Pit and Fissure SealantsNCT06987955
Clinical Evaluation of Pit and Fissure Sealants
An observational study of Pit and Fissure Sealants, run by Canan Bayraktar Nahir at 1 site in Turkey (Türkiye).
Trial summary
Pit and fissure sealants are considered an effective preventive approach in protecting teeth from caries, particularly by transforming deep, plaque-retentive occlusal surfaces into smooth, easily cleanable areas. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit and Fissure Sealants
- What is being tested?
- Biocoat Pit and fissure sealant and Fissurit FX Pit and fissure sealant
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Apr 2025
- Phase
- Observational
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 7-9 years old who apply to Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pedodontics.
Who may be able to join
- Parental consent obtained Cooperative behavior rating of 3 or 4 according to the Frankl Behavior Rating Scale Requirement for non-invasive pit and fissure sealant application Age between 7 and 9 years
Who cannot join
- Presence of mental or physical disability History of allergy to any medication or dental restorative material Presence of parafunctional habits Cooperative behavior rating of 1 or 2 according to the Frankl Behavior Rating Scale
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanapaş University
Tokat Province, Kaleardı, 60010
About this study
Official title: Evaluation of Clinical Success of Bioactive and Fluoride Resin Based Pit and Fissure Sealants: A Split Mouth Clinical Study
Pit and fissure sealants are considered an effective preventive approach in protecting teeth from caries, particularly by transforming deep, plaque-retentive occlusal surfaces into smooth, easily cleanable areas. These materials act as a physical barrier on the tooth surface, limiting the access of microorganisms to nutrients and thereby inhibiting bacterial activity. In this thesis study, the long-term clinical performance of a newly introduced bioactive resin-based pit and fissure sealant, BioCoat™ (Premier, USA), was compared with that of a fluoride-releasing resin-based sealant, Fissurit FX (Voco, Germany). The null hypothesis of the study was that there would be no statistically significant difference in the clinical success rates between the two sealant materials.
Read the detailed description
This study was designed to evaluate the clinical effectiveness of BioCoat™ (Premier, USA), a newly introduced bioactive resin-based pit and fissure sealant, and Fissurit FX (Voco, Germany), a fluoride-releasing resin-based sealant, in children aged 7 to 9 years who presented to the Department of Pedodontics at the Faculty of Dentistry, Tokat Gaziosmanpaşa University.
Sealants were applied to the mandibular first permanent molars (teeth 36 and 46) of 63 patients using a split-mouth design. Group 1 received the bioactive material BioCoat™ (Premier, USA), while Group 2 was treated with the fluoride-releasing resin Fissurit FX (Voco, Germany). The sealants were evaluated over an 18-month period based on the modified United States Public Health Service (USPHS) criteria.
The modified USPHS criteria assess parameters including marginal discoloration, marginal adaptation, retention, and the presence of secondary caries in fissure sealant materials. Each parameter is scored as alpha, bravo, or charlie. While alpha and bravo scores indicate clinical success, the presence of a charlie score in any parameter is considered indicative of treatment failure. In clinical follow-ups, cases with one or more charlie (C) scores were classified as unsuccessful, the sealant was replaced, and these cases were excluded from further analysis.
Statistical analysis was performed using IBM SPSS Statistics version 23 (IBM Corp., Armonk, NY, USA). Cochran's Q test was employed to compare intra-group clinical success rates across different time points.
- Conditions
- Pit and Fissure Sealants
- Being tested
- Biocoat Pit and fissure sealant, Fissurit FX Pit and fissure sealant
- Keywords
- children, BioCoat, Fissurit FX, modified USPHS
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biocoat Pit and fissure sealantOther
Application of Biocoat
Fissurit FX Pit and fissure sealantOther
Application of Fissurit FX
| Study group | Role | What they receive |
|---|---|---|
| Mandibular right first molar | Not described Receives: Other: Biocoat Pit and fissure sealant | |
| Mandibular right left molar | Not described Receives: Other: Fissurit FX Pit and fissure sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of 18-month clinical success of pit and fissure sealants
Comparison of the clinical performance of pit and fissure sealants over an 18-month period based on modified USPHS criteria (marginal adaptation, marginal discoloration, retention, and the presence of secondary caries).
Note: The modified USPHS criteria assess parameters including marginal discoloration, marginal adaptation, retention, and the presence of secondary caries in pit anf fissure sealant materials. Each parameter is scored as alpha, bravo, or charlie. While alpha and bravo scores indicate clinical success, the presence of a charlie score in any parameter is considered indicative of treatment failure. In clinical follow-ups, cases with one or more charlie (C) scores were classified as unsuccessful, the sealant was replaced, and these cases were excluded from further analysis.
Measured: 18 month
Secondary outcomes (1)
Comparison of the intraoral survival rates of pit and fissure sealants
Comparative evaluation of the cumulative survival curves of pit and fissure sealants over an 18-month follow-up period using Kaplan-Meier analysis.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Aug 2023
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pit and Fissure SealantsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canan Bayraktar Nahir
- Sponsor type
- University, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Responsible party
- Sponsor-investigator, Canan Bayraktar Nahir, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987955
- Sponsor's protocol ID
- 23-KAEK-150
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: with the link to be prepared later
Publications
Abdelsalam, A. F., Haridy, M. F., Hamza, H. S. E., Farid, M. R., & Shaalan, O. O. (2022). Clinical evaluation of bioactive resin based pits & fissures sealants versus conventional resin based pits & fissures sealants in caries susceptible fissures in permanent molars: A randomized controlled. International Journal of Health Sciences, 6(S7), 2745-2759. Abdelsalam, A. F., Haridy, M. F., Hamza, H. S. E., Farid, M. R., & Shaalan, O. O. (2022). Clinical evaluation of bioactive resin based pits & fissures sealants versus conventional resin based pits & fissures sealants in caries susceptible fissures in permanent molars: A randomized controlled. International Journal of Health Sciences, 6(S7), 2745-2759.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Success of Bioactive and Fluoride Resin Based Pit and Fissure Sealants: A Split Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT06987955
- Acronym / sponsor ID
- 23-KAEK-150
- Conditions
- Pit and Fissure Sealants
- Keywords
- children, BioCoat, Fissurit FX, modified USPHS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Canan Bayraktar NahirUniversity, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 23 May 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.
Pit and fissure sealants are considered an effective preventive approach in protecting teeth from caries, particularly by transforming deep, plaque-retentive occlusal surfaces into smooth, easily cleanable areas. These materials act as a physical barrier on the tooth surface, limiting the access of microorganisms to nutrients and thereby inhibiting bacterial activity. In this thesis study, the long-term clinical performance of a newly introduced bioactive resin-based pit and fissure sealant, BioCoat™ (Premier, USA), was compared with that of a fluoride-releasing resin-based sealant, Fissurit FX (Voco, Germany). The null hypothesis of the study was that there would be no statistically significant difference in the clinical success rates between the two sealant materials.
Detailed description
This study was designed to evaluate the clinical effectiveness of BioCoat™ (Premier, USA), a newly introduced bioactive resin-based pit and fissure sealant, and Fissurit FX (Voco, Germany), a fluoride-releasing resin-based sealant, in children aged 7 to 9 years who presented to the Department of Pedodontics at the Faculty of Dentistry, Tokat Gaziosmanpaşa University.
Sealants were applied to the mandibular first permanent molars (teeth 36 and 46) of 63 patients using a split-mouth design. Group 1 received the bioactive material BioCoat™ (Premier, USA), while Group 2 was treated with the fluoride-releasing resin Fissurit FX (Voco, Germany). The sealants were evaluated over an 18-month period based on the modified United States Public Health Service (USPHS) criteria.
The modified USPHS criteria assess parameters including marginal discoloration, marginal adaptation, retention, and the presence of secondary caries in fissure sealant materials. Each parameter is scored as alpha, bravo, or charlie. While alpha and bravo scores indicate clinical success, the presence of a charlie score in any parameter is considered indicative of treatment failure. In clinical follow-ups, cases with one or more charlie (C) scores were classified as unsuccessful, the sealant was replaced, and these cases were excluded from further analysis.
Statistical analysis was performed using IBM SPSS Statistics version 23 (IBM Corp., Armonk, NY, USA). Cochran's Q test was employed to compare intra-group clinical success rates across different time points.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandibular right first molar | – | Other: Biocoat Pit and fissure sealant |
| Mandibular right left molar | – | Other: Fissurit FX Pit and fissure sealant |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 7-9 years old who apply to Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pedodontics.
Key inclusion criteria (1 listed)
- Parental consent obtained Cooperative behavior rating of 3 or 4 according to the Frankl Behavior Rating Scale Requirement for non-invasive pit and fissure sealant application Age between 7 and 9 years
Key exclusion criteria (1 listed)
- Presence of mental or physical disability History of allergy to any medication or dental restorative material Presence of parafunctional habits Cooperative behavior rating of 1 or 2 according to the Frankl Behavior Rating Scale
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 |
|---|---|---|
| Biocoat Pit and fissure sealantApplication of Biocoat | Other | Mandibular right first molar |
| Fissurit FX Pit and fissure sealantApplication of Fissurit FX | Other | Mandibular right left molar |
Primary outcome
Evaluation of 18-month clinical success of pit and fissure sealants
Time frame: 18 month
Comparison of the clinical performance of pit and fissure sealants over an 18-month period based on modified USPHS criteria (marginal adaptation, marginal discoloration, retention, and the presence of secondary caries). Note: The modified USPHS criteria assess parameters including marginal discoloration, marginal adaptation, retention, and the presence of secondary caries in pit anf fissure sealant materials. Each parameter is scored as alpha, bravo, or charlie. While alpha and bravo scores indicate clinical success, the presence of a charlie score in any parameter is considered indicative of treatment failure. In clinical follow-ups, cases with one or more charlie (C) scores were classified as unsuccessful, the sealant was replaced, and these cases were excluded from further analysis.
1 secondary outcome
Comparison of the intraoral survival rates of pit and fissure sealants
Time frame: 18 month
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 23 May 2025.
- BackgroundAbdelsalam, A. F., Haridy, M. F., Hamza, H. S. E., Farid, M. R., & Shaalan, O. O. (2022). Clinical evaluation of bioactive resin based pits & fissures sealants versus conventional resin based pits & fissures sealants in caries susceptible fissures in permanent molars: A randomized controlled. International Journal of Health Sciences, 6(S7), 2745-2759. Abdelsalam, A. F., Haridy, M. F., Hamza, H. S. E., Farid, M. R., & Shaalan, O. O. (2022). Clinical evaluation of bioactive resin based pits & fissures sealants versus conventional resin based pits & fissures sealants in caries susceptible fissures in permanent molars: A randomized controlled. International Journal of Health Sciences, 6(S7), 2745-2759.
- Clinical evaluation of bioactive resin based pits \& fissures sealants versus conventional resin based pits \& fissures sealants in caries susceptible fissures in permanent molars: A randomized controlled.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. with the link to be prepared later
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Pits and Fissure Sealants
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?
An observational study of Pit and Fissure Sealants, run by Canan Bayraktar Nahir 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 1 inclusion and 1 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 23 May 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?
Evaluation of 18-month clinical success of pit and fissure sealants (time frame: 18 month). 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 NCT06987955, which also lists 1 linked publication.
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 23 May 2025.