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

NCT ID: NCT02998814

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Fissure Sealant Loss Caries

Keywords

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fissure sealant etch and rinse self etch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

acid-etch

Intervention Type OTHER

acid-etch

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.

Group Type ACTIVE_COMPARATOR

self-etch adhesive

Intervention Type OTHER

Self etch (7th generation ) bonding agent

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.

Group Type ACTIVE_COMPARATOR

etch-and-rinse adhesive

Intervention Type OTHER

Total etch bonding agent (5th generation)

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.

Group Type ACTIVE_COMPARATOR

self-etch adhesive after acid-etch

Intervention Type OTHER

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

Interventions

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acid-etch

acid-etch

Intervention Type OTHER

self-etch adhesive

Self etch (7th generation ) bonding agent

Intervention Type OTHER

etch-and-rinse adhesive

Total etch bonding agent (5th generation)

Intervention Type OTHER

self-etch adhesive after acid-etch

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

Intervention Type OTHER

Other Intervention Names

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Adper Easy bond 3M ESPE Single BondTM, 3M ESPE acid etch + self-etch adhesive

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Bilge Kutuk

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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A.Ruya Yazici, DDS, PhD

Role: STUDY_DIRECTOR

Hacettepe University School of Dentistry

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/25864681?dopt=Abstract

pubmed

https://www.ncbi.nlm.nih.gov/pubmed/11145354?dopt=Abstract

pubmed

Other Identifiers

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HEK 10/13-9

Identifier Type: -

Identifier Source: org_study_id