Fissure SealantNCT07136051
Evaluation of the Survival of Fissure Sealants Applied With Different Pretreatment Methods on Permanent First Molars: A One-Year Follow-Up
A study testing Ethcing, Deproteinization and Bonding in people with Fissure Sealant and Deproteinization, run by Handan Vural at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aims to evaluate the effect of two different pretreatment protocols-enamel deproteinization and bonding agent application-on the one-year survival of fissure sealants applied to permanent first molars in children. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure Sealant, Deproteinization, Bonding Agent
- What is being tested?
- Ethcing, Deproteinization and Bonding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Aug 2025to May 2027
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 8-15 years.
- Fully erupted or completely impacted teeth that are clinically and radiographically confirmed to be caries-free or present with demineralized fissures scored as ICDAS 1-2.
- Children demonstrating cooperative behavior, with a Frankl Behavior Rating Scale score of 3 or 4.
- Oral Hygiene Index (OHI-S) score ≤ 3
- Written informed consent obtained from the parent or legal guardian.
Who cannot join
- Partially erupted second permanent molars
- Teeth presenting with severe hypoplasia, hypomineralization, extensive restorations, or cavitated carious lesions.
- History of systemic disease or long-term medication use.
- Known allergy to resin-based or glass ionomer materials.
- Presence of parafunctional habits.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University
Battalgazi, Malatya, 44200
About this study
Objective:
This study aims to evaluate the effect of two different pretreatment protocols-enamel deproteinization and bonding agent application-on the one-year survival of fissure sealants applied to permanent first molars in children.
Read more
Background:
Dental caries is a preventable yet highly prevalent multifactorial disease. Deep pits and fissures are particularly susceptible to caries development, especially in newly erupted molars. Although fissure sealants are considered one of the most effective preventive methods, their clinical success is largely dependent on long-term retention. Contamination of etched enamel surfaces with saliva or gingival fluid is a primary cause of sealant failure. To improve sealant adhesion, several pretreatment methods have been suggested, including bonding agents and enamel deproteinization.
Methods:
This randomized, controlled, double-blind clinical trial with a split-mouth design was conducted on healthy children aged 7-14 years. Each child contributed at least three permanent first molars to the study, randomly assigned to one of three groups:
Group A - Acid etching + sealant; Group B - Acid etching + deproteinization + sealant; Group C - Acid etching + bonding agent + sealant. Clinical evaluations were performed at 3, 6, and 12 months using visual and tactile methods. Sealant retention, caries incidence, and marginal discoloration were recorded based on standardized criteria.
Results \& Conclusion:
This study seeks to clarify whether bonding agent or deproteinization pretreatment significantly improves sealant retention and reduces caries incidence compared to the conventional approach. Findings may contribute to defining the most effective clinical protocol for fissure sealant application, ultimately enhancing caries prevention and long-term treatment success in pediatric dental care.
- Conditions
- Fissure Sealant, Deproteinization, Bonding Agent, Molar Teeth, Etching
- Being tested
- Ethcing, Deproteinization, Bonding, Application of resin-based fissure sealant
- Keywords
- fissure sealant, deproteinization, bonding agent, etching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthcingProcedure or surgery
Etching: After polishing all teeth included in the study with a polishing brush, Vococid (Voca, Germany) etching gel will be applied to the surface and left for 15 seconds, then rinsed and dried.
DeproteinizationProcedure or surgery
The teeth randomly assigned to Group B will receive 5.25% NaOCl applied with a sterile cotton pellet for 60 seconds after acid etching, followed by rinsing and drying.
BondingProcedure or surgery
The teeth randomly assigned to Group C will receive Futurabond® M+ (Voco, Germany) applied with a brush following acid etching. After gently drying with air for 5 seconds, the bonding step will be completed by light-curing for 10 seconds.
Application of resin-based fissure sealantProcedure or surgery
After completing the pretreatment steps for all groups, Grandio Seal (Voco GmbH, Germany) will be applied to the pits and fissures on the tooth surface and light-cured for 20 seconds. The procedure will be completed after checking the surface.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Acid etching + sealant | Active comparator | Sealant application is a preventive conservative approach involving the introduction of sealants into the pits and fissures of caries prone teeth; this sealant then bonds to the tooth micromechanically, providing a physical barrier that keeps bacteria away from their source of nutrients. Acid pretreatment of the enamel to enhance retention is considered a standard procedure prior to the application of resin-based fissure sealants. Currently, the most commonly used phosphoric acid concentrations are 35% and 37%. Receives: Procedure: Ethcing; Procedure: Application of resin-based fissure sealant |
| Group B: Acid etching + deproteinization + sealant | Active comparator | The use of phosphoric acid is a well-accepted, conventional method used to create micro-porosities, which are the key in providing sealant retention. However, organic remnants as well as fissure morphology and aprismatic enamel structure can decrease etching ability and thus prevent adequate adhesion.Conventional phosphoric acid can only demineralize the inorganic component of enamel and cannot completely remove the protein content within the enamel. Some proteins are also embedded within the enamel crystals. The inadequate penetration of resin into enamel may also result from the Type 3 etching pattern observed after conventional etching. Studies have shown that after using sodium hypochlorite to remove enamel proteins, Type 1 and Type 2 etching patterns are more frequently observed. The literature indicates that the enamel deproteinization technique with sodium hypochlorite is an effective method for removing organic material from the occlusal enamel surfaces of teeth. Receives: Procedure: Ethcing; Procedure: Deproteinization; Procedure: Application of resin-based fissure sealant |
| Group C: Acid etching + bonding agent + sealant | Active comparator | Various methods for preparing fissures, such as pumice prophylaxis, bonding agents, lasers, air abrasion, and sodium hypochlorite deproteinization, have been recommended to improve sealant retention The use of adhesive systems prior to fissure sealant application had a positive effect on increasing penetration and improving the retention rate. It also appears that the use of bonding-agents that involve a separate acid-etching step (fourth and fifth generations) provides better sealant retention than self-etching adhesives (sixth and seventh generations). Receives: Procedure: Ethcing; Procedure: Bonding; Procedure: Application of resin-based fissure sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.
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: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment
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.
Measured: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.
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. 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
Measured: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start3 Aug 2025
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (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
- Crossover
- Model description
- In this split-mouth design study, at least three fully erupted permanent molars from each participant will be included. The teeth will be randomly allocated into groups, and fissure sealants will be applied with the appropriate pretreatments according to the assigned group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Handan Vural
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor-investigator, Handan Vural, Inonu University
- Investigators
- handan vural, Assistant Professor, Study chair, Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136051
- Sponsor's protocol ID
- 7706
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Publications
Khare M, Suprabha BS, Shenoy R, Rao A. Evaluation of pit-and-fissure sealants placed with four different bonding protocols: a randomized clinical trial. Int J Paediatr Dent. 2017 Nov;27(6):444-453. doi: 10.1111/ipd.12281. Epub 2016 Dec 26.
PubMed 28024165Nair SM, Nene KS, Tirupathi S, Mathur AA, Khan HA, Godbole NM, Patil PP, Deolikar SA. Effect of Enamel Deproteinization Prior to Etching on the Clinical Performance of Resin-based Pit and Fissure Sealants: A Split-mouth Double-blinded Pilot Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Feb;18(2):119-125. doi: 10.5005/jp-journals-10005-3051. Epub 2025 Mar 20.
PubMed 40417445
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Survival of Fissure Sealants Applied With Different Pretreatment Methods on Permanent First Molars: A One-Year Follow-Up
- ClinicalTrials.gov ID
- NCT07136051
- Acronym / sponsor ID
- 7706
- Conditions
- Fissure Sealant, Deproteinization, Bonding Agent, Molar Teeth, Etching
- Keywords
- fissure sealant, deproteinization, bonding agent, etching
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Handan VuralUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 3 Aug 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Aug 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.
Objective:
This study aims to evaluate the effect of two different pretreatment protocols-enamel deproteinization and bonding agent application-on the one-year survival of fissure sealants applied to permanent first molars in children.
Background:
Dental caries is a preventable yet highly prevalent multifactorial disease. Deep pits and fissures are particularly susceptible to caries development, especially in newly erupted molars. Although fissure sealants are considered one of the most effective preventive methods, their clinical success is largely dependent on long-term retention. Contamination of etched enamel surfaces with saliva or gingival fluid is a primary cause of sealant failure. To improve sealant adhesion, several pretreatment methods have been suggested, including bonding agents and enamel deproteinization.
Methods:
This randomized, controlled, double-blind clinical trial with a split-mouth design was conducted on healthy children aged 7-14 years. Each child contributed at least three permanent first molars to the study, randomly assigned to one of three groups:
Group A - Acid etching + sealant; Group B - Acid etching + deproteinization + sealant; Group C - Acid etching + bonding agent + sealant. Clinical evaluations were performed at 3, 6, and 12 months using visual and tactile methods. Sealant retention, caries incidence, and marginal discoloration were recorded based on standardized criteria.
Results \& Conclusion:
This study seeks to clarify whether bonding agent or deproteinization pretreatment significantly improves sealant retention and reduces caries incidence compared to the conventional approach. Findings may contribute to defining the most effective clinical protocol for fissure sealant application, ultimately enhancing caries prevention and long-term treatment success in pediatric dental care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- In this split-mouth design study, at least three fully erupted permanent molars from each participant will be included. The teeth will be randomly allocated into groups, and fissure sealants will be applied with the appropriate pretreatments according to the assigned group.
| Arm | Type | Receives |
|---|---|---|
| Group A: Acid etching + sealant | Active comparator | Procedure: Ethcing, Procedure: Application of resin-based fissure sealantSealant application is a preventive conservative approach involving the introduction of sealants into the pits and fissures of caries prone teeth; this sealant then bonds to the tooth micromechanically, providing a physical barrier that keeps bacteria away from their source of nutrients. Acid pretreatment of the enamel to enhance retention is considered a standard procedure prior to the application of resin-based fissure sealants. Currently, the most commonly used phosphoric acid concentrations are 35% and 37%. |
| Group B: Acid etching + deproteinization + sealant | Active comparator | Procedure: Ethcing, Procedure: Deproteinization, Procedure: Application of resin-based fissure sealantThe use of phosphoric acid is a well-accepted, conventional method used to create micro-porosities, which are the key in providing sealant retention. However, organic remnants as well as fissure morphology and aprismatic enamel structure can decrease etching ability and thus prevent adequate adhesion.Conventional phosphoric acid can only demineralize the inorganic component of enamel and cannot completely remove the protein content within the enamel. Some proteins are also embedded within the enamel crystals. The inadequate penetration of resin into enamel may also result from the Type 3 etching pattern observed after conventional etching. Studies have shown that after using sodium hypochlorite to remove enamel proteins, Type 1 and Type 2 etching patterns are more frequently observed. The literature indicates that the enamel deproteinization technique with sodium hypochlorite is an effective method for removing organic material from the occlusal enamel surfaces of teeth. |
| Group C: Acid etching + bonding agent + sealant | Active comparator | Procedure: Ethcing, Procedure: Bonding, Procedure: Application of resin-based fissure sealantVarious methods for preparing fissures, such as pumice prophylaxis, bonding agents, lasers, air abrasion, and sodium hypochlorite deproteinization, have been recommended to improve sealant retention The use of adhesive systems prior to fissure sealant application had a positive effect on increasing penetration and improving the retention rate. It also appears that the use of bonding-agents that involve a separate acid-etching step (fourth and fifth generations) provides better sealant retention than self-etching adhesives (sixth and seventh generations). |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 8-15 years.
- Fully erupted or completely impacted teeth that are clinically and radiographically confirmed to be caries-free or present with demineralized fissures scored as ICDAS 1-2.
- Children demonstrating cooperative behavior, with a Frankl Behavior Rating Scale score of 3 or 4.
- Oral Hygiene Index (OHI-S) score ≤ 3
- Written informed consent obtained from the parent or legal guardian.
Key exclusion criteria (5 listed)
- Partially erupted second permanent molars
- Teeth presenting with severe hypoplasia, hypomineralization, extensive restorations, or cavitated carious lesions.
- History of systemic disease or long-term medication use.
- Known allergy to resin-based or glass ionomer materials.
- Presence of parafunctional habits.
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 |
|---|---|---|
| EthcingEtching: After polishing all teeth included in the study with a polishing brush, Vococid (Voca, Germany) etching gel will be applied to the surface and left for 15 seconds, then rinsed and dried. | Procedure or surgery | Group A: Acid etching + sealant, Group B: Acid etching + deproteinization + sealant, Group C: Acid etching + bonding agent + sealant |
| DeproteinizationThe teeth randomly assigned to Group B will receive 5.25% NaOCl applied with a sterile cotton pellet for 60 seconds after acid etching, followed by rinsing and drying. | Procedure or surgery | Group B: Acid etching + deproteinization + sealant |
| BondingThe teeth randomly assigned to Group C will receive Futurabond® M+ (Voco, Germany) applied with a brush following acid etching. After gently drying with air for 5 seconds, the bonding step will be completed by light-curing for 10 seconds. | Procedure or surgery | Group C: Acid etching + bonding agent + sealant |
| Application of resin-based fissure sealantAfter completing the pretreatment steps for all groups, Grandio Seal (Voco GmbH, Germany) will be applied to the pits and fissures on the tooth surface and light-cured for 20 seconds. The procedure will be completed after checking the surface. | Procedure or surgery | Group A: Acid etching + sealant, Group B: Acid etching + deproteinization + sealant, Group C: Acid etching + bonding agent + sealant |
Primary outcome
Modified Simonsen Criteria
Time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.
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
Edge Integrity Evaluation Criteria
Time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment
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
Marginal Coloration Evaluation Criteria
Time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.
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 Criteria
Time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.
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
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 28 Aug 2025.
- Background: PubMed 28024165Khare M, Suprabha BS, Shenoy R, Rao A. Evaluation of pit-and-fissure sealants placed with four different bonding protocols: a randomized clinical trial. Int J Paediatr Dent. 2017 Nov;27(6):444-453. doi: 10.1111/ipd.12281. Epub 2016 Dec 26.
- Background: PubMed 40417445Nair SM, Nene KS, Tirupathi S, Mathur AA, Khan HA, Godbole NM, Patil PP, Deolikar SA. Effect of Enamel Deproteinization Prior to Etching on the Clinical Performance of Resin-based Pit and Fissure Sealants: A Split-mouth Double-blinded Pilot Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Feb;18(2):119-125. doi: 10.5005/jp-journals-10005-3051. Epub 2025 Mar 20.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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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. This study is not recruiting at the moment.
handan vural, Assistant Professor study chair
Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethcing, Deproteinization and Bonding in people with Fissure Sealant and Deproteinization, run by Handan Vural 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 5 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Simonsen Criteria (time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.). The study lists 4 primary outcomes in all. 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 NCT07136051, 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 28 Aug 2025.