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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998814
• Other study ID #: HEK 10/13-9
• Status: Completed
• Phase: N/A
• First received: December 16, 2016
• Last updated: December 16, 2016
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: December 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 23 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caries
• Fissure Sealant Loss

Intervention

Other:
• acid-etch
acid-etch
• self-etch adhesive
Self etch (7th generation ) bonding agent
• etch-and-rinse adhesive
Total etch bonding agent (5th generation)
• self-etch adhesive after acid-etch
acid etch + self-etch adhesive Self etch (7th generation ) bonding agent

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in retention of sealants from baseline to two years	The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every 6 month for 2 years.	at baseline and at 6-, 12-, 18-, and 24-month	Yes

External Links

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