Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Permanent Teeth: Splint Mouth Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Modified Simonsen Criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
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 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
Arms & Interventions
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.
Intervention: application of deproteinization agents (Other)
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 rang
Intervention: application of deproteinization agents (Other)
Outcomes
Primary Outcomes
Modified Simonsen Criteria
Time Frame: Following the sealant application, controls will be made at 6, 12, 24 and 36 months.
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.
Secondary Outcomes
- Edge Integrity Evaluation Criteria(Following the sealant application, controls will be made at 6, 12, 24 and 36 months.)
Investigators
Alem Coşgun
Asistant proffessor
Tokat Gaziosmanpasa University
