Clinical Evaluation of Pit and Fissure Sealants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-04-01

Brief Summary

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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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Detailed Description

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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

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Pit and Fissure Sealants

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Mandibular right first molar

Biocoat Pit and fissure sealant

Intervention Type OTHER

Application of Biocoat

Mandibular right left molar

Fissurit FX Pit and fissure sealant

Intervention Type OTHER

Application of Fissurit FX

Interventions

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Biocoat Pit and fissure sealant

Application of Biocoat

Intervention Type OTHER

Fissurit FX Pit and fissure sealant

Application of Fissurit FX

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes