Clinical trial NCT06771362: Evaluation of ART Restorations Using Two Different Bulk-Fill Restorative Materials in Primary Molars
Official title: Evaluation of ART Restorations Using Two Different Bulk-Fill Restorative Materials in Primary Molars With 12-month Follow-up According to Modified USPHS and Revised FDI Criteria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dentin Caries
Keywords: tooth demineralization
dental caries
Stomatognathic Diseases
Atraumatic Restorative Treatment
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to evaluate the success of two different bulk-fill restorative materials applied to teeth restored with atraumatic treatment at 3, 6, and 12-month follow-ups. The research seeks to address the following questions:

Which bulk-fill restorative material is more effective in terms of clinical success? How does the clinical success of bulk-fill restorations change over time (3, 6, and 12 months)? How do the two materials compare in terms of functional, aesthetic, and biological outcomes? To what extent does the cavity size of teeth with interproximal caries, restored using atraumatic treatment, influence treatment success? In this study, asymptomatic teeth with aproximal caries in children aged 4-9 will be repaired using atraumatic treatment and assessed based on the Modified USPHS (United States Public Health Service) and Revised FDI (World Dental Federation) criteria.

Detailed description: Atraumatic Restorative Treatment (ART) is a minimally invasive approach developed for treating dental caries. This method involves removing carious tissue to the minimum extent possible using hand instruments and restoring the cavity with a biocompatible material, such as high-viscosity glass ionomer cement (GIC). The fundamental principle of ART is to preserve the tooth's natural structure while providing a more comfortable and accessible treatment for patients. It offers a less stressful experience, particularly for children or patients with dental anxiety.

Patients between the ages of 4-9 who meet ICDAS II (International Caries Detection and Assessment System) 4-5-6 criteria and need restoration of asymptomatic primary molars with unilateral or multifaceted carious cavities will be included. Volunteers will be randomly divided into two groups, and the treatments of primary molars will be completed using two different high-viscosity glass ionamer cement (HV-GIC). The teeth in all groups will be cleaned of decay using an excavator down to the affected dentin. After the cavity is prepared, the tooth is isolated using cotton pellets.

Group 1: (RIVA Self Cure/HV, SDI, Australia) Apply a dentin conditioner (Riva Conditioner, SDI, Australia) to the prepared dentin surface for 10 seconds, then rinse thoroughly with water and gently blot dry. Ensure the tooth surface remains moist. The tooth will be restored with RIVA Self Cure (SDI, Australia) capsule form by the manufacturer's instructions, and the restoration will be covered with a sealing agent (RIVA Coat, SDI, Australia) Group 2: (STELA , SDI, Australia) STELA Primer (SDI, Australia) to the prepared cavity surface using a disposable brush applicator and leave it for 5 seconds. After drying the teeth, place the syringe into the mixer and follow the manufacturer's instructions for mixing. Apply the mixed STELA restorative material directly into the prepared cavity. The restoration is completed following the manufacturer's recommendations.

Before the procedure, demographic and dental data of the child volunteer, such as age, gender, brushing frequency, and number of teeth treated, will be recorded.

The US Public Health Service criteria (retention, anatomical form, surface roughness, secondary caries, marginal discoloration, and marginal integrity) and Modified FDI criteria will be used for clinical evaluation of restorations. The restorations will be evaluated clinically and radiologically at baseline 3., 6. and 12. months.

Eligibility criteria: Inclusion Criteria:

1. Patients and parents of the patients who accept to participate and sign the informed consent.
2. Children between the ages of 4-9
3. Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
4. Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS II index: code 4,5,6) affecting primary molars.
5. Absence of former history of spontaneous pain from the offending tooth/teeth.
6. Patients with an appropriate level of cooperation to complete treatment under clinical conditions.
7. Teeth are in a restorable condition. Natural exfoliation of primary teeth to be treated should not be expected within two years.

Exclusion Criteria:

1. Patients and parents of the patients who does not accept to participate and sign the informed consent
2. Patients with special health care needs or any medical conditions.
3. Primary molar teeth with excessive crown damage that cannot be restored.
4. Primary molar teeth in which bone loss exceeds 1/3 of the roots.
5. Primary molar teeth that have previously undergone root canal treatment or pulpotomy treatment.
6. Presence of internal/external and root resorption in primary teeth to be treated.
7. Root fracture, ankylosis or mobility in the primary teeth to be treated.

Primary outcomes:
measure: Change form 3 months to 12 months regarding
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Marginal adaptation"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Surface roughness"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Marginal staining"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Retention"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Incisal wear"
timeFrame: 3-month,6-month,12 month
measure: Functional properties according to revised FDI (World Dental Federation) criteria.
timeFrame: 3-month,6-month,12 month
measure: Biological properties according to revised FDI criteria
timeFrame: 3-month,6-month,12 month
measure: Aesthetic properties according to revised FDI criteria
timeFrame: 3-month,6-month,12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Çanakkale
country: Turkey
facility: Canakkale Onsekiz Mart University
state: Kepez
city: Çanakkale
country: Turkey
facility: Canakkale Onsekiz Mart University
state: Kepez
Study officials:
References: