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NCT Number: NCT06987955

Clinical Evaluation of Pit and Fissure Sealants

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.

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Key information

Conditions

Pit and Fissure Sealants Van der Woude syndrome

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokat Gaziosmanapaş University

Tokat Province, Kaleardı, 60010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biocoat Pit and fissure sealant

Other

Application of Biocoat

Fissurit FX Pit and fissure sealant

Other

Application of Fissurit FX

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of the intraoral survival rates of pit and fissure sealants

    Time frame: 18 month

    Comparative evaluation of the cumulative survival curves of pit and fissure sealants over an 18-month follow-up period using Kaplan-Meier analysis.

Sponsors and collaborators

Lead sponsor

Canan Bayraktar Nahir

Other

Collaborators

  • Tokat Gaziosmanpasa University

Registry information

Official study title

Evaluation of Clinical Success of Bioactive and Fluoride Resin Based Pit and Fissure Sealants: A Split Mouth Clinical Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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