Clinical And Digital Evaluation Of Wear Resistance Of Bioactive Pits And Fissure Sealant With And Without Etching Versus Conventional Resin Based Pits And Fissure Sealants: A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 23
- 主要终点
- retention of wear resistance of the sealants
研究概览
简要总结
This randomized clinical trial aimed to compare the wear resistance and clinical performance of bioactive versus conventional resin-based pit and fissure sealants over a 12-month period. Conducted on young adults with sound, caries-susceptible molars, the study evaluated three groups: bioactive sealants applied with and without etching, and conventional resin-based sealants with etching. Clinical assessments and 3D digital scans were used to measure sealant retention and wear. The study seeks to determine whether bioactive sealants, especially when applied without etching, provide comparable long-term protection and durability to conventional sealants, potentially simplifying application without compromising effectiveness.
详细描述
This study is a randomized controlled clinical trial designed to evaluate and compare the wear resistance and clinical performance of bioactive pit and fissure sealants-applied with and without acid etching-against conventional resin-based sealants in young adults aged 18-25 with caries-susceptible, sound first permanent molars. Seventy-five teeth were randomly assigned to three groups: Group 1 received a bioactive giomer-based sealant (BeautiSealant) with etching, Group 2 received the same sealant without etching, and Group 3 received a conventional resin-based sealant (Fisseal Promedica) with etching. Sealant retention and wear were evaluated clinically using modified USPHS criteria and digitally using intraoral 3D scanning at baseline, 6 months, and 12 months. The aim was to determine if omitting the etching step in bioactive sealants compromises their effectiveness, offering a simpler yet reliable alternative to conventional methods. The findings are expected to guide clinical decision-making on the most efficient and durable sealant protocols for caries prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged between 18-25 years old with caries susceptible sound fissures and good oral hygiene
- •They should not show any signs of caries by visual tactile examination method and VistaProof fluoroscent camera
- •Teeth should have intact contact with opposing teeth, no previous restorations in other surfaces, no previous sealing procedures and scoring 0.9 or less when tested and VistaProof.
- •Medically free patients.
排除标准
- •Patients with poor oral hygiene, lack of compliance, parafunctional habits, tempro-mandibular joint disorders, periodontal disease, severe medical conditions, allergic history concerning methacrylates, rampant caries, heavy smoking and xerostomia.
- •Teeth with caries pits and fissures, developmental anomalies, periapical pathology or signs of pulpal pathology, hypersensitivity, possible prosthodontic restoration, heavy occlusion and occlusal contacts, history of bruxism, severe periodontal affection and scoring >0.9 when tested with VistaProof
研究组 & 干预措施
Fluoride Releasing bioactive Pit and Fissure Sealant with etchant
Fluoride Releasing bioactive Pit and Fissure Sealant with etchant application.
干预措施: Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp (Other)
Fluoride Releasing bioactive Pit and Fissure Sealant without etchant
Fluoride Releasing bioactive Pit and Fissure Sealant without etchant application.
干预措施: Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti (Other)
conventional resin based pits and fissure sealant
Conventional resin-based sealant with etchant application
干预措施: Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the trad (Other)
结局指标
主要结局
retention of wear resistance of the sealants
时间窗: 3,6,9 and 12 months
modified USPHS criteria
次要结局
- quantitative wear assesment(12 months)
研究者
Rana hossam eldin mahfouz
Master degree student dentist
Cairo University