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

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.

Study Overview

• Status: Completed
• Conditions: Caries; Fissure Sealant Loss
• Intervention / Treatment: Other: acid-etch; Other: self-etch adhesive; Other: etch-and-rinse adhesive; Other: self-etch adhesive after acid-etch

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 23 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: acid-etch only; Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for acid-etch only will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.	Other: acid-etch; acid-etch
Active Comparator: self-etch adhesive; Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for self-etch adhesive will be treated with self-etch adhesive (AdperTM EasyBond, 3M ESPE) for 10 seconds followed by light curing for 20 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.	Other: self-etch adhesive; Self etch (7th generation ) bonding agent; Other Names: Adper Easy bond 3M ESPE
Active Comparator: etch-and-rinse adhesive; Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch-and-rinse adhesive will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Then, etch-and-rinse adhesive (Single BondTM, 3M ESPE) will be treated with for 10 seconds followed by light curing for 20 seconds.Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.	Other: etch-and-rinse adhesive; Total etch bonding agent (5th generation); Other Names: Single BondTM, 3M ESPE
Active Comparator: self-etch adhesive after acid-etch; Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for acid etch + self-etch adhesive will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Then, self-etch adhesive (AdperTM EasyBond, 3M ESPE) will be treated with for 10 seconds followed by light curing for 20 seconds.Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.	Other: self-etch adhesive after acid-etch; acid etch + self-etch adhesive Self etch (7th generation ) bonding agent; Other Names: acid etch + self-etch adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: A.Ruya Yazici, DDS, PhD, Hacettepe University School of Dentistry

Publications and helpful links

Helpful Links

• pubmed
• pubmed

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: fissure sealant; self etch; etch and rinse
• Other Study ID Numbers: HEK 10/13-9