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Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study

Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02998814
Enrollment
24
Registered
2016-12-20
Start date
2010-10-31
Completion date
2013-01-31
Last updated
2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries, Fissure Sealant Loss

Keywords

fissure sealant, etch and rinse, self etch

Brief summary

The purpose of this study was to evaluate the retention rates of a fissure sealant placed using different adhesive protocols over 24 months.Twenty-four subjects with no restoration and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a table of random numbers. Two other calibrated examiners, independently evaluated the sealants at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of caries formation being present or absent and retention using the following criteria: 1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to evaluate differences in retention rates among the sealants for each evaluation period.

Detailed description

Dental caries, which can be encountered by individuals throughout their lives, is one of the most chronic diseases worldwide. Researches have mainly been focusing on the prevention of tooth caries with the awareness of this fact. The use of fluorides as well as pit-and-fissure sealants are the most common preventive applications against caries progression.Modern adhesives combine conventional conditioning, priming and bonding steps (etch-and-rinse adhesives) together into one or two bottle (self-etch adhesives) to ease adhesive protocols. However, it is still suspicious whether modern self-etch adhesives have equal bonding capacity to the conventional etch-and-rinse systems. Therefore, clinical trials are necessary to evaluate long-term adhesive performance of self-etch adhesives compared to the conventional etch-and-rinse ones.

Interventions

OTHERacid-etch

acid-etch

Self etch (7th generation ) bonding agent

OTHERetch-and-rinse adhesive

Total etch bonding agent (5th generation)

OTHERself-etch adhesive after acid-etch

acid etch + self-etch adhesive Self etch (7th generation ) bonding agent

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 23 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients who participated in the current study had good general and oral health and hygiene. * with no detecatable caries, bruxism, malocclusion, previously placed restorations or sealants on the fissures, or no allergies to resins * willing to return for follow-up examinations

Exclusion criteria

* Third molars * Uncooperative patients * Molar teeth with antagonist tooth not present or extracted * Mentally and physically handicapped patients

Design outcomes

Primary

MeasureTime frameDescription
Changes in retention of sealants from baseline to two yearsat baseline and at 6-, 12-, 18-, and 24-monthThe assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every 6 month for 2 years.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026