Clinical Evaluation of Pit and Fissure Sealants

NCT06987955 | Completed

• 1 other identifier: 23-KAEK-150
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Pit and Fissure Sealants

Keywords

children; BioCoat; Fissurit FX; modified USPHS

Outcome Measures

Primary Outcomes (1)

• 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.

  18 month

Secondary Outcomes (1)

• Comparison of the intraoral survival rates of pit and fissure sealants

  18 month

Study Arms (2)

Mandibular right first molar

Other: Biocoat Pit and fissure sealant

Mandibular right left molar

Other: Fissurit FX Pit and fissure sealant

Interventions

Biocoat Pit and fissure sealant OTHER

Application of Biocoat

Mandibular right first molar

Fissurit FX Pit and fissure sealant OTHER

Application of Fissurit FX

Mandibular right left molar

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canan Bayraktar Nahir: lead
• Tokat Gaziosmanpasa University: collaborator

Study Sites (1)

Tokat Gaziosmanapaş University

Tokat Province, Kaleardı, 60010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

Pit and Fissure Sealants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 23, 2025
• Study Start: August 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

TU (1)