Fissure SealantNCT07003958
The Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth
A study testing application of deproteinization agents in people with Fissure Sealant, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure Sealant
- What is being tested?
- application of deproteinization agents
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2024to 5 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tokat Gaziosmanpaşa University, Tokat, 60030
Tokat Province, 60100
alem coşgun, 05524133222, alemcosgun@hotmail.com
About this study
Official title: Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth: Splint Mouth Clinical Study
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
- Being tested
- application of deproteinization agents
- Keywords
- deproteinization agents, sodium hypochlorite, hypochlorous acid, fissure sealent, Primary Teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of deproteinization agentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 ran Receives: Other: application of deproteinization agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Following the sealant application, controls will be made at 3,6, 12 and 24 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.
Measured: Following the sealant application, controls will be made at 3,6, 12 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start5 Aug 2024
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fissure SealantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alem Coşgun, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003958
- Sponsor's protocol ID
- 23-18
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 11145354Simonsen 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.
PubMed 1835987
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth: Splint Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT07003958
- Acronym / sponsor ID
- 23-18
- Conditions
- Fissure Sealant
- Keywords
- deproteinization agents, sodium hypochlorite, hypochlorous acid, fissure sealent, Primary Teeth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Hypochlorite, Wizard | Active comparator | Other: application of deproteinization agentsThere 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. |
| Hypochlorous Acid, Superox | Experimental | Other: application of deproteinization agentsHypochlorous 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 ran |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of deproteinization agentsSince 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. | Other | Hypochlorous Acid, Superox, Sodium Hypochlorite, Wizard |
Primary outcome
Modified Simonsen Criteria
Time frame: Following the sealant application, controls will be made at 3,6, 12 and 24 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.
1 secondary outcome
Edge Integrity Evaluation Criteria
Time frame: Following the sealant application, controls will be made at 3,6, 12 and 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Results publication: PubMed 11145354Feigal 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.
- Results publication: PubMed 1835987Simonsen 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.
- Individual participant dataSharing planned: Yes
Related trials for Fissure Sealant
Active, not recruiting
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
Dental Caries, Fissure Sealant
Enrolling by invitation
Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH).
Molar Incisor Hypomineralization, Fissure Sealant
Not yet recruiting
Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
Pit and Fissure Sealant Retention, Dental Caries
RecruitingPhase 1
COES: Curing Order Effects on Sealants
Dental Sealant, Sealant Retention
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of deproteinization agents in people with Fissure Sealant, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact alem coşgun (+905524133222, alemcosgun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Simonsen Criteria (time frame: Following the sealant application, controls will be made at 3,6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07003958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.