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.
6 to 12 years of age;
Referred for dental treatment at the Dublin Dental University Hospital DDUH) or that are ongoing patients of the Paediatric dentistry clinic;
With first permanent molars that are caries free or present caries lesions restricted to enamel (ICDAS 1 to 3) indicated for glass ionomer sealants.
Whose parents agreed and consent to participate in the present research;
Presence of any developmental defects
Presence of any type of restorative/sealant material in the selected tooth;
Presence of a dentine shadow (ICDAS 4) or dentine cavitation (ICDAS 5/6) detected clinically and/or radiographically14;
Insufficient cooperation to achieve adequate moisture control using cotton roll isolation
Parallel
Fissure sealant without adhesive system (NO BOND)
Procedure/Surgery1. 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.
Fissure sealant with adhesive system (BOND)
Procedure/Surgery1. 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.
Sealant Retention
Sealant retention will be examined after 1 and 2 years by a trained, calibrated, independent examiner. Sealant retention (secondary outcome) will be evaluated according to the scoring system proposed by Oba et al. 2009: 0 (fully retained sealant); 1 (partially retained sealant) or 2 (absent sealant). Early failures will be identified and recorded in the patient's review appointment in the undergraduate clinic.
Caries Progression
Caries progression will be examined after 1 and 2 years by a trained, calibrated, independent examiner according to ICDAS criteria (Ismail et al., 2006). Presence of caries progression will be scored if progression into dentine is seen (ICDAS 4-6).
Patient behaviour
Patient's behaviour during the treatment will be reported by the operator at the end of the procedure using Frankl's behavior rating scale.
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