The Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth

NCT ID: NCT07003958

Last Updated: 2025-06-04

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2026-08-05

Brief Summary

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Investigation of the effect of deproteinization agents on the clinical success of non-invasive fissure sealant application, which is a non-invasive method used to prevent caries formation or to stop the progression of initial caries lesions limited to enamel on tooth surfaces thought to be at high risk of caries.

Detailed Description

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Conditions

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Fissure Sealant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Sodium Hypochlorite, Wizard

There are many studies in the literature showing that the use of 5.25% NaOCl as an enamel deproteinization agent is successful in positively affecting adhesion by removing organic elements from both the enamel structure and the pellicle on the enamel surface before acid application. However, sodium hypochlorite is a strong oxidizing agent and has disadvantages such as the risk of reaction in the soft tissues of the mouth, bad odor and bad taste, especially if not used carefully in pediatric dentistry, which has led to the search for an alternative material.

Group Type ACTIVE_COMPARATOR

application of deproteinization agents

Intervention Type OTHER

Since there is no in vivo study in the literature evaluating the clinical success of the use of hypochlorous acid for deproteinization in fissure sealants, our planned study is the first in this regard.

Hypochlorous Acid, Superox

Hypochlorous acid is produced by the body's immune system cells, neutrophilic polymorphonuclear leukocytes, as a result of oxidative reactions to overcome pathogenic microorganisms and fight infection. Recently, slightly acidic HOCl solutions, developed by electrolysis of NaOCl, have been widely used as disinfectants. Hypochlorous acid has been shown to significantly reduce the lipopolysaccharide concentration of Porphyromonas gingivalis compared to NaOCl and chlorhexidine and to be an agent tolerated by oral tissues. It has also been reported that HOCl used as a mouthwash does not produce any systemic side effects. In clinical dentistry, HOCl has been shown to be highly effective as a result of its antimicrobial and deproteinizing properties. HOCl, with its low acidity, is an antiseptic irrigant with extraordinary properties, not only exhibiting biocompatibility and low cytotoxicity, but also having rapid and highly effective antimicrobial activity in physiological concentration ran

Group Type EXPERIMENTAL

application of deproteinization agents

Intervention Type OTHER

Since there is no in vivo study in the literature evaluating the clinical success of the use of hypochlorous acid for deproteinization in fissure sealants, our planned study is the first in this regard.

Interventions

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application of deproteinization agents

Since there is no in vivo study in the literature evaluating the clinical success of the use of hypochlorous acid for deproteinization in fissure sealants, our planned study is the first in this regard.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 4-6 who do not have any systemic problems
* Have a score of 3 and 4 on the Frankl Behavior Scale
* Do not have a habit of clenching and/or grinding their teeth
* Have lower second primary molars without caries
* Have an indication for fissure sealant application

Exclusion Criteria

* Teeth with fissure sealants
* Teeth with developmental defects such as hypoplasia
* Teeth with approximal or incipient caries lesions on one or both mandibular second primary molars
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Alem Coşgun

Assistant proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tokat Gaziosmanpaşa University, Tokat, 60030

Tokat Province, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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alem coşgun

Role: CONTACT

+905524133222

Facility Contacts

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alem coşgun

Role: primary

05524133222

References

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Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601.

Reference Type RESULT
PMID: 11145354 (View on PubMed)

Simonsen RJ. Retention and effectiveness of dental sealant after 15 years. J Am Dent Assoc. 1991 Oct;122(10):34-42. doi: 10.14219/jada.archive.1991.0289.

Reference Type RESULT
PMID: 1835987 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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23-18

Identifier Type: -

Identifier Source: org_study_id

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