NCT05475145: SealCar

Sealing of Occlusal Dentin Caries in Primary Molars.

Completed NA Last updated 26 July 2022

What this trial tests

NA trial testing Resin based sealing [RBS] in Caries; Dentin in 70 participants. Completed in 17 June 2022.

Timeline

2 February 2015

Primary endpoint
17 June 2021

17 June 2022

Quick facts

Lead sponsor	Mats Bågesund
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	2 February 2015
Primary completion	17 June 2021
Estimated completion	17 June 2022

Drugs / interventions tested

• Resin based sealing [RBS]

Conditions studied

• Caries; Dentin — all drugs for Caries; Dentin →
• Fissure, Dental — all drugs for Fissure, Dental →
• Dental Caries in Children — all drugs for Dental Caries in Children →
• Glass Ionomer Cement — all drugs for Glass Ionomer Cement →

Sponsor

Mats Bågesund

Who can join

Adults 3 to 9, any sex, with Caries; Dentin or Fissure, Dental. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BACKGROUND A simple method for arresting dentin caries with a tight seal of the cavity would exclude the need for injection and excavation, reduce the risk for dental fear and possibly postpone or eliminate the need for further treatment.

AIM The aim is to evaluate success-rate and children's subjective experience of resin-based sealing (RBS) and resin-modified glass ionomer cement (GIC) for treatment of occlusal dentin caries in primary molars.

DESIGN Children aged 2-9 years will be recruited to undergo RBS- or GIC-treatment treatment for occlusal dentin caries in primary molars. A parent will answer the Short Form of Children's Fear Survey (CFSS-DS; parental version). No excavation but etching with 38% phosphoric acid will precede RBS. Topical and local anaesthesia and excavation with high speed bur will precede GIC. Time for treatment will be estimated. The children will rank their experience of each treatment on a 7-grade face scale. The dentist will evaluate the child's experience, cooperation and the overall experience of the treatment on a four-grade scale. The treatment will be evaluated as "without remark" or "defective" after 3, 6, 12, 24 and 36 months. For statistical analysis the Chi-2-test, Wilcoxon-Signed-Rank-test and Paired t-test will be used.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Resin-based sealing vs resin-modified glass-ionomer filling for treatment of occlusal cavitated dentine caries lesions in primary molars - a multi-center randomized controlled split-mouth 3-year follow-up clinical trial.
   Bågesund M, Olson AC, Chizarie S, Omanovic M, et al · · 2026 · PMID 41520098 · DOI 10.1007/s40368-026-01161-7