Clinical Evaluation of Pit and Fissure Sealants

Canan Bayraktar Nahir63 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Eligibility

Sex: ALLMin age: 7 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 18 month

Secondary Outcomes

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.