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临床试验/NCT07136051
NCT07136051进行中(未招募)不适用

Evaluation of the Survival of Fissure Sealants Applied With Different Pretreatment Methods on Permanent First Molars: A One-Year Follow-Up

Handan Vural1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Modified Simonsen Criteria

研究概览

简要总结

Objective:

This study aims to evaluate the effect of two different pretreatment protocols-enamel deproteinization and bonding agent application-on the one-year survival of fissure sealants applied to permanent first molars in children.

Background:

Dental caries is a preventable yet highly prevalent multifactorial disease. Deep pits and fissures are particularly susceptible to caries development, especially in newly erupted molars. Although fissure sealants are considered one of the most effective preventive methods, their clinical success is largely dependent on long-term retention. Contamination of etched enamel surfaces with saliva or gingival fluid is a primary cause of sealant failure. To improve sealant adhesion, several pretreatment methods have been suggested, including bonding agents and enamel deproteinization.

Methods:

This randomized, controlled, double-blind clinical trial with a split-mouth design was conducted on healthy children aged 7-14 years. Each child contributed at least three permanent first molars to the study, randomly assigned to one of three groups:

Group A - Acid etching + sealant; Group B - Acid etching + deproteinization + sealant; Group C - Acid etching + bonding agent + sealant. Clinical evaluations were performed at 3, 6, and 12 months using visual and tactile methods. Sealant retention, caries incidence, and marginal discoloration were recorded based on standardized criteria.

Results & Conclusion:

This study seeks to clarify whether bonding agent or deproteinization pretreatment significantly improves sealant retention and reduces caries incidence compared to the conventional approach. Findings may contribute to defining the most effective clinical protocol for fissure sealant application, ultimately enhancing caries prevention and long-term treatment success in pediatric dental care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 15 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy children aged 8-15 years.
  • •Fully erupted or completely impacted teeth that are clinically and radiographically confirmed to be caries-free or present with demineralized fissures scored as ICDAS 1-
  • •Children demonstrating cooperative behavior, with a Frankl Behavior Rating Scale score of 3 or
  • •Oral Hygiene Index (OHI-S) score ≤ 3
  • •Written informed consent obtained from the parent or legal guardian.

排除标准

  • •Partially erupted second permanent molars
  • •Teeth presenting with severe hypoplasia, hypomineralization, extensive restorations, or cavitated carious lesions.
  • •History of systemic disease or long-term medication use.
  • •Known allergy to resin-based or glass ionomer materials.
  • •Presence of parafunctional habits.

研究组 & 干预措施

Group A: Acid etching + sealant

Active Comparator

Sealant application is a preventive conservative approach involving the introduction of sealants into the pits and fissures of caries prone teeth; this sealant then bonds to the tooth micromechanically, providing a physical barrier that keeps bacteria away from their source of nutrients. Acid pretreatment of the enamel to enhance retention is considered a standard procedure prior to the application of resin-based fissure sealants. Currently, the most commonly used phosphoric acid concentrations are 35% and 37%.

干预措施: Ethcing (Procedure)

Group A: Acid etching + sealant

Active Comparator

Sealant application is a preventive conservative approach involving the introduction of sealants into the pits and fissures of caries prone teeth; this sealant then bonds to the tooth micromechanically, providing a physical barrier that keeps bacteria away from their source of nutrients. Acid pretreatment of the enamel to enhance retention is considered a standard procedure prior to the application of resin-based fissure sealants. Currently, the most commonly used phosphoric acid concentrations are 35% and 37%.

干预措施: Application of resin-based fissure sealant (Procedure)

Group B: Acid etching + deproteinization + sealant

Active Comparator

The use of phosphoric acid is a well-accepted, conventional method used to create micro-porosities, which are the key in providing sealant retention. However, organic remnants as well as fissure morphology and aprismatic enamel structure can decrease etching ability and thus prevent adequate adhesion.Conventional phosphoric acid can only demineralize the inorganic component of enamel and cannot completely remove the protein content within the enamel. Some proteins are also embedded within the enamel crystals. The inadequate penetration of resin into enamel may also result from the Type 3 etching pattern observed after conventional etching. Studies have shown that after using sodium hypochlorite to remove enamel proteins, Type 1 and Type 2 etching patterns are more frequently observed. The literature indicates that the enamel deproteinization technique with sodium hypochlorite is an effective method for removing organic material from the occlusal enamel surfaces of teeth.

干预措施: Ethcing (Procedure)

Group B: Acid etching + deproteinization + sealant

Active Comparator

The use of phosphoric acid is a well-accepted, conventional method used to create micro-porosities, which are the key in providing sealant retention. However, organic remnants as well as fissure morphology and aprismatic enamel structure can decrease etching ability and thus prevent adequate adhesion.Conventional phosphoric acid can only demineralize the inorganic component of enamel and cannot completely remove the protein content within the enamel. Some proteins are also embedded within the enamel crystals. The inadequate penetration of resin into enamel may also result from the Type 3 etching pattern observed after conventional etching. Studies have shown that after using sodium hypochlorite to remove enamel proteins, Type 1 and Type 2 etching patterns are more frequently observed. The literature indicates that the enamel deproteinization technique with sodium hypochlorite is an effective method for removing organic material from the occlusal enamel surfaces of teeth.

干预措施: Deproteinization (Procedure)

Group B: Acid etching + deproteinization + sealant

Active Comparator

The use of phosphoric acid is a well-accepted, conventional method used to create micro-porosities, which are the key in providing sealant retention. However, organic remnants as well as fissure morphology and aprismatic enamel structure can decrease etching ability and thus prevent adequate adhesion.Conventional phosphoric acid can only demineralize the inorganic component of enamel and cannot completely remove the protein content within the enamel. Some proteins are also embedded within the enamel crystals. The inadequate penetration of resin into enamel may also result from the Type 3 etching pattern observed after conventional etching. Studies have shown that after using sodium hypochlorite to remove enamel proteins, Type 1 and Type 2 etching patterns are more frequently observed. The literature indicates that the enamel deproteinization technique with sodium hypochlorite is an effective method for removing organic material from the occlusal enamel surfaces of teeth.

干预措施: Application of resin-based fissure sealant (Procedure)

Group C: Acid etching + bonding agent + sealant

Active Comparator

Various methods for preparing fissures, such as pumice prophylaxis, bonding agents, lasers, air abrasion, and sodium hypochlorite deproteinization, have been recommended to improve sealant retention The use of adhesive systems prior to fissure sealant application had a positive effect on increasing penetration and improving the retention rate. It also appears that the use of bonding-agents that involve a separate acid-etching step (fourth and fifth generations) provides better sealant retention than self-etching adhesives (sixth and seventh generations).

干预措施: Ethcing (Procedure)

Group C: Acid etching + bonding agent + sealant

Active Comparator

Various methods for preparing fissures, such as pumice prophylaxis, bonding agents, lasers, air abrasion, and sodium hypochlorite deproteinization, have been recommended to improve sealant retention The use of adhesive systems prior to fissure sealant application had a positive effect on increasing penetration and improving the retention rate. It also appears that the use of bonding-agents that involve a separate acid-etching step (fourth and fifth generations) provides better sealant retention than self-etching adhesives (sixth and seventh generations).

干预措施: Bonding (Procedure)

Group C: Acid etching + bonding agent + sealant

Active Comparator

Various methods for preparing fissures, such as pumice prophylaxis, bonding agents, lasers, air abrasion, and sodium hypochlorite deproteinization, have been recommended to improve sealant retention The use of adhesive systems prior to fissure sealant application had a positive effect on increasing penetration and improving the retention rate. It also appears that the use of bonding-agents that involve a separate acid-etching step (fourth and fifth generations) provides better sealant retention than self-etching adhesives (sixth and seventh generations).

干预措施: Application of resin-based fissure sealant (Procedure)

结局指标

主要结局

Modified Simonsen Criteria

时间窗: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.

Score 0 Fissure sealant is completely in the mouth and there is no new caries. Score 1 Partial loss of fissure sealant, no new caries. Score 2 Partial loss of fissure sealant and new caries. Score 3 Complete loss of fissure sealant, no new caries. Score 4 Complete loss of fissure sealant and new caries

Edge Integrity Evaluation Criteria

时间窗: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment

0: The fissure sealant and tooth surface are intact and cannot be distinguished with a probe. 1: The edges of the fissure sealants can be distinguished with a probe. 2: There is a gap along the edge of the fissure sealant and deep cracks reaching the central fossa

Marginal Coloration Evaluation Criteria

时间窗: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.

0 No color change between fissure sealant and tooth. 1:Color change in only one area. 2:Color change in many areas. 3:Severe color change indicating leakage.

Anatomical Form Evaluation Criteria

时间窗: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.

0 Consistent with and continuous with occlusal form and structure. 1 Change in anatomical form but all pits and fissures covered. 2a Partial loss of one or two pits or fissures but no need to repair or replace fissure sealant. 2b Partial loss of pits and fissures, fissure sealant needs to be replaced or repaired. 3 Loss of all pits and fissures. 7 Partial loss due to occlusion 9 Bleb not connected to margins

次要结局

未报告次要终点

研究者

发起方
Handan Vural
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Handan Vural

Assistant Professor

Inonu University

研究点 (1)

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