An interventional study of Non-restorative caries treatment (NRCT) and CT in Dental Caries and Primary Teeth, sponsored by Lenka Likar Ostrc, DMD. Active, not recruiting at 1 site in Slovenia. Open to participants aged 4 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Lenka Likar Ostrc, DMD · Not applicable, Interventional, and Treatment
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.
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.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's enrollment of 96 is above the median of 60 across 936 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
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.
Procedure: Non-restorative caries treatment (NRCT)
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.
Procedure: CT
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.
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.
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.
Time frame: Up to 5 years after treatment.
Oral hygiene
At each follow-up visit, the dentist re-evaluated the presence of plaque (OHI-S index).
Time frame: 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).
Time frame: 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.
Time frame: Immediately after treatment (Day 1).
Oral health related quality of life
Parents completed the ECOHIS-SVN questionnaire
Time frame: At scheduled follow-up visits from baseline through 5 years after treatment.
Plan to share: No
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Ran from Jan 2023 to primary completion in Oct 2023, 8 months.
Of 458 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's 8 months is below that.
Counting every sponsor, half of 486 studies reached it within 15 months; a quarter within 7 and three quarters within 31.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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