Dental CariesNCT07212660
A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth
A study testing Fast curing mode and Conventional curing mode in people with Dental Caries and Insufficient Dental Filling, run by Ivoclar Vivadent AG at 2 sites in Switzerland.
Trial summary
The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries, Insufficient Dental Filling
- What is being tested?
- Fast curing mode and Conventional curing mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 Dec 2025to Oct 2027
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Consent of a legal representative (usually parents)
- 2 deciduous molars in the need of direct filling therapy class I and/or II in different quadrants (primary or secondary caries, filling loss)
- Classification of caries: caries of all sizes in deciduous molars are included unless they can be treated with fissure sealing (ICDAS 3, 4, 5)
- Sufficient language skills of legal representative and children
- Teeth in the need of indirect pulp capping if necessary (Operator decision)
Who cannot join
- Cognitive impairment not age-appropriate
- Sensitive tooth (pain at night, irritation-persistent pain, buccal swelling, percussion sensitivity)
- Teeth with severely resorbed roots (anormal tooth mobility)
- Direct pulp capping
- Pulpotomy of an adjacent tooth in the same appointment
- Noncompliant child
- Allergies to material or anaesthetics used in the study
- Sufficient isolation not possible
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
N|DENT Zahnarztpraxis
Herzogenbuchsee, Canton of Bern, 3360
Klaus Neuhaus, Prof. Dr. med. dent., 044 62 961 99 90, klaus.neuhaus@unibe.ch
- Recruiting
Zahnarztpraxis Chrüzhof
Willisau, Canton of Lucerne, 6130
Eirini Stratigaki, Dr. med. dent., 044 41 970 37 55, estratigaki@icloud.com
About this study
Official title: A Multi-center, Randomized-controlled, 12-month, Split-mouth, Non-inferiority Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy With a Flowable Bulk Fill Composite in Class I and II Deciduous Teeth
The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.
Read the detailed description
Dental interventions in young children are challenging due to limited compliance and anxiety. Moisture control during the placement of resin composite fillings is particularly difficult, as children need to remain calm. Reducing treatment time benefits both children and dentists.
The planned clinical investigation aims to evaluate the clinical performance and safety of posterior restorations on primary teeth using a flowable composite with a fast curing mode (5 seconds, 2000 mW/cm²) compared to a conventional curing mode (10 seconds, 1200 mW/cm²).
- Conditions
- Dental Caries, Insufficient Dental Filling
- Being tested
- Fast curing mode, Conventional curing mode
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast curing modeDevice
Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).
Conventional curing modeDevice
Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).
| Study group | Role | What they receive |
|---|---|---|
| Fast curing mode | Experimental | Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²). Receives: Device: Fast curing mode |
| Conventional curing mode | Other | Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²). Receives: Device: Conventional curing mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The assessment of postoperative pain will be done by using the Wong-Baker Faces Pain rating Scale and includes questions about type and duration of pain, intensity of pain and the type of stimulus causing the pain. Values of 0 and 2 in the Wong-Baker Faces Pain Rating Scale are considered as no pain and values >2 as pain.
Measured: 4-10 days after placement of the dental fillings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start18 Dec 2025
- Primary completionNov 2026 (estimated)
- Study completionOct 2027 (estimated)
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.
- 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: each patient receives 2 dental fillings (test and control treatment in the same patient)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212660
- Sponsor's protocol ID
- OTCS 369512033
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2025
- Last updated
- 25 Mar 2026
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized-controlled, 12-month, Split-mouth, Non-inferiority Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy With a Flowable Bulk Fill Composite in Class I and II Deciduous Teeth
- ClinicalTrials.gov ID
- NCT07212660
- Acronym / sponsor ID
- OTCS 369512033
- Conditions
- Dental Caries, Insufficient Dental Filling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Oct 2025 (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.
The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.
Detailed description
Dental interventions in young children are challenging due to limited compliance and anxiety. Moisture control during the placement of resin composite fillings is particularly difficult, as children need to remain calm. Reducing treatment time benefits both children and dentists.
The planned clinical investigation aims to evaluate the clinical performance and safety of posterior restorations on primary teeth using a flowable composite with a fast curing mode (5 seconds, 2000 mW/cm²) compared to a conventional curing mode (10 seconds, 1200 mW/cm²).
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: each patient receives 2 dental fillings (test and control treatment in the same patient)
| Arm | Type | Receives |
|---|---|---|
| Fast curing mode | Experimental | Device: Fast curing modeComposite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²). |
| Conventional curing mode | Other | Device: Conventional curing modeComposite restoration is cured with High mode (10 seconds with 1200 mW/cm²). |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Consent of a legal representative (usually parents)
- 2 deciduous molars in the need of direct filling therapy class I and/or II in different quadrants (primary or secondary caries, filling loss)
- Classification of caries: caries of all sizes in deciduous molars are included unless they can be treated with fissure sealing (ICDAS 3, 4, 5)
- Sufficient language skills of legal representative and children
- Teeth in the need of indirect pulp capping if necessary (Operator decision)
Key exclusion criteria (8 listed)
- Cognitive impairment not age-appropriate
- Sensitive tooth (pain at night, irritation-persistent pain, buccal swelling, percussion sensitivity)
- Teeth with severely resorbed roots (anormal tooth mobility)
- Direct pulp capping
- Pulpotomy of an adjacent tooth in the same appointment
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 |
|---|---|---|
| Fast curing modeComposite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²). | Device | Fast curing mode |
| Conventional curing modeComposite restoration is cured with High mode (10 seconds with 1200 mW/cm²). | Device | Conventional curing mode |
Primary outcome
Postoperative pain
Time frame: 4-10 days after placement of the dental fillings
The assessment of postoperative pain will be done by using the Wong-Baker Faces Pain rating Scale and includes questions about type and duration of pain, intensity of pain and the type of stimulus causing the pain. Values of 0 and 2 in the Wong-Baker Faces Pain Rating Scale are considered as no pain and values >2 as pain.
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 25 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast curing mode and Conventional curing mode in people with Dental Caries and Insufficient Dental Filling, run by Ivoclar Vivadent AG at 2 sites in Switzerland.
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 5 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 4-10 days after placement of the dental fillings). 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 25 Mar 2026.