Clinical trial NCT06987955: Clinical Evaluation of Pit and Fissure Sealants
Official title: Evaluation of Clinical Success of Bioactive and Fluoride Resin Based Pit and Fissure Sealants: A Split Mouth Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pit and Fissure Sealants
Keywords: children
BioCoat
Fissurit FX
modified USPHS
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: Tokat Gaziosmanpasa University
First posted: 2025-05-23
Enrollment: 63
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 7-9 years old who apply to Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pedodontics.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluation of 18-month clinical success of pit and fissure sealants
timeFrame: 18 month
Secondary outcomes:
measure: Comparison of the intraoral survival rates of pit and fissure sealants
timeFrame: 18 month
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanapaş University
state: Kaleardı
Study officials:
References:
citation: 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.