Procedure: Equia forte HT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional properties
The primary factor for determining the clinical performance of a restorative material is the Functional properties. Visual tactile examination tools will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-, 18- and 24- months. The functional properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.
Measured: 2 years
Esthetic properties
Second outcome is esthetic properties. The secondary factor for determining the clinical performance of a restorative material is the Esthetic properties. Visual examination will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-, 18- and 24- months. The Esthetic properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jan 2023
- Primary completionFeb 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class III Dental CariesStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzay Koc, Hacettepe University
- Investigators
- UZAY Koç VURAL, PhD.DDS, Principal investigator, Hacettepe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843734
- Sponsor's protocol ID
- 2022/12-03
- Acronym
- Class-III
- Status last verified
- May 2023
- First submitted
- 28 Oct 2022
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Glass Hybrid Restorations in the Treatment of Class III Lesions: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05843734
- Acronym / sponsor ID
- Class-III / 2022/12-03
- Conditions
- Class III Dental Caries
- Keywords
- Glass hybrid restorative, Class III, Anterior restoration, FDI criteria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 May 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.
This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in class III lesions. The lesions will be restored with glass hybrid restorative (Equia Forte) or anterior composite resin (G-aenial Anterior). Restorations will be evaluated after 24 months according to FDI criteria and the data will be analyzed.
Detailed description
The aim of this study was to comparatively evaluate the clinical performance of a glass-hybrid-restorative with an anterior composite resin (G-aenial Anterior) in class III lesions.
Participants who are 18 years of age or older and healthy, and who have applied to the Restorative Dentistry Department of Hacettepe University Faculty of Dentistry to receive treatment for class III lesions on their front teeth will be included in the study. After explaining the purpose and conditions of the study, they will be asked to sign an informed consent form. The gender, age, and tooth numbers of the participants to be treated will be recorded. 100 upper incisors of 50 patients will be treated, with attention paid to the balanced distribution of teeth in the right and left arches. The "split-mouth" model will be used in the study, with two teeth included in one mouth and each restorative material placed in one tooth. The restorative material to be placed on the teeth will be determined randomly. Before starting the restoration, papers with the names of both materials will be placed in envelopes, and then the assistant staff will be asked to randomly select one of the envelopes during the restoration stage to provide randomization.Data were will be analyzed with Chi- Square, Fisher's Exact Test, Mann U tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equia forte HT (glass-hybrid) group | Experimental | Procedure: Equia forte HTThis study planned to investigate the clinical performance of Equia Forte HT (permanent glass hybrid restorative) in the treatment of anterior class III restorations. This arm of the study is the group whose effectiveness was investigated. The results will be evaluated by comparing with a traditional anterior resin composite in terms of functional, biological and aesthetic properties. |
| "G-Aenial anterior" | Active comparator | Procedure: Equia forte HTThis group will serve as a "control". Equia forte HT (glass-hybrid) restorations will compare with the "G-Aenial anterior" anterior resin composite restorations. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The participant must be at least 18 years of age or older
- The participant has at least two class III lesions and the lesions are in symmetrical teeth located in the right and left arch
- The lesion covers at most 2/3 and at least 1/3 of the dentin
- Participant voluntarily signing the informed consent form
- The participant does not have a physical disability that may prevent them from coming to the control.
Key exclusion criteria (8 listed)
- Having systemic disorders that may prevent the participant from regularly attending treatment and control appointments.
- Having severe periodontal problems in the tooth planned to be treated
- Absence of the opposite of the tooth and not participating in chewing
- Lesions which is limited with the enamel tissue
- Teeth with lesions that are too large to be restored
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 |
|---|---|---|
| Equia forte HTAlso: G-Aenial anteriorRestoration of anterior class III caries lesions | Procedure or surgery | "G-Aenial anterior", Equia forte HT (glass-hybrid) group |
Primary outcome
Functional properties
Time frame: 2 years
The primary factor for determining the clinical performance of a restorative material is the Functional properties. Visual tactile examination tools will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-, 18- and 24- months. The functional properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.
Esthetic properties
Time frame: 2 years
Second outcome is esthetic properties. The secondary factor for determining the clinical performance of a restorative material is the Esthetic properties. Visual examination will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-, 18- and 24- months. The Esthetic properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- 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.
UZAY Koç VURAL contact
UZAY Koç VURAL, PhD.DDS principal investigator
Hacettepe
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equia forte HT in people with Class III Dental Caries, run by Hacettepe University at 2 sites 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: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UZAY Koç VURAL, PhD. DDS (+90 5072122626, uzaykoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional properties (time frame: 2 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 6 May 2023.