Sealing of Occlusal Dentin Caries in Primary Molars.

NCT05475145 | Completed DMC

• 4 other identifiers: 2014/297-31#7-15-19, #7-16-7SPF2018#565531, #666761, #862781
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Caries; Dentin; Fissure, Dental; Dental Caries in Children; Glass Ionomer Cement; Fissure Sealants

Keywords

fissure sealant; dental atraumatic restorative treatment; deciduous teeth; glass ionomer cement; Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• Treatment success without defects after 3 years

  Percentage of treatments (for each of the studied groups) without defects during the 3-year follow up period

  3 years. Evaluation will be performed at each follow up visit - that is after 3 months, 6 months, 12 months ´, 24 months and after 36 months. Registration of possiblöe defects will be performed atv ech visit for each patient for each of the used methods.

Secondary Outcomes (3)

• Patient preferance

  3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.

• Dentist´s preferance

  3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.

• Time used for the treatment

  3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.

Study Arms (1)

Child

EXPERIMENTAL

Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing \[RBS\] or Glassionomer cement \[GIC\].

Procedure: Resin based sealing [RBS]

Interventions

Resin based sealing [RBS] PROCEDURE

Also known as: Glassionomer cement [GIC].

Child

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• primary occlusal dentin caries in two primary molars

You may not qualify if:

• Language problems or disabilities
• Less than 3 years until expected exfoliation
• Hypomineralization
• Previous filling or dentin caries
• Carious cavity \>1/3 of occlusal surface
• Unable to cooperate
• Appearing caries or filling (on studied tooth) not originating from the studied cavity
• Tooth exfoliating before end of study
• Leaving Public dental service or moving out of the region during follow up period

Sponsors & Collaborators

• Mats Bågesund: lead
• Linkoeping University: collaborator

Related Publications (1)

• Bagesund M, Olson AC, Chizarie S, Omanovic M, Zuber A, Hultquist AI. 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. Eur Arch Paediatr Dent. 2026 Jan 10. doi: 10.1007/s40368-026-01161-7. Online ahead of print.

  PMID: 41520098 DERIVED

MeSH Terms

Conditions

Dental Fissures

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mats A Bågesund, PhD,AssProf

  Linkoeping University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: We consider it not possible to mask för participant or care provider.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Assistant Professor, Senior Consultant Specialist in Pediatric Dentistry

Model Details: Non-blinded randomized split-mouth longitudinal 3 year follow up study.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 26, 2022
• Study Start: February 2, 2015
• Primary Completion: June 17, 2021
• Study Completion: June 17, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share