Fissure SealantNCT07110701
Clinical Evaluation Fissure Sealants Applied With Different Isolation Techniques
A study testing Retention of the fissure sealants evaluated in people with Fissure Sealant and Rubberdam, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study was to evaluate the effects of different isolation methods and material filler ratios on the retention rates of two different fluoride-containing fissure sealants over an 18-month period. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure Sealant, Rubberdam, Isolation
- What is being tested?
- Retention of the fissure sealants evaluated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The study comprised 100 healthy children aged between 6 and 12 years
- ASA class I (American Society of Anesthesiologists),
- exhibit cooperative behavior with a score of 3 or 4 on the Frankl Behavior Rating Scale.
- All participants has to be fully erupted lower first permanent molars on both sides (200 teeth), which required the application of pit and fissure sealants.
- The inclusion criteria is based on the International Caries Detection and Assessment System II (ICDAS II) criteria, including deep and retained pits and fissures, no restorations, and no evidence of caries lesions
Who cannot join
- Participants with special needs or systemic disease (ASA classification II or higher),
- requiring emergency dental care,
- suffering from a severe gag reflex or an allergy to latex,
- exhibiting uncooperative behavior (Frankl Score 1 or 2),
- exhibiting molars with anomalies of the enamel/dentin, or
- unable to attend follow-up appointments were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University
Izmir, Çiğli, 35640
About this study
Official title: A Comparative Clinical Evaluation of Two Resin-Based Fissure Sealants Applied With Different Isolation Techniques: An 18-Month Follow-Up Study
The aim of this clinical study was to evaluate the effects of different isolation methods and material filler ratios on the retention rates of two different fluoride-containing fissure sealants over an 18-month period.
Methods:
A total of 100 children (200 teeth) participated in this randomized, single-blind, split-mouth clinical trial. The mandibular permanent first molars of each participant were divided into two groups: one receiving a highly filled fluoride-releasing fissure sealant (Fissurit FX, Voco, Germany), and the other an unfilled fluoride-releasing sealant (Teethmate F-1, Kuraray, Germany). Each material group was also divided into two subgroups based on the isolation method used: rubber dam or cotton roll isolation. Sealant retention rates were evaluated at 6-, 12-, and 18-month follow-up visits. Data were statistically analyzed using a 0.05 significance level.
Read the detailed description
The aim of this randomized, controlled clinical trial was to assess (i) the retention rates of two different resin-based fissure sealant materials-one containing a high filler content and the other unfilled, both fluoride-releasing-and (ii) the effect of the isolation method (rubber dam versus cotton roll isolation) on sealant retention. Additionally, the study evaluated the effectiveness of these materials and isolation techniques in the prevention of dental caries. The null hypotheses tested were: (i) there is no significant difference in the retention rates between the two types of resin-based fissure sealants, and (ii) the type of isolation method employed does not significantly influence sealant retention.
Study Design:
This randomized, controlled, single-blind clinical trial was approved by the Medical Ethics Committee of Izmir Katip Celebi University (Approval No: 2025/059). Prior to the commencement of treatment, written informed consent was obtained from the parents or legal guardians of all participants. The study was conducted in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure the transparency and integrity of the methodology and results.
The study included 100 healthy children between the ages of 6 and 12 years (mean age: 7.9 years), all classified as ASA Class I (American Society of Anesthesiologists) and exhibiting cooperative behavior, as determined by a Frankl Behavior Rating Scale score of 3 or 4. All participants had fully erupted mandibular first permanent molars on both sides (totaling 200 teeth) requiring the application of pit-and-fissure sealants.
The clinical procedures were conducted by two trained investigators: one responsible for the baseline examination and treatment, and the other-blinded to the materials and methods used-responsible for follow-up assessments. Examiner calibration was performed at 20 randomly selected sites, and agreement was considered acceptable upon achieving substantial inter-examiner reliability (Cohen's Kappa ≥ 0.7).
Prior to enrollment, 178 children were screened by the primary operator, who assessed caries presence using visual inspection based on ICDAS criteria. Participants' medical and dental histories were recorded, and a clinical examination was performed using a blunt explorer and mouth mirror. Radiographic evaluation, including bilateral bitewing radiographs, was conducted to ensure the absence of dental caries in the target molars.
Caries risk assessment was performed using the Cariogram software (CarEng, version 3.0, Malmö University, Sweden). Factors included in the risk profile were: caries experience (DMFT/DMFS indices, new caries within the past year, existing restorations and missing teeth), presence of systemic conditions, dietary habits (particularly sugar intake), frequency of meals and snacks, Silness-Löe Plaque Index scores, Streptococcus mutans levels in saliva (assessed via strip test), fluoride exposure, salivary flow rate (stimulated saliva test), and salivary buffer capacity (measured using Saliva-Check Buffer or equivalent strip tests). Only patients identified as having a moderate risk of caries were included.
Eligible participants were enrolled following informed consent and child assent. Evaluation of the pit-and-fissure sealants was conducted at 6-, 12-, and 18-month recall appointments to monitor the presence of carious lesions and sealant retention. Assessments were performed by a calibrated pediatric dentist who remained blinded to the materials used. Prior to evaluation, teeth were cleaned with a toothbrush, air-dried, and examined under appropriate illumination. Caries lesions were recorded using the ICDAS II criteria, and sealant retention was classified as follows:
- = Complete retention
- = Partial loss
- = Complete loss
Sealants exhibiting complete loss at any recall visit were re-applied; however, such teeth were withdrawn from further statistical analysis and recorded as failures throughout the remainder of the follow-up period.
- Conditions
- Fissure Sealant, Rubberdam, Isolation
- Being tested
- Retention of the fissure sealants evaluated
- Keywords
- Resin-Based Fissure Sealants, isolation techniques, rubberdam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retention of the fissure sealants evaluatedOther
Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.
| Study group | Role | What they receive |
|---|---|---|
| a highly filled fluoride-containing fissure sealant with rubber dam isolation | Active comparator | Plaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in conjunction with a non-fluoridated prophylactic paste. In accordance with the randomization protocol, and subsequent to the allocation of materials and isolation techniques for each quadrant, individual teeth were isolated using a rubber dam to ensure optimal protection against salivary contamination. All clinical procedures were performed under standardized illumination and strictly adhered to the manufacturers' guidelines. The polymerization of the highly filled, fluoride-releasing fissure sealant was executed using a calibrated LED light-curing unit. Following application, each sealant was rigorously assessed for the absence of air entrapment, quality of marginal adaptation, retention, and the adequacy of polymerization. Receives: Other: Retention of the fissure sealants evaluated |
| a highly filled fluoride-containing fissure sealant with cotton roll isolation, | Active comparator | Plaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in combination with a non-fluoridated prophylactic paste. In line with the randomization protocol and subsequent allocation of the materials and isolation methods for each side of the patient, individual teeth were isolated using cotton rolls in conjunction with high-volume suction to minimize the risk of salivary contamination. All procedures were performed under standardized illumination and strictly followed the manufacturers' instructions. Polymerization of the highly filled, fluoride-releasing fissure sealant was carried out using a calibrated LED light-curing unit. Following application, each sealant was carefully evaluated for the presence of air voids, the quality of marginal adaptation, retention, and the completeness of polymerization. Receives: Other: Retention of the fissure sealants evaluated |
| an unfilled fluoride-containing fissure sealant with rubber dam isolation, | Active comparator | Plaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in conjunction with a non-fluoridated prophylactic paste. In accordance with the randomization protocol and following the allocation of materials and isolation methods for each side of the patient, individual teeth were isolated using a rubber dam to ensure effective prevention of salivary contamination. All clinical procedures were performed under standardized illumination and in strict compliance with the manufacturers' instructions. Polymerization of the unfilled, fluoride-releasing fissure sealant was performed using a calibrated LED light-curing unit. Following the application, each sealant was thoroughly evaluated for the presence of air voids, marginal adaptation, retention, and completeness of polymerization. Receives: Other: Retention of the fissure sealants evaluated |
| an unfilled fluoride-containing fissure sealant with cotton roll isolation. | Active comparator | Plaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in combination with a non-fluoridated prophylactic paste. In line with the randomization protocol and subsequent determination of the materials and isolation techniques for each side of the patient, individual teeth were isolated using cotton rolls in conjunction with high-volume suction to minimize salivary contamination. All procedures were carried out under standardized illumination and in strict accordance with the manufacturers' recommendations. Polymerization of the unfilled, fluoride-releasing fissure sealant was performed using a calibrated LED light-curing unit. Following each application, the sealant was thoroughly evaluated for the presence of air voids, quality of marginal adaptation, retention, and completeness of polymerization. Receives: Other: Retention of the fissure sealants evaluated |
What is being measured
The primary outcome is the main question the study is designed to answer.
The retention rates of two different resin-based fissure sealant materials (a pit and fissure sealant containing high-filler fluoride and a pit and fissure sealant containing non-filler fluoride)
Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.
Measured: The evaluation of pit-and-fissure sealants was conducted to record the presence of caries lesions and sealant retention at 6-, 12-, and 18-month follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 Jun 2023
- Primary completion15 Sep 2023
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Model description
- The randomized, controlled, single-blind clinical study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru KUCUKYİLMAZ, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110701
- Sponsor's protocol ID
- 2025/059
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hicks MJ, Flaitz CM. Epidemiology of dental caries in the pediatric and adolescent population: a review of past and current trends. J Clin Pediatr Dent. 1993 Fall;18(1):43-9.
PubMed 8110613Brown LJ, Kaste LM, Selwitz RH, Furman LJ. Dental caries and sealant usage in U.S. children, 1988-1991: selected findings from the Third National Health and Nutrition Examination Survey. J Am Dent Assoc. 1996 Mar;127(3):335-43. doi: 10.14219/jada.archive.1996.0203.
PubMed 8819780Bahrololoomi Z, Soleymani A, Heydari Z. In vitro comparison of microleakage of two materials used as pit and fissure sealants. J Dent Res Dent Clin Dent Prospects. 2011 Summer;5(3):83-6. doi: 10.5681/joddd.2011.019. Epub 2011 Sep 5.
PubMed 22991611Deery C. Caries detection and diagnosis, sealants and management of the possibly carious fissure. Br Dent J. 2013 Jun;214(11):551-7. doi: 10.1038/sj.bdj.2013.525.
PubMed 23744208Ripa LW. Sealants revisted: an update of the effectiveness of pit-and-fissure sealants. Caries Res. 1993;27 Suppl 1:77-82. doi: 10.1159/000261608.
PubMed 8500131Ahovuo-Saloranta A, Hiiri A, Nordblad A, Worthington H, Makela M. Pit and fissure sealants for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev. 2004;(3):CD001830. doi: 10.1002/14651858.CD001830.pub2.
PubMed 15266455Feigal RJ. The use of pit and fissure sealants. Pediatr Dent. 2002 Sep-Oct;24(5):415-22.
PubMed 12412955Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.
PubMed 18310730Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.
PubMed 25303507Kucukyilmaz E, Savas S, Ozdemir T, Celik MN. Comparison of retention of resin-based filled and unfilled pit and fissure sealants using different isolation techniques. Sci Rep. 2026 Feb 14;16(1):9055. doi: 10.1038/s41598-026-40093-6.
PubMed 41691032
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Evaluation of Two Resin-Based Fissure Sealants Applied With Different Isolation Techniques: An 18-Month Follow-Up Study
- ClinicalTrials.gov ID
- NCT07110701
- Acronym / sponsor ID
- 2025/059
- Conditions
- Fissure Sealant, Rubberdam, Isolation
- Keywords
- Resin-Based Fissure Sealants, isolation techniques, rubberdam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 7 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.
The aim of this clinical study was to evaluate the effects of different isolation methods and material filler ratios on the retention rates of two different fluoride-containing fissure sealants over an 18-month period.
Methods:
A total of 100 children (200 teeth) participated in this randomized, single-blind, split-mouth clinical trial. The mandibular permanent first molars of each participant were divided into two groups: one receiving a highly filled fluoride-releasing fissure sealant (Fissurit FX, Voco, Germany), and the other an unfilled fluoride-releasing sealant (Teethmate F-1, Kuraray, Germany). Each material group was also divided into two subgroups based on the isolation method used: rubber dam or cotton roll isolation. Sealant retention rates were evaluated at 6-, 12-, and 18-month follow-up visits. Data were statistically analyzed using a 0.05 significance level.
Detailed description
The aim of this randomized, controlled clinical trial was to assess (i) the retention rates of two different resin-based fissure sealant materials-one containing a high filler content and the other unfilled, both fluoride-releasing-and (ii) the effect of the isolation method (rubber dam versus cotton roll isolation) on sealant retention. Additionally, the study evaluated the effectiveness of these materials and isolation techniques in the prevention of dental caries. The null hypotheses tested were: (i) there is no significant difference in the retention rates between the two types of resin-based fissure sealants, and (ii) the type of isolation method employed does not significantly influence sealant retention.
Study Design:
This randomized, controlled, single-blind clinical trial was approved by the Medical Ethics Committee of Izmir Katip Celebi University (Approval No: 2025/059). Prior to the commencement of treatment, written informed consent was obtained from the parents or legal guardians of all participants. The study was conducted in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure the transparency and integrity of the methodology and results.
The study included 100 healthy children between the ages of 6 and 12 years (mean age: 7.9 years), all classified as ASA Class I (American Society of Anesthesiologists) and exhibiting cooperative behavior, as determined by a Frankl Behavior Rating Scale score of 3 or 4. All participants had fully erupted mandibular first permanent molars on both sides (totaling 200 teeth) requiring the application of pit-and-fissure sealants.
The clinical procedures were conducted by two trained investigators: one responsible for the baseline examination and treatment, and the other-blinded to the materials and methods used-responsible for follow-up assessments. Examiner calibration was performed at 20 randomly selected sites, and agreement was considered acceptable upon achieving substantial inter-examiner reliability (Cohen's Kappa ≥ 0.7).
Prior to enrollment, 178 children were screened by the primary operator, who assessed caries presence using visual inspection based on ICDAS criteria. Participants' medical and dental histories were recorded, and a clinical examination was performed using a blunt explorer and mouth mirror. Radiographic evaluation, including bilateral bitewing radiographs, was conducted to ensure the absence of dental caries in the target molars.
Caries risk assessment was performed using the Cariogram software (CarEng, version 3.0, Malmö University, Sweden). Factors included in the risk profile were: caries experience (DMFT/DMFS indices, new caries within the past year, existing restorations and missing teeth), presence of systemic conditions, dietary habits (particularly sugar intake), frequency of meals and snacks, Silness-Löe Plaque Index scores, Streptococcus mutans levels in saliva (assessed via strip test), fluoride exposure, salivary flow rate (stimulated saliva test), and salivary buffer capacity (measured using Saliva-Check Buffer or equivalent strip tests). Only patients identified as having a moderate risk of caries were included.
Eligible participants were enrolled following informed consent and child assent. Evaluation of the pit-and-fissure sealants was conducted at 6-, 12-, and 18-month recall appointments to monitor the presence of carious lesions and sealant retention. Assessments were performed by a calibrated pediatric dentist who remained blinded to the materials used. Prior to evaluation, teeth were cleaned with a toothbrush, air-dried, and examined under appropriate illumination. Caries lesions were recorded using the ICDAS II criteria, and sealant retention was classified as follows:
- = Complete retention
- = Partial loss
- = Complete loss
Sealants exhibiting complete loss at any recall visit were re-applied; however, such teeth were withdrawn from further statistical analysis and recorded as failures throughout the remainder of the follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The randomized, controlled, single-blind clinical study
| Arm | Type | Receives |
|---|---|---|
| a highly filled fluoride-containing fissure sealant with rubber dam isolation | Active comparator | Other: Retention of the fissure sealants evaluatedPlaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in conjunction with a non-fluoridated prophylactic paste. In accordance with the randomization protocol, and subsequent to the allocation of materials and isolation techniques for each quadrant, individual teeth were isolated using a rubber dam to ensure optimal protection against salivary contamination. All clinical procedures were performed under standardized illumination and strictly adhered to the manufacturers' guidelines. The polymerization of the highly filled, fluoride-releasing fissure sealant was executed using a calibrated LED light-curing unit. Following application, each sealant was rigorously assessed for the absence of air entrapment, quality of marginal adaptation, retention, and the adequacy of polymerization. |
| a highly filled fluoride-containing fissure sealant with cotton roll isolation, | Active comparator | Other: Retention of the fissure sealants evaluatedPlaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in combination with a non-fluoridated prophylactic paste. In line with the randomization protocol and subsequent allocation of the materials and isolation methods for each side of the patient, individual teeth were isolated using cotton rolls in conjunction with high-volume suction to minimize the risk of salivary contamination. All procedures were performed under standardized illumination and strictly followed the manufacturers' instructions. Polymerization of the highly filled, fluoride-releasing fissure sealant was carried out using a calibrated LED light-curing unit. Following application, each sealant was carefully evaluated for the presence of air voids, the quality of marginal adaptation, retention, and the completeness of polymerization. |
| an unfilled fluoride-containing fissure sealant with rubber dam isolation, | Active comparator | Other: Retention of the fissure sealants evaluatedPlaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in conjunction with a non-fluoridated prophylactic paste. In accordance with the randomization protocol and following the allocation of materials and isolation methods for each side of the patient, individual teeth were isolated using a rubber dam to ensure effective prevention of salivary contamination. All clinical procedures were performed under standardized illumination and in strict compliance with the manufacturers' instructions. Polymerization of the unfilled, fluoride-releasing fissure sealant was performed using a calibrated LED light-curing unit. Following the application, each sealant was thoroughly evaluated for the presence of air voids, marginal adaptation, retention, and completeness of polymerization. |
| an unfilled fluoride-containing fissure sealant with cotton roll isolation. | Active comparator | Other: Retention of the fissure sealants evaluatedPlaque and debris were meticulously removed from the occlusal surfaces using a rotary brush in combination with a non-fluoridated prophylactic paste. In line with the randomization protocol and subsequent determination of the materials and isolation techniques for each side of the patient, individual teeth were isolated using cotton rolls in conjunction with high-volume suction to minimize salivary contamination. All procedures were carried out under standardized illumination and in strict accordance with the manufacturers' recommendations. Polymerization of the unfilled, fluoride-releasing fissure sealant was performed using a calibrated LED light-curing unit. Following each application, the sealant was thoroughly evaluated for the presence of air voids, quality of marginal adaptation, retention, and completeness of polymerization. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The study comprised 100 healthy children aged between 6 and 12 years
- ASA class I (American Society of Anesthesiologists),
- exhibit cooperative behavior with a score of 3 or 4 on the Frankl Behavior Rating Scale.
- All participants has to be fully erupted lower first permanent molars on both sides (200 teeth), which required the application of pit and fissure sealants.
- The inclusion criteria is based on the International Caries Detection and Assessment System II (ICDAS II) criteria, including deep and retained pits and fissures, no restorations, and no evidence of caries lesions
Key exclusion criteria (6 listed)
- Participants with special needs or systemic disease (ASA classification II or higher),
- requiring emergency dental care,
- suffering from a severe gag reflex or an allergy to latex,
- exhibiting uncooperative behavior (Frankl Score 1 or 2),
- exhibiting molars with anomalies of the enamel/dentin, or
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 |
|---|---|---|
| Retention of the fissure sealants evaluatedFollowing classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss. | Other | a highly filled fluoride-containing fissure sealant with cotton roll isolation,, a highly filled fluoride-containing fissure sealant with rubber dam isolation, an unfilled fluoride-containing fissure sealant with cotton roll isolation., an unfilled fluoride-containing fissure sealant with rubber dam isolation, |
Primary outcome
The retention rates of two different resin-based fissure sealant materials (a pit and fissure sealant containing high-filler fluoride and a pit and fissure sealant containing non-filler fluoride)
Time frame: The evaluation of pit-and-fissure sealants was conducted to record the presence of caries lesions and sealant retention at 6-, 12-, and 18-month follow-up visits.
Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 8110613Hicks MJ, Flaitz CM. Epidemiology of dental caries in the pediatric and adolescent population: a review of past and current trends. J Clin Pediatr Dent. 1993 Fall;18(1):43-9.
- Background: PubMed 8819780Brown LJ, Kaste LM, Selwitz RH, Furman LJ. Dental caries and sealant usage in U.S. children, 1988-1991: selected findings from the Third National Health and Nutrition Examination Survey. J Am Dent Assoc. 1996 Mar;127(3):335-43. doi: 10.14219/jada.archive.1996.0203.
- Background: PubMed 22991611Bahrololoomi Z, Soleymani A, Heydari Z. In vitro comparison of microleakage of two materials used as pit and fissure sealants. J Dent Res Dent Clin Dent Prospects. 2011 Summer;5(3):83-6. doi: 10.5681/joddd.2011.019. Epub 2011 Sep 5.
- Background: PubMed 23744208Deery C. Caries detection and diagnosis, sealants and management of the possibly carious fissure. Br Dent J. 2013 Jun;214(11):551-7. doi: 10.1038/sj.bdj.2013.525.
- Background: PubMed 8500131Ripa LW. Sealants revisted: an update of the effectiveness of pit-and-fissure sealants. Caries Res. 1993;27 Suppl 1:77-82. doi: 10.1159/000261608.
- Background: PubMed 15266455Ahovuo-Saloranta A, Hiiri A, Nordblad A, Worthington H, Makela M. Pit and fissure sealants for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev. 2004;(3):CD001830. doi: 10.1002/14651858.CD001830.pub2.
- Background: PubMed 12412955Feigal RJ. The use of pit and fissure sealants. Pediatr Dent. 2002 Sep-Oct;24(5):415-22.
- Background: PubMed 18310730Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.
- Background: PubMed 25303507Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.
- Derived from this study: PubMed 41691032Kucukyilmaz E, Savas S, Ozdemir T, Celik MN. Comparison of retention of resin-based filled and unfilled pit and fissure sealants using different isolation techniques. Sci Rep. 2026 Feb 14;16(1):9055. doi: 10.1038/s41598-026-40093-6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retention of the fissure sealants evaluated in people with Fissure Sealant and Rubberdam, run by Izmir Katip Celebi 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 6 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: finished, as of the sponsor's last update on 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The retention rates of two different resin-based fissure sealant materials (a pit and fissure sealant containing high-filler fluoride and a pit and fissure sealant containing non-filler fluoride) (time frame: The evaluation of pit-and-fissure sealants was conducted to record the presence of caries lesions and sealant retention at 6-, 12-, and 18-month follow-up visits.). 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 NCT07110701, which also lists 10 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 7 Aug 2025.