Dental Caries in ChildrenPhase 4NCT03516838
Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth
A Phase 4 study testing ACTIVA™ BioACTIVE and Compomer in people with Dental Caries in Children, run by University Ghent at 1 site in Belgium.
Trial summary
A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional filling material (compomer) to restore decayed deciduous teeth in children Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- ACTIVA™ BioACTIVE and Compomer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 4
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children with American Society of Anesthesiologists (ASA) I score from both gender aged between three and ten years
- Vital decayed deciduous molar with proximal enamel/dentine caries
- At least one decayed tooth on each side of the mouth (split mouth)
- Pt is treatable in the dental chair
- Parents agreed to participate in the study and signed the informed consent
Who cannot join
- Patients with medical conditions or systemic disease
- Anxious or uncooperative patients who are not treatable in the dental chair
- Any symptoms like: pain, swelling, abscess or fistula.
- Extensive caries, dental developmental disturbance, pathological mobility, pulp exposure or indication for pulp therapy
- Patients with one decayed tooth in the whole mouth (not split mouth)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of a New Bioactive Ionic Resin Material (ACTIVA™ BioACTIVE) Versus Compomer for Class II Restorations in Primary Molars: A Split Mouth Randomized Clinical Trial
A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional filling material (compomer) to restore decayed deciduous teeth in children
Read the detailed description
A tooth decay in deciduous teeth has to be restored with proper filling material. ACTIVA™ BioACTIVE is a new filling material which has the ability to release and recharge fluoride in the oral cavity which is important for preventing further tooth decay. In this study we will compare this new filling material with Compomer (the traditional control filling material) by restoring decayed deciduous molars with one of the mentioned filling materials.
Both filling materials have no reported adverse effect and used regularly in the dental practice.
The treatment procedure is performed in healthy children from both genders with decayed deciduous molars aged between 5 to 10 years by one operator in the dental chair under local anesthesia in the department of pediatric dentistry and special care, Ghent University hospital, Ghent, Belgium.
At least 35 teeth is needed to demonstrate an effect. Each material is placed randomly based on randomization done by the computer. Each participant will receive both types of treatments, one type on each side of the mouth.
The participants will come back each six months to check the success of each treatment group by two trained dentists other than the operator. and to check whether the control group performs similar, better or worse than the control group.
The duration of treatment procedure of both treatment groups is recorded and compared to check if one filling material takes less time than the other to placed in the oral cavity.
- Conditions
- Dental Caries in Children
- Being tested
- ACTIVA™ BioACTIVE, Compomer
- Keywords
- Dental caries, Class II, Primary molar, Restorative material, Bioactive material, Compomer, Activa bioactive, Ryge 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.
ACTIVA™ BioACTIVEDrug
Also called ACTIVA
Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth
CompomerDrug
Also called Dyract
Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth
| Study group | Role | What they receive |
|---|---|---|
| ACTIVA™ BioACTIVE | Experimental | Restoring cavity using ACTIVA filling material Receives: Drug: ACTIVA™ BioACTIVE |
| Compomer | Active comparator | Restoring cavity using compomer filling material Receives: Drug: Compomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
Measured: 6 months follow-up
Clinical evaluation
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
Measured: 12 months follow-up
Radiographic evaluation
Check the filling radiographically based on Rx photo by a blinded and calibrated assessor
Measured: 12 months follow-up
Secondary outcomes (1)
Time needed to place the filling material
Time since start placing the filling material until finishing the restoration is recorded and compared between the two groups to investigate whether both materials take the same time to be placed in the oral cavity.
Measured: Immediately after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
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 Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by University GhentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Experimental prospective double blinded split-mouth randomized controlled trial . Each patient receive both types of treatment in the oral cavity, one type of the treatment on each side. The patients act as their control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Martens, PhD, Study director, PaeCoMeDis Research group,Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516838
- Sponsor's protocol ID
- EC UZG 2016/1050 - 1051
- Status last verified
- Nov 2023
- First submitted
- 22 Apr 2018
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available in the literature in the manuscript after publication
Publications
Banon R, Vandenbulcke J, Van Acker J, Martens L, De Coster P, Rajasekharan S. Two-year clinical and radiographic evaluation of ACTIVA BioACTIVE versus Compomer (Dyract(R) eXtra) in the restoration of class-2 cavities of primary molars: a non-inferior split-mouth randomised clinical trial. BMC Oral Health. 2024 Apr 10;24(1):437. doi: 10.1186/s12903-024-04132-w.
PubMed 38600533
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of a New Bioactive Ionic Resin Material (ACTIVA™ BioACTIVE) Versus Compomer for Class II Restorations in Primary Molars: A Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03516838
- Acronym / sponsor ID
- EC UZG 2016/1050 - 1051
- Conditions
- Dental Caries in Children
- Keywords
- Dental caries, Class II, Primary molar, Restorative material, Bioactive material, Compomer, Activa bioactive, Ryge criteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 May 2018 (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.
A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional filling material (compomer) to restore decayed deciduous teeth in children
Detailed description
A tooth decay in deciduous teeth has to be restored with proper filling material. ACTIVA™ BioACTIVE is a new filling material which has the ability to release and recharge fluoride in the oral cavity which is important for preventing further tooth decay. In this study we will compare this new filling material with Compomer (the traditional control filling material) by restoring decayed deciduous molars with one of the mentioned filling materials.
Both filling materials have no reported adverse effect and used regularly in the dental practice.
The treatment procedure is performed in healthy children from both genders with decayed deciduous molars aged between 5 to 10 years by one operator in the dental chair under local anesthesia in the department of pediatric dentistry and special care, Ghent University hospital, Ghent, Belgium.
At least 35 teeth is needed to demonstrate an effect. Each material is placed randomly based on randomization done by the computer. Each participant will receive both types of treatments, one type on each side of the mouth.
The participants will come back each six months to check the success of each treatment group by two trained dentists other than the operator. and to check whether the control group performs similar, better or worse than the control group.
The duration of treatment procedure of both treatment groups is recorded and compared to check if one filling material takes less time than the other to placed in the oral cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental prospective double blinded split-mouth randomized controlled trial . Each patient receive both types of treatment in the oral cavity, one type of the treatment on each side. The patients act as their control
| Arm | Type | Receives |
|---|---|---|
| ACTIVA™ BioACTIVE | Experimental | Drug: ACTIVA™ BioACTIVERestoring cavity using ACTIVA filling material |
| Compomer | Active comparator | Drug: CompomerRestoring cavity using compomer filling material |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children with American Society of Anesthesiologists (ASA) I score from both gender aged between three and ten years
- Vital decayed deciduous molar with proximal enamel/dentine caries
- At least one decayed tooth on each side of the mouth (split mouth)
- Pt is treatable in the dental chair
- Parents agreed to participate in the study and signed the informed consent
Key exclusion criteria (5 listed)
- Patients with medical conditions or systemic disease
- Anxious or uncooperative patients who are not treatable in the dental chair
- Any symptoms like: pain, swelling, abscess or fistula.
- Extensive caries, dental developmental disturbance, pathological mobility, pulp exposure or indication for pulp therapy
- Patients with one decayed tooth in the whole mouth (not split mouth)
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 |
|---|---|---|
| ACTIVA™ BioACTIVEAlso: ACTIVARestorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth | Drug | ACTIVA™ BioACTIVE |
| CompomerAlso: DyractRestorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth | Drug | Compomer |
Primary outcome
Clinical evaluation
Time frame: 6 months follow-up
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
Clinical evaluation
Time frame: 12 months follow-up
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
Radiographic evaluation
Time frame: 12 months follow-up
Check the filling radiographically based on Rx photo by a blinded and calibrated assessor
1 secondary outcome
Time needed to place the filling material
Time frame: Immediately after each intervention
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 22 Nov 2023.
- Derived from this study: PubMed 38600533Banon R, Vandenbulcke J, Van Acker J, Martens L, De Coster P, Rajasekharan S. Two-year clinical and radiographic evaluation of ACTIVA BioACTIVE versus Compomer (Dyract(R) eXtra) in the restoration of class-2 cavities of primary molars: a non-inferior split-mouth randomised clinical trial. BMC Oral Health. 2024 Apr 10;24(1):437. doi: 10.1186/s12903-024-04132-w.
- Individual participant dataSharing planned: Yes. The data will be available in the literature in the manuscript after publication
Related trials for Dental Caries in Children
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Prevention of Dental Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
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.
Luc Martens, PhD study director
PaeCoMeDis Research group,Ghent University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACTIVA™ BioACTIVE and Compomer in people with Dental Caries in Children, run by University Ghent 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 5 inclusion and 5 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 22 Nov 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical evaluation (time frame: 6 months follow-up). The study lists 3 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 NCT03516838, 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 22 Nov 2023.