Dental CariesNRCTNCT07866755
Non-Restorative Versus Conventional Caries Treatment in Primary Teeth: A Randomized Controlled Trial
A study testing Non-restorative caries treatment (NRCT) and CT in people with Dental Caries and Primary Teeth, run by Lenka Likar Ostrc, DMD at 1 site in Slovenia.
Trial summary
Dental caries is common in young children, and treatment of cavities in primary teeth can be challenging. Conventional treatment usually involves removal of carious tooth tissue and placement of a restoration. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Dental Caries, Primary Teeth
- What is being tested?
- Non-restorative caries treatment (NRCT) and CT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSlovenia
- Study dates
- 21 Jan 2023to Oct 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 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child willing to participate in the study
- Presence of a cavitated carious lesion involving one or a maximum of two tooth surfaces
- Carious lesion extending radiographically no deeper than the middle third of dentine
- Carious lesion not extending below the free gingival margin
- Affected tooth asymptomatic, with no current discomfort or pain
- No previous symptoms associated with the affected tooth
- No clinical or radiographic signs or symptoms suggestive of pulpal or periodontal disease
- Affected tooth free of developmental defects of the dental hard tissues
Who cannot join
- Presence of a systemic disease or syndrome
- Previous trauma to the head and neck region
- Previous surgery in the head and neck region
- Previous radiotherapy to the head and neck region
- Physical, cognitive, or language impairment that could interfere with participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Patient-Reported Outcomes of Non-Restorative Versus Conventional Caries Treatment in Primary Teeth: A Randomized Controlled Trial
Dental caries is common in young children, and treatment of cavities in primary teeth can be challenging. Conventional treatment usually involves removal of carious tooth tissue and placement of a restoration. In young children, however, this approach may be associated with discomfort, the need for local anaesthesia, and difficulties with cooperation. Minimally invasive approaches have therefore been developed to control caries while reducing the burden of treatment.
The main goal of this study is to evaluate whether minimally invasive approaches for treating cavitated carious lesions in primary molars are clinically effective and acceptable to young children. The study also examines whether the type of treatment influences children's cooperation and discomfort during dental care, oral health-related quality of life, and treatment costs.
Read more
The main research questions are whether minimally invasive treatments can provide clinical outcomes comparable with conventional restorative treatment, whether children cooperate better or experience less discomfort during minimally invasive treatment, and whether the different treatment approaches have different effects on oral health-related quality of life and treatment costs.
Children aged 3 to 6 years attending selected public kindergartens are invited to participate. Children who meet the study criteria undergo a dental examination and, when indicated, radiographic assessment of the carious lesion. Eligible children are then randomly assigned to one of three treatment groups.
In the conventional treatment group, carious tooth tissue is removed and the tooth is restored with a filling. In the selective caries removal group, only part of the carious dentine is removed before the cavity is restored. In the non-restorative caries treatment group, or NRCT, no conventional restoration is placed; instead, the cavity is made accessible for cleaning when necessary, fluoride varnish is applied, and children and parents receive instructions on oral hygiene and diet.
After treatment, children's cooperation and perceived discomfort are assessed. During follow-up visits, the researchers evaluate oral hygiene, the condition of the treated teeth, progression of caries, and possible treatment-related complications. Parents also complete questionnaires assessing the child's oral health-related quality of life.
The study is designed to determine whether less invasive treatment approaches can offer a safe, effective, and child-friendly alternative to conventional restorative treatment of caries in primary teeth. The findings may contribute to future recommendations and clinical guidelines for the management of cavitated carious lesions in children.
Read the detailed description
This prospective randomized clinical study was designed to compare conventional and minimally invasive approaches for the management of cavitated dentinal carious lesions in primary molars in young children. The study also evaluates the feasibility of incorporating less invasive caries management strategies into paediatric dental care and follows treated teeth over time to assess the clinical course of the lesions and treatment-related events. The study protocol is based on contemporary concepts of caries management, according to which control of the cariogenic biofilm and preservation of tooth vitality are central to successful management of dentinal carious lesions.
Children attending selected public kindergartens are invited to participate. Following informed parental consent, an initial dental examination is performed. Children presenting with primary molars affected by cavitated dentinal carious lesions and meeting the study requirements are invited for further assessment in the dental clinic. Clinical assessment includes evaluation of caries using the International Caries Detection and Assessment System (ICDAS II), assessment of oral hygiene using the Simplified Oral Hygiene Index (OHI-S), and assessment of gingival status. Radiographic examination of the affected primary molars is performed when indicated to supplement the clinical diagnosis and to assess lesion depth before treatment.
The study population is randomly allocated by computer-generated randomization to three treatment groups. The three treatment approaches represent different levels of invasiveness in the management of cavitated dentinal caries in primary molars.
In the conventional treatment group, carious tissue is removed according to the traditional restorative approach and the cavity is restored with a compomer restorative material. Preventive measures include oral hygiene instruction, dietary counselling, and application of fluoride varnish.
In the selective caries removal group, carious tissue is removed selectively. Carious dentine is removed from the cavity walls, while a portion of softer dentine is intentionally retained in deeper areas in order to avoid unnecessary removal of dentine and reduce the risk of pulpal exposure. The cavity is subsequently sealed with a restorative material. Children and their parents or caregivers also receive oral hygiene and dietary instructions, and fluoride varnish is applied.
In the non-restorative caries treatment (NRCT) group, conventional cavity preparation and placement of a restoration are avoided. Unsupported enamel may be removed when necessary to make the lesion accessible for cleaning. Fluoride varnish is applied to the lesion, and particular emphasis is placed on regular and effective plaque removal from the cavitated surface. Parents or caregivers and children receive individualized instructions on oral hygiene and diet. The biological principle of NRCT is that caries activity can be controlled by disruption of the cariogenic biofilm and maintenance of a cleansable lesion rather than by complete removal of all carious tissue.
After treatment, the child's response to the dental procedure is recorded using established behavioural and pain-assessment instruments. Parents or caregivers also provide information related to the child's oral health and treatment experience.
Participants are followed longitudinally. Follow-up schedules differ according to treatment strategy, with children receiving NRCT monitored more frequently during the early phase of treatment because successful non-restorative management depends on maintaining adequate plaque control and demonstrating clinical arrest of the lesion. Children receiving restorative treatment are reviewed at longer intervals. At follow-up visits, oral hygiene and the clinical condition of the treated teeth are reassessed, and treatment-related complications or progression of caries are documented.
Fluoride varnish is reapplied periodically according to treatment group. Children whose oral hygiene is inadequate receive additional oral hygiene and dietary counselling. In the NRCT group, treatment is discontinued and conventional restorative management is provided if adequate plaque control cannot be achieved, if the lesion progresses, or if continued participation in the non-restorative treatment protocol is considered clinically inappropriate. This safety approach is intended to ensure that children do not remain in a minimally invasive treatment pathway when disease control is unsuccessful.
Radiographic reassessment is not performed routinely at every follow-up visit. It is undertaken individually when clinical findings suggest possible progression of the carious process or another indication for radiographic evaluation. This approach is intended to limit unnecessary radiation exposure while allowing radiographic assessment when clinically justified.
The study includes evaluation of patient-centred aspects of treatment in addition to clinical performance. Oral health-related quality of life is assessed using the Early Childhood Oral Health Impact Scale (ECOHIS), and parents or caregivers provide information on oral hygiene and dietary habits. The broader objective is to evaluate treatment approaches not only according to clinical effectiveness but also according to their acceptability to children and families and their potential influence on the child's experience of dental care.
The economic component of the study considers resources associated with each treatment approach, including professional time, dental staff time, materials used, and additional treatment required in the event of complications or deterioration of the treated tooth.
The planned active study period is 36 months, after which treated primary teeth may continue to be observed until physiological exfoliation. The longer-term follow-up is intended to provide information on the clinical course of treated primary molars beyond the initial treatment period.
The study was developed to provide evidence on the effectiveness and practical applicability of minimally invasive caries management in primary teeth and to support future clinical recommendations for the management of cavitated dentinal carious lesions in children.
- Conditions
- Dental Caries, Primary Teeth
- Being tested
- Non-restorative caries treatment (NRCT), CT
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-restorative caries treatment (NRCT)Procedure or surgery
NRCT group - Non-restorative caries treatment (NRCT):
Overhanging enamel, when present, was removed to improve access for cleaning. Fluoride varnish was applied to the cavitated lesion and the remaining dentition. Children and parents received dietary and oral hygiene instructions, with particular emphasis on effective cleaning of the cavitated lesion.
CT group - Conventional restorative treatment (CT):
Carious tissue was removed and the tooth was restored with a compomer restoration. Local anaesthesia was used when required. Fluoride varnish was applied to the dentition, and children and parents received dietary and oral hygiene instructions.
CTProcedure or surgery
CT group - Conventional restorative treatment (CT):
Carious tissue was removed and the tooth was restored with a compomer restoration. Local anaesthesia was used when required. Fluoride varnish was applied to the dentition, and children and parents received dietary and oral hygiene instructions.
| Study group | Role | What they receive |
|---|---|---|
| NRCT | Experimental | In the NRCT group, overhanging enamel, if present, was removed using a diamond bur and a high-speed dental handpiece. In no case was local anaesthesia required for this procedure. Fluoride varnish (Fluor Protector, Ivoclar Vivadent, Schaan, Liechtenstein) was then applied to the cavity and to the remaining dental crowns. The child and parent received thorough instruction on a non-cariogenic diet and oral hygiene, with special emphasis on proper cleaning of the cavitated lesion. Receives: Procedure: Non-restorative caries treatment (NRCT) |
| CT | Active comparator | In the CT control group, carious tissue was removed and the tooth was restored using a compomer material (Dyract, Dentsply, Konstanz, Germany). Local anaesthesia was administered when required. As in the NRCT group, fluoride varnish (Fluor Protector, Ivoclar Vivadent, Schaan, Liechtenstein) was applied to the dentition, and the child and parent received detailed dietary and oral hygiene instructions. Receives: Procedure: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical effectiveness of NRCT compared with CT in arresting dentine caries lesions
At each follow-up visit, the dentist re-evaluated the treated lesions according to ICDAS criteria and recorded any minor or major treatment failures.
Measured: Up to 5 years after treatment.
Secondary outcomes (4)
Oral hygiene
At each follow-up visit, the dentist re-evaluated the presence of plaque (OHI-S index).
Measured: At scheduled follow-up visits from baseline through 5 years after treatment.
Child's perceived pain
At the conclusion of the treatment, each child participating in the study reported their perceived pain during the treatment using the Visual Analog Scale of Faces (VASOF).
Measured: Immediately after treatment (Day 1).
The child's behaviour during the treatment procedure
The child's behaviour during the treatment procedure was assessed by the dentist using Frankl's behaviour rating scale.
Measured: Immediately after treatment (Day 1).
Oral health related quality of life
Parents completed the ECOHIS-SVN questionnaire
Measured: At scheduled follow-up visits from baseline through 5 years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start21 Jan 2023
- Primary completion20 Oct 2023
- Study completionOct 2028 (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
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lenka Likar Ostrc, DMD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lenka Likar Ostrc, DMD, University of Ljubljana, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866755
- Sponsor's protocol ID
- 0120-484/2019/11
- Acronym
- NRCT
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Patient-Reported Outcomes of Non-Restorative Versus Conventional Caries Treatment in Primary Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07866755
- Acronym / sponsor ID
- NRCT / 0120-484/2019/11
- Conditions
- Dental Caries, Primary Teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Lenka Likar Ostrc, DMDUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Oct 2026 (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.
Dental caries is common in young children, and treatment of cavities in primary teeth can be challenging. Conventional treatment usually involves removal of carious tooth tissue and placement of a restoration. In young children, however, this approach may be associated with discomfort, the need for local anaesthesia, and difficulties with cooperation. Minimally invasive approaches have therefore been developed to control caries while reducing the burden of treatment.
The main goal of this study is to evaluate whether minimally invasive approaches for treating cavitated carious lesions in primary molars are clinically effective and acceptable to young children. The study also examines whether the type of treatment influences children's cooperation and discomfort during dental care, oral health-related quality of life, and treatment costs.
The main research questions are whether minimally invasive treatments can provide clinical outcomes comparable with conventional restorative treatment, whether children cooperate better or experience less discomfort during minimally invasive treatment, and whether the different treatment approaches have different effects on oral health-related quality of life and treatment costs.
Children aged 3 to 6 years attending selected public kindergartens are invited to participate. Children who meet the study criteria undergo a dental examination and, when indicated, radiographic assessment of the carious lesion. Eligible children are then randomly assigned to one of three treatment groups.
In the conventional treatment group, carious tooth tissue is removed and the tooth is restored with a filling. In the selective caries removal group, only part of the carious dentine is removed before the cavity is restored. In the non-restorative caries treatment group, or NRCT, no conventional restoration is placed; instead, the cavity is made accessible for cleaning when necessary, fluoride varnish is applied, and children and parents receive instructions on oral hygiene and diet.
After treatment, children's cooperation and perceived discomfort are assessed. During follow-up visits, the researchers evaluate oral hygiene, the condition of the treated teeth, progression of caries, and possible treatment-related complications. Parents also complete questionnaires assessing the child's oral health-related quality of life.
The study is designed to determine whether less invasive treatment approaches can offer a safe, effective, and child-friendly alternative to conventional restorative treatment of caries in primary teeth. The findings may contribute to future recommendations and clinical guidelines for the management of cavitated carious lesions in children.
Detailed description
This prospective randomized clinical study was designed to compare conventional and minimally invasive approaches for the management of cavitated dentinal carious lesions in primary molars in young children. The study also evaluates the feasibility of incorporating less invasive caries management strategies into paediatric dental care and follows treated teeth over time to assess the clinical course of the lesions and treatment-related events. The study protocol is based on contemporary concepts of caries management, according to which control of the cariogenic biofilm and preservation of tooth vitality are central to successful management of dentinal carious lesions.
Children attending selected public kindergartens are invited to participate. Following informed parental consent, an initial dental examination is performed. Children presenting with primary molars affected by cavitated dentinal carious lesions and meeting the study requirements are invited for further assessment in the dental clinic. Clinical assessment includes evaluation of caries using the International Caries Detection and Assessment System (ICDAS II), assessment of oral hygiene using the Simplified Oral Hygiene Index (OHI-S), and assessment of gingival status. Radiographic examination of the affected primary molars is performed when indicated to supplement the clinical diagnosis and to assess lesion depth before treatment.
The study population is randomly allocated by computer-generated randomization to three treatment groups. The three treatment approaches represent different levels of invasiveness in the management of cavitated dentinal caries in primary molars.
In the conventional treatment group, carious tissue is removed according to the traditional restorative approach and the cavity is restored with a compomer restorative material. Preventive measures include oral hygiene instruction, dietary counselling, and application of fluoride varnish.
In the selective caries removal group, carious tissue is removed selectively. Carious dentine is removed from the cavity walls, while a portion of softer dentine is intentionally retained in deeper areas in order to avoid unnecessary removal of dentine and reduce the risk of pulpal exposure. The cavity is subsequently sealed with a restorative material. Children and their parents or caregivers also receive oral hygiene and dietary instructions, and fluoride varnish is applied.
In the non-restorative caries treatment (NRCT) group, conventional cavity preparation and placement of a restoration are avoided. Unsupported enamel may be removed when necessary to make the lesion accessible for cleaning. Fluoride varnish is applied to the lesion, and particular emphasis is placed on regular and effective plaque removal from the cavitated surface. Parents or caregivers and children receive individualized instructions on oral hygiene and diet. The biological principle of NRCT is that caries activity can be controlled by disruption of the cariogenic biofilm and maintenance of a cleansable lesion rather than by complete removal of all carious tissue.
After treatment, the child's response to the dental procedure is recorded using established behavioural and pain-assessment instruments. Parents or caregivers also provide information related to the child's oral health and treatment experience.
Participants are followed longitudinally. Follow-up schedules differ according to treatment strategy, with children receiving NRCT monitored more frequently during the early phase of treatment because successful non-restorative management depends on maintaining adequate plaque control and demonstrating clinical arrest of the lesion. Children receiving restorative treatment are reviewed at longer intervals. At follow-up visits, oral hygiene and the clinical condition of the treated teeth are reassessed, and treatment-related complications or progression of caries are documented.
Fluoride varnish is reapplied periodically according to treatment group. Children whose oral hygiene is inadequate receive additional oral hygiene and dietary counselling. In the NRCT group, treatment is discontinued and conventional restorative management is provided if adequate plaque control cannot be achieved, if the lesion progresses, or if continued participation in the non-restorative treatment protocol is considered clinically inappropriate. This safety approach is intended to ensure that children do not remain in a minimally invasive treatment pathway when disease control is unsuccessful.
Radiographic reassessment is not performed routinely at every follow-up visit. It is undertaken individually when clinical findings suggest possible progression of the carious process or another indication for radiographic evaluation. This approach is intended to limit unnecessary radiation exposure while allowing radiographic assessment when clinically justified.
The study includes evaluation of patient-centred aspects of treatment in addition to clinical performance. Oral health-related quality of life is assessed using the Early Childhood Oral Health Impact Scale (ECOHIS), and parents or caregivers provide information on oral hygiene and dietary habits. The broader objective is to evaluate treatment approaches not only according to clinical effectiveness but also according to their acceptability to children and families and their potential influence on the child's experience of dental care.
The economic component of the study considers resources associated with each treatment approach, including professional time, dental staff time, materials used, and additional treatment required in the event of complications or deterioration of the treated tooth.
The planned active study period is 36 months, after which treated primary teeth may continue to be observed until physiological exfoliation. The longer-term follow-up is intended to provide information on the clinical course of treated primary molars beyond the initial treatment period.
The study was developed to provide evidence on the effectiveness and practical applicability of minimally invasive caries management in primary teeth and to support future clinical recommendations for the management of cavitated dentinal carious lesions in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NRCT | Experimental | Procedure: Non-restorative caries treatment (NRCT)In the NRCT group, overhanging enamel, if present, was removed using a diamond bur and a high-speed dental handpiece. In no case was local anaesthesia required for this procedure. Fluoride varnish (Fluor Protector, Ivoclar Vivadent, Schaan, Liechtenstein) was then applied to the cavity and to the remaining dental crowns. The child and parent received thorough instruction on a non-cariogenic diet and oral hygiene, with special emphasis on proper cleaning of the cavitated lesion. |
| CT | Active comparator | Procedure: CTIn the CT control group, carious tissue was removed and the tooth was restored using a compomer material (Dyract, Dentsply, Konstanz, Germany). Local anaesthesia was administered when required. As in the NRCT group, fluoride varnish (Fluor Protector, Ivoclar Vivadent, Schaan, Liechtenstein) was applied to the dentition, and the child and parent received detailed dietary and oral hygiene instructions. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child willing to participate in the study
- Presence of a cavitated carious lesion involving one or a maximum of two tooth surfaces
- Carious lesion extending radiographically no deeper than the middle third of dentine
- Carious lesion not extending below the free gingival margin
- Affected tooth asymptomatic, with no current discomfort or pain
Key exclusion criteria (5 listed)
- Presence of a systemic disease or syndrome
- Previous trauma to the head and neck region
- Previous surgery in the head and neck region
- Previous radiotherapy to the head and neck region
- Physical, cognitive, or language impairment that could interfere with participation in the study
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 |
|---|---|---|
| Non-restorative caries treatment (NRCT)NRCT group - Non-restorative caries treatment (NRCT): Overhanging enamel, when present, was removed to improve access for cleaning. Fluoride varnish was applied to the cavitated lesion and the remaining dentition. Children and parents received dietary and oral hygiene instructions, with particular emphasis on effective cleaning of the cavitated lesion. CT group - Conventional restorative treatment (CT): Carious tissue was removed and the tooth was restored with a compomer restoration. Local anaesthesia was used when required. Fluoride varnish was applied to the dentition, and children and parents received dietary and oral hygiene instructions. | Procedure or surgery | NRCT |
| CTCT group - Conventional restorative treatment (CT): Carious tissue was removed and the tooth was restored with a compomer restoration. Local anaesthesia was used when required. Fluoride varnish was applied to the dentition, and children and parents received dietary and oral hygiene instructions. | Procedure or surgery | CT |
Primary outcome
clinical effectiveness of NRCT compared with CT in arresting dentine caries lesions
Time frame: Up to 5 years after treatment.
At each follow-up visit, the dentist re-evaluated the treated lesions according to ICDAS criteria and recorded any minor or major treatment failures.
4 secondary outcomes
Oral hygiene
Time frame: At scheduled follow-up visits from baseline through 5 years after treatment.
Child's perceived pain
Time frame: Immediately after treatment (Day 1).
The child's behaviour during the treatment procedure
Time frame: Immediately after treatment (Day 1).
Oral health related quality of life
Time frame: At scheduled follow-up visits from baseline through 5 years after treatment.
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 8 Oct 2026.
- 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.
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 Non-restorative caries treatment (NRCT) and CT in people with Dental Caries and Primary Teeth, run by Lenka Likar Ostrc, DMD at 1 site in Slovenia.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. 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 Slovenia. 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?
clinical effectiveness of NRCT compared with CT in arresting dentine caries lesions (time frame: Up to 5 years after treatment.). 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 8 Oct 2026.