The Effect of Different Deproteinising Agents on the Clinical Success of Fissure Sealants in Permanent Teeth

NCT06988098 | Recruiting

• 1 other identifier: 23-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fissure Sealant

Keywords

Deproteinization Agents; Sodium Hypochlorite; Hypochlorous Acid; fissure sealent

Outcome Measures

Primary Outcomes (1)

• Modified Simonsen Criteria

  Modified Simonsen Criteria Score 0 Fissure sealant is completely in the mouth and there is no new caries. Score 1 Partial loss of fissure sealant, no new caries. Score 2 Partial loss of fissure sealant and new caries. Score 3 Complete loss of fissure sealant, no new caries. Score 4 Complete loss of fissure sealant and new caries.

  Following the sealant application, controls will be made at 6, 12, 24 and 36 months.

Secondary Outcomes (1)

• Edge Integrity Evaluation Criteria

  Following the sealant application, controls will be made at 6, 12, 24 and 36 months.

Other Outcomes (2)

• Marginal Coloration Evaluation Criteria

  Following the sealant application, checks will be made at 6, 12, 24 and 36 months

• Anatomical Form Evaluation Criteria

  Following the sealant application, checks will be made at 6, 12, 24 and 36 months

Study Arms (2)

Sodium Hypochlorite, Wizard

ACTIVE COMPARATOR

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.

Other: application of deproteinization agents

Hypochlorous Acid, Superox

EXPERIMENTAL

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 rang

Other: application of deproteinization agents

Interventions

application of deproteinization agents 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; Sodium Hypochlorite, Wizard

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients between the ages of 6-9 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 newly erupted permanent lower first molars without caries
• Have an indication for fissure sealant application

You may not qualify if:

• Teeth with fissure sealants
• Teeth with developmental defects such as hypoplasia
• Teeth with approximal or incipient caries lesions on one or both mandibular first permanent molars
• Children who are not systemically healthy
• Uncooperative children with scores of 1 and 2 on the Frankl Behavior Scale
• Children and parents who refuse to attend follow-up appointments
• Children with parafunctional habits such as teeth grinding

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, 60030, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 11145354 RESULT

• 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.

  PMID: 1835987 RESULT

Central Study Contacts

Alem Coşgun

CONTACT

+905524133222; alemcosgun@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant proffessor

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 23, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)