Caries,DentalNCT06388746
Arresting Carious Lesions With Minimal Intervention Techniques
A study testing BRIX3000® and Riva Star Aqua, SDI Limited, Australia in people with Caries,Dental, run by National and Kapodistrian University of Athens.
Trial summary
A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- BRIX3000® and Riva Star Aqua, SDI Limited, Australia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4 to 8 years with a non-contributary medical history and sufficient compliance for the caries treatment will be included. The eligible children should have at least two carious primary molars (cavitated lesions up to 2/3 of dentin, corresponding to ICDAS 5 and 6) on different quadrants without any periapical pathology detected radiographically.
Who cannot join
- Children aged below 4 years and above 8 years, with compromised medical history and/or allergies, with clinical or radiographic signs or symptoms of pulp pathology and with developmental dental defects will be excluded.
Trial locations and contacts
No sites are listed yet.
Kyriaki Seremidi, Assist Prof contact
About this study
Official title: Minimal Intervention Techniques for Arresting Caries in Primary Molars: a Randomized Clinical Trial With 12 Months Follow-up.
A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars.
Read the detailed description
Fifty children (100 teeth) aged 4 to 8 years with a non-contributary medical history and at least two carious primary molars (ICDAS 5 and 6) on different quadrants will be randomly assigned to either treatment group, using computer-generated numbers.
Each cavitated lesion will be isolated with cotton rolls and air-dried before being treated with one of the two types of minimal intervention technique according to the manufacturer's instructions. After the application of the agents all teeth will be restored using a high viscosity glass ionomer cement.
Patients will be followed clinically at 6 and 12 months and radiographically at 12 months to evaluate success of the procedures.
- Conditions
- Caries,Dental
- Being tested
- BRIX3000®, Riva Star Aqua, SDI Limited, Australia
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIX3000®Other
A gel that when applied to the tooth completely removes carious tissues in a chemo mechanical way without rotary instruments. It contains an enzyme that has bactericidal, bacteriostatic and anti-inflammatory properties and proteolytic properties that help soften and break down decayed tissue without destroying the underlying healthy collagen fibers.
Riva Star Aqua, SDI Limited, AustraliaOther
A solution that contains 44,800 ppm F and 253,870 ppm Ag. It acts as a fluoride storage for the acid challenges, while inhibites demineralization of hydroxyapatite crystals and preserves collagen from degradation in demineralized tissues.
| Study group | Role | What they receive |
|---|---|---|
| Caries removal group | Experimental | Cavitated lesion will be isolated with cotton rolls and air-dried. Gel will be placed in the cavity and kept there for 60 seconds to allow for the decayed tissue to become softer. The softened tissue will be removed with a hand instrument. The gel will be reapplied, until complete removal of the carious tissue is achieved. Teeth will be restored using a high viscosity glass ionomer cement. Receives: Other: BRIX3000® |
| Caries arrest group | Active comparator | Cavitated lesion will be isolated with cotton rolls and air-dried. One drop of component 1 (38% Silver Fluoride (AgF) in water) will be applied for 60 seconds using a microbrush, followed by two drops of component 2 (potassium iodide) for 90 seconds. Teeth will be restored using a high viscosity glass ionomer cement. Receives: Other: Riva Star Aqua, SDI Limited, Australia |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation.
Measured: 6 and 12 month post-treatment
radiographic success
Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation.
Measured: 12 month post-treatment
Secondary outcomes (2)
Longevity and the quality of the final restoration
Evaluation of retention, marginal integrity, marginal discoloration, anatomic form and secondary caries using USPHS criteria.
Measured: 6 and 12 months post-treatment
Patient's acceptance
intensity or frequency of various symptoms, such as pain using the Visual Analogue Scale (VAS)
Measured: immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (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 Caries,DentalStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sotiria Gizani, National and Kapodistrian University of Athens
- Investigators
- Sotiria Gizani, Assoc Prof, Principal investigator, Department Of Paediatric Dentistry, National And Kapodistrian University Of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388746
- Sponsor's protocol ID
- NKUA
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Intervention Techniques for Arresting Caries in Primary Molars: a Randomized Clinical Trial With 12 Months Follow-up.
- ClinicalTrials.gov ID
- NCT06388746
- Acronym / sponsor ID
- NKUA
- Conditions
- Caries,Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 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.
A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars.
Detailed description
Fifty children (100 teeth) aged 4 to 8 years with a non-contributary medical history and at least two carious primary molars (ICDAS 5 and 6) on different quadrants will be randomly assigned to either treatment group, using computer-generated numbers.
Each cavitated lesion will be isolated with cotton rolls and air-dried before being treated with one of the two types of minimal intervention technique according to the manufacturer's instructions. After the application of the agents all teeth will be restored using a high viscosity glass ionomer cement.
Patients will be followed clinically at 6 and 12 months and radiographically at 12 months to evaluate success of the procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caries removal group | Experimental | Other: BRIX3000®Cavitated lesion will be isolated with cotton rolls and air-dried. Gel will be placed in the cavity and kept there for 60 seconds to allow for the decayed tissue to become softer. The softened tissue will be removed with a hand instrument. The gel will be reapplied, until complete removal of the carious tissue is achieved. Teeth will be restored using a high viscosity glass ionomer cement. |
| Caries arrest group | Active comparator | Other: Riva Star Aqua, SDI Limited, AustraliaCavitated lesion will be isolated with cotton rolls and air-dried. One drop of component 1 (38% Silver Fluoride (AgF) in water) will be applied for 60 seconds using a microbrush, followed by two drops of component 2 (potassium iodide) for 90 seconds. Teeth will be restored using a high viscosity glass ionomer cement. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 4 to 8 years with a non-contributary medical history and sufficient compliance for the caries treatment will be included. The eligible children should have at least two carious primary molars (cavitated lesions up to 2/3 of dentin, corresponding to ICDAS 5 and 6) on different quadrants without any periapical pathology detected radiographically.
Key exclusion criteria (1 listed)
- Children aged below 4 years and above 8 years, with compromised medical history and/or allergies, with clinical or radiographic signs or symptoms of pulp pathology and with developmental dental defects will be excluded.
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 |
|---|---|---|
| BRIX3000®A gel that when applied to the tooth completely removes carious tissues in a chemo mechanical way without rotary instruments. It contains an enzyme that has bactericidal, bacteriostatic and anti-inflammatory properties and proteolytic properties that help soften and break down decayed tissue without destroying the underlying healthy collagen fibers. | Other | Caries removal group |
| Riva Star Aqua, SDI Limited, AustraliaA solution that contains 44,800 ppm F and 253,870 ppm Ag. It acts as a fluoride storage for the acid challenges, while inhibites demineralization of hydroxyapatite crystals and preserves collagen from degradation in demineralized tissues. | Other | Caries arrest group |
Primary outcome
clinical success
Time frame: 6 and 12 month post-treatment
Presence/absence of: tooth pain, swelling, abscess, fistula, mobility, tenderness to percussion, tenderness to palpation.
radiographic success
Time frame: 12 month post-treatment
Presence/absence of: periapical pathology, pulp canal obliteration, root resorption, secondary caries formation.
2 secondary outcomes
Longevity and the quality of the final restoration
Time frame: 6 and 12 months post-treatment
Patient's acceptance
Time frame: immediately post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
Related trials for Caries,Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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.
Kyriaki Seremidi, Assist Prof contact
Sotiria Gizani, Assoc Prof principal investigator
Department Of Paediatric Dentistry, National And Kapodistrian University Of Athens
Questions about this trial
What is this clinical trial studying?
A study testing BRIX3000® and Riva Star Aqua, SDI Limited, Australia in people with Caries,Dental, run by National and Kapodistrian University of Athens.
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 1 inclusion and 1 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Sotiria Gizani, Assoc Prof (2107461233, sotiriagizani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical success (time frame: 6 and 12 month post-treatment). 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 29 Apr 2024.