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

NCT02998814 | Completed DMC

• 1 other identifier: HEK 10/13-9
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Fissure Sealant Loss; Caries

Keywords

fissure sealant; etch and rinse; self etch

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

acid-etch only

ACTIVE COMPARATOR

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

self-etch adhesive

ACTIVE COMPARATOR

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

etch-and-rinse adhesive

ACTIVE COMPARATOR

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

self-etch adhesive after acid-etch

ACTIVE COMPARATOR

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

Interventions

acid-etch OTHER

acid-etch

acid-etch only

self-etch adhesive OTHER

Self etch (7th generation ) bonding agent

Also known as: Adper Easy bond 3M ESPE

self-etch adhesive

etch-and-rinse adhesive OTHER

Total etch bonding agent (5th generation)

Also known as: Single BondTM, 3M ESPE

etch-and-rinse adhesive

self-etch adhesive after acid-etch OTHER

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

Also known as: acid etch + self-etch adhesive

self-etch adhesive after acid-etch

Eligibility Criteria

• Age: 20 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Links

• pubmed
• pubmed

Study Officials

• A.Ruya Yazici, DDS, PhD

  Hacettepe University School of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

TU (1)