Fissure Sealants for Caries Prevention in Children
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
Recruiting
N/AInterventional Study
Dental CariesFissure Sealant
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 12
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
University of Dublin, Trinity College · Other
Who this trial is looking for
This trial is looking for children aged 6 to 12 years old who need sealants on their first permanent molars. Participants will receive sealants either with or without an adhesive to see how well they work over two years.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 6 and 12 years old.
I need dental treatment at the Dublin Dental University Hospital.
I have my first permanent molars that are either caries-free or have early-stage caries.
My parents agree to let me take part.
You may not be able to join if
I have any developmental defects.
I have any type of restorative or sealant material in the tooth selected for the trial.
I have a significant dentine shadow or cavitation in the tooth.
I cannot cooperate for proper moisture control during the procedure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 cli…
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.
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Eligibility Criteria
Inclusion criteria:
1. 6 to 12 years of age;
2. Referred for dental treatment at the Dublin Dental University Hospital DDUH) or that are ongoing patients of the Paediatric dentistry clinic;
3. With first permanent molars that are caries free or present caries lesions restricted to enamel (ICDAS 1 t…
Inclusion criteria:
1. 6 to 12 years of age;
2. Referred for dental treatment at the Dublin Dental University Hospital DDUH) or that are ongoing patients of the Paediatric dentistry clinic;
3. With first permanent molars that are caries free or present caries lesions restricted to enamel (ICDAS 1 to 3) indicated for glass ionomer sealants.
4. Whose parents agreed and consent to participate in the present research;
Exclusion criteria:
1. Presence of any developmental defects
2. Presence of any type of restorative/sealant material in the selected tooth;
3. Presence of a dentine shadow (ICDAS 4) or dentine cavitation (ICDAS 5/6) detected clinically and/or radiographically14;
4. Insufficient cooperation to achieve adequate moisture control using cotton roll isolation
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