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

Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth: Splint Mouth Clinical Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07003958
Enrollment
60
Registered
2025-06-04
Start date
2024-08-05
Completion date
2026-08-05
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fissure Sealant

Keywords

deproteinization agents, sodium hypochlorite, hypochlorous acid, fissure sealent, Primary Teeth

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.

Interventions

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.

Sponsors

Tokat Gaziosmanpasa University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Simonsen CriteriaFollowing the sealant application, controls will be made at 3,6, 12 and 24 monthsModified 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

MeasureTime frameDescription
Edge Integrity Evaluation CriteriaFollowing the sealant application, controls will be made at 3,6, 12 and 24 months.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.

Other

MeasureTime frameDescription
Marginal Coloration Evaluation CriteriaFollowing the sealant application, checks will be made at3, 6, 12 and 24 monthsMarginal 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.
Anatomical Form Evaluation CriteriaFollowing the sealant application, checks will be made at 3,6, 12 and 24 monthsAnatomical Form Evaluation Criteria 0 Consistent with and continuous with occlusal form and structure. 1 Change in anatomical form but all pits and fissures covered. 2a 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

Countries

Turkey (Türkiye)

Contacts

Primary Contactalem coşgun
alemcosgun@hotmail.com+905524133222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026