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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorTokat Gaziosmanpasa University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • application of deproteinization agents

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sodium Hypochlorite, WizardActive comparator 1 intervention
Group B: Hypochlorous Acid, SuperoxExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Edge Integrity Evaluation Criteria

Edge Integrity Evaluation Criteria 0 The fissure sealant and tooth surface are intact and cannot be distinguished with a probe. 1. The edges of the fissure sealants can be distinguished with a probe. 2. There is a gap along the edge of the fissure sealant and deep cracks reaching the central fossa.

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

Other outcomes

1

Marginal Coloration Evaluation Criteria

Marginal Coloration Evaluation Criteria 0 No color change between fissure sealant and tooth. 1. Color change in only one area. 2. Color change in many areas. 3. Severe color change indicating leakage.

Time frame
Following the sealant application, checks will be made at 6, 12, 24 and 36 months
2

Anatomical Form Evaluation Criteria

Anatomical Form Evaluation Criteria 0 Consistent with and continuous with occlusal form and structure. 1. Change in anatomical form but all pits and fissures covered. 2. a Partial loss of one or two pits or fissures but no need to repair or replace fissure sealant. 2b Partial loss of pits and fissures, fissure sealant needs to be replaced or repaired. 3 Loss of all pits and fissures. 7 Partial loss due to occlusion 9 Bleb not connected to margins

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

Sponsors and contacts

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