CariesNCT05748327
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
A study testing Alcasite restorative material and Bulk fill glass hybrid restorative material in people with Caries and Defective Restorations, run by Ivoclar Vivadent AG at 1 site in Belgium.
Trial summary
This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Caries, Defective Restorations
- What is being tested?
- Alcasite restorative material and Bulk fill glass hybrid restorative material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Nov 2022to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject's age between 18 and 65 years old
- Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars
- Vital teeth
- 2 restorations per patient: both cavities should have comparable size and dimensions
- Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included)
- Low to moderate caries rate/normal periodontal status with good home care
Who cannot join
- Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)
- Pulp exposure or signs of pulpal infection
- No signs of pulpitis or hypersensitivity (Visual analog scale < 3 on biting and temperature sensitivity)
- History of allergy to glass ionomer, acrylate/methacrylate monomers
- Pregnancy
- Chronic disease with oral manifestations or primary oral pathology
Show all 10Show fewer
- Bad oral hygiene
- High caries rate or periodontal problems
- Absence of antagonists
- Absence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial (RCT) of the New Tooth-colored Restorative Material 'Cention Forte' (Ivoclar Vivadent) vs. 'Equia Forte HT' (GC) in Class-I/II Cavities
This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).
Read the detailed description
The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.
- Conditions
- Caries, Defective Restorations
- Being tested
- Alcasite restorative material, Bulk fill glass hybrid restorative material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcasite restorative materialDevice
Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), conditioning with primer, mixing alcasite capsula, place restoration, polymerizing and finishing
Bulk fill glass hybrid restorative materialDevice
Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), mixing bulk fill glass hybrid capsula, conditioning, place restoration, apply coating, polymerizing and finishing
| Study group | Role | What they receive |
|---|---|---|
| Alcasite restorative material | Experimental | Not described Receives: Device: Alcasite restorative material |
| Bulk fill glass hybrid restorative material | Active comparator | Not described Receives: Device: Bulk fill glass hybrid restorative material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3)
Measured: 5 years
Secondary outcomes (3)
Success Rate
assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3)
Measured: 6 months to 3 years
Survival Rate
assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Survival: Score equal to/above 4)
Measured: 6 months to 5 years
Quality criteria (Clinical performance)
assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations
Measured: 6 months to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start22 Nov 2022
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
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 CariesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-Mouth Design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748327
- Sponsor's protocol ID
- LL4199644
- Other IDs
- S66086
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Etiennot L, Cardoso MV, Degroote A, Meerbeek BV, Peumans M. Early Clinical Performance of Two Powder-Liquid Restoratives in Class-I/II Cavities. J Adhes Dent. 2025 Oct 17;27:195-207. doi: 10.3290/j.jad.c_2307.
PubMed 41104522
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial (RCT) of the New Tooth-colored Restorative Material 'Cention Forte' (Ivoclar Vivadent) vs. 'Equia Forte HT' (GC) in Class-I/II Cavities
- ClinicalTrials.gov ID
- NCT05748327
- Acronym / sponsor ID
- LL4199644
- Conditions
- Caries, Defective Restorations
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Collaborators
- KU Leuven
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 28 Feb 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 randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).
Detailed description
The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-Mouth Design
| Arm | Type | Receives |
|---|---|---|
| Alcasite restorative material | Experimental | Device: Alcasite restorative material |
| Bulk fill glass hybrid restorative material | Active comparator | Device: Bulk fill glass hybrid restorative material |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject's age between 18 and 65 years old
- Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars
- Vital teeth
- 2 restorations per patient: both cavities should have comparable size and dimensions
- Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included)
Key exclusion criteria (10 listed)
- Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)
- Pulp exposure or signs of pulpal infection
- No signs of pulpitis or hypersensitivity (Visual analog scale < 3 on biting and temperature sensitivity)
- History of allergy to glass ionomer, acrylate/methacrylate monomers
- Pregnancy
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 |
|---|---|---|
| Alcasite restorative materialCavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), conditioning with primer, mixing alcasite capsula, place restoration, polymerizing and finishing | Device | Alcasite restorative material |
| Bulk fill glass hybrid restorative materialCavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), mixing bulk fill glass hybrid capsula, conditioning, place restoration, apply coating, polymerizing and finishing | Device | Bulk fill glass hybrid restorative material |
Primary outcome
Success Rate
Time frame: 5 years
assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3)
3 secondary outcomes
Success Rate
Time frame: 6 months to 3 years
Survival Rate
Time frame: 6 months to 5 years
Quality criteria (Clinical performance)
Time frame: 6 months to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 41104522Etiennot L, Cardoso MV, Degroote A, Meerbeek BV, Peumans M. Early Clinical Performance of Two Powder-Liquid Restoratives in Class-I/II Cavities. J Adhes Dent. 2025 Oct 17;27:195-207. doi: 10.3290/j.jad.c_2307.
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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?
A study testing Alcasite restorative material and Bulk fill glass hybrid restorative material in people with Caries and Defective Restorations, run by Ivoclar Vivadent AG at 1 site in Belgium.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 29 Mar 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Success Rate (time frame: 5 years). 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 NCT05748327, 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 29 Mar 2024.