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NCT Number: NCT06988098

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

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.

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Key information

Conditions

Fissure Sealant

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpaşa University

Tokat Province, 60030, Turkey (Türkiye)

Location status: Recruiting

Location contact

Alem Coşgun

CONTACT

[email protected]

05524133222

Alem Coşgun

PRINCIPAL_INVESTIGATOR

Merve Tatar

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Edge Integrity Evaluation Criteria

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

    Edge Integrity Evaluation Criteria

    0 The fissure sealant and tooth surface are intact and cannot be distinguished with a probe.

    • The edges of the fissure sealants can be distinguished with a probe.
    • There is a gap along the edge of the fissure sealant and deep cracks reaching the central fossa.

Other outcomes

  1. Marginal Coloration Evaluation Criteria

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

    Marginal Coloration Evaluation Criteria

    0 No color change between fissure sealant and tooth.

    • Color change in only one area.
    • Color change in many areas.
    • Severe color change indicating leakage.

  2. Anatomical Form Evaluation Criteria

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

    Anatomical Form Evaluation Criteria

    0 Consistent with and continuous with occlusal form and structure.

    • Change in anatomical form but all pits and fissures covered.
    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alem Coşgun

CONTACT

[email protected]

+905524133222

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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