The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars

Summary

Background: Resin-based fissure sealants (FS) are recommended to prevent pit-and-fissure caries development or prevent the progression of enamel caries lesion to frank cavitation into dentine. There is still limited clinical evidence on the use of adhesive system beneath fissure sealants in permanent molars and its effect on FS retention and caries progression.

Aim: The aim of this randomised clinical trial is to evaluate the clinical efficacy of fissure sealants placed with and without prior use of an adhesive system in terms of retention and caries prevention in permanent molars over the period of 2 years.

Study design: Children (6-12 years of age) with high caries risk that require sealants in their first permanent molars (ICDAS 0-3) will be selected at the Dublin Dental University Hospital (DDUH). Molars will be stratified according to presence of caries lesions (ICDAS 0 or ICDAS1-3) and randomly allocated according to the study groups (Test group: 17% phosphoric acid + adhesive system + FS; Control group: 17% phosphoric acid + FS). The randomisation unit will be the tooth and more than one tooth can be included per child. All children will be evaluated after 12 and 24 months by calibrated independent examiners. The primary outcome of the present trial is sealant retention over time. Clinical variables such as age, gender, tooth position (upper/lower), caries experience (DMFT/dmft), stage of eruption (erupted/partially erupted) and children's behavior (Frankl scale) will be collected.

Conditions

• Dental Caries
• Fissure Sealant

Interventions

PROCEDURE

Fissure sealant without adhesive system (NO BOND)

1. Cotton roll isolation 2. Etching of the enamel surface: 17% phosphoric 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO) 3. Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface. 4. Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip. 5. Lightcuring: The material will be lightcured for 20 seconds.

PROCEDURE

Fissure sealant with adhesive system (BOND)

1. Cotton roll isolation 2. Etching of the enamel surface: 17% phosphoric 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO) 3. Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface. 4. Adhesive system application: the adhesive system (Futurabond, VOCO) single dose capsule will be applied over the surface to be sealed for 5 seconds using a microbrush. The adhesive system will be air thin dried and lightcured for 10s before sealant placement. 5. Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip. 6. Lightcuring: The material will be lightcured for 20 seconds.

Sponsors & Collaborators

• University of Dublin, Trinity College

  lead OTHER

Principal Investigators

• Rona Leith · DDUH - Trinity College Dublin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-05

Primary Completion

2025-06-05

Completion

2027-06-05

Countries

• Ireland

Study Locations