A Randomized Controlled Clinical Trial Comparing Fissure Sealant Retention Rate, Chair Time, and Patients' Preference Using Dryshield and Cotton Roll Isolation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in Fissure Sealant Retention at 6 months
研究概览
简要总结
The trial aimed to evaluate the sealant retention, patient's preference and chair time needed during pit and fissure sealant placement under two isolation techniques [Dryshield system (DS) and cotton roll isolation (CRI)] in a university setting.
详细描述
In children, 80-90% of dental caries is found in the pits and fissures of the posterior permanent teeth. Pit and fissure sealants (PFS) can be used effectively to prevent dental caries. When applied correctly, dental PFS accomplish three main objectives: preventing dental caries development, hindering dental caries development in its initial phases, and inhibiting the spread of bacteria that cause dental caries. To be effective, PFS need to be applied under sufficient moisture control around the specific teeth undergoing treatment. Therefore, proper isolation of the teeth is one of the most important steps when placing sealants to ensure their retention.
Cotton roll isolation (CRI) has been widely used for sealant placement, and is the most common method among pediatric dentists. However, the placement of cotton rolls on the lateral part of the tongue or inadequate isolation during CRI has both been reported to produce gagging, tasting the contents and requiring frequent replacement of the wet cotton rolls.
A previous study demonstrated that new moisture control systems such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while decreasing procedure time. DryShield (DS) has recently been introduced as an all-in-one isolation system. It is similar to the Isolite as it combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block, but differs in that it is autoclavable and does not provide illumination. Its design allows it to suction and isolate half the oral cavity at a time. Therefore, it should presumably facilitate sealants placement under a more controlled environment, while reducing chair time for the dentist.
Few trials have compared the PFS chair time and patient acceptance of DS to the CRI. The goals of this study were to evaluate patients' preferences, time efficiency, and retention of PFS using DS compared to CRI in a single randomized clinical study.
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
- Single (Outcomes Assessor)
盲法说明
The participants, care providers and the principle supervisor were not blinded since they know which isolation technique was used during the placement of sealant. But the outcome assessor was blinded and he assessed the sealants placement after 6, 12, and 18 months.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients with no compromising medical or physical condition
- •age ranging from six to 12 years old;
- •patients with at least one caries-free permanent molar in any quadrant, with normal anatomy, who qualified for pit and fissure sealant application with an International Caries Detection and Assessment System (ICDAS) score of 0-
- •no prior sealants or restorations on the teeth under study;
- •no cavitated carious lesions;
- •cooperative patients (classified as 3 or 4 according to the Frankl Behavioral Rating Scale)
- •legal guardian consents and approved assents to the child's participation in the study.
排除标准
- •a history of chronic disease (e.g., epilepsy, ectodermal dysplasia, cardiac anomalies);
- •inability to return for follow-ups.
- •patients with molars that have partially erupted
- •a permanent molar with enamel flaws or abnormal anatomy
- •children who are uncooperative, with a Frankl Behaviour Rating Scale of 1 or 2;
- •children who have a severe gagging reflex;
- •special needs children.
- •Those who do not provide appropriate assents or consents
结局指标
主要结局
Change in Fissure Sealant Retention at 6 months
时间窗: Change in sealant retention at 6 months
Patients were clinically evaluated by a study supervisor as a blinded outcome assessor after 6 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
Change in Fissure Sealant Retention at 12 months
时间窗: Change in sealant retention at 12 months
Patients were clinically evaluated by a study supervisor as a blinded outcome assessor after 12 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
Change in Fissure Sealant Retention at 18 months
时间窗: Change in sealant retention at 18 months
assessor after 18 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
次要结局
- Placement time of sealants using Dryshield vs Cotton roll isolation(0 Day (After the completion of initial sealant placement and removal of the isolation device))
- Patient preference for Dryshield or Cotton roll isolation(0 Day (After the completion of initial sealant placement and removal of the isolation device))
研究者
ABRAR ALANZI
Associate Professor
Kuwait University