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一项关于含氯己定的乳牙牙本质粘结剂与大块充填复合材料的微拉伸粘结强度的前瞻性随机临床试验及体外评估。

A prospective randomized clinical trial and an in vitro evaluation of the microtensile bond strength of a chlorhexidine-containing dentin bonding agent and a bulk fill composite material in primary teeth.

作者信息

Altıntop Hülya, Kuru Hasibe Elif, Ertuğrul Fahinur, Türkün Murat, Küçükyılmaz Ebru

机构信息

Faculty of Dentistry, Department of Pediatric Dentistry, İzmir Katip Çelebi University, İzmir, Turkey.

Faculty of Dentistry, Department of Pediatric Dentistry, Uşak University, Uşak, Turkey.

出版信息

BMC Oral Health. 2025 Apr 13;25(1):566. doi: 10.1186/s12903-025-05960-0.

Abstract

OBJECTIVES

This study aimed to assess the microtensile bond strength of a chlorhexidine-containing dentin bonding agent compared with a standard adhesive, and to investigate its clinical success in Class II cavities in primary teeth, with a 12-month follow-up.

MATERIALS AND METHODS

The study consisted of two parts: a prospective, single-blind, split-mouth randomized controlled clinical trial and an in vitro laboratory evaluation. Ethical approval were obtained for the both parts of the study. Forty pediatric patients (aged 5-9 years) with primary molars requiring Class II restorations were included in the clinical trial, where bulk-fill restorations bonded with a chlorhexidine-containing adhesive and a standard adhesive were evaluated based on FDI criteria at 3-month intervals for 12 months. he in vitro study examined the microtensile bond strength (µTBS) of immediate and thermally aged specimens prepared with bulk-fill composite materials and adhesives with or without chlorhexidine.The data were analyzed using Mann Whitney U test for in-vivo, ANOVA test followed by Tukey's post hoc and Chi-square test for in-vitro study (p = 0.05).

RESULTS

Clinically, both adhesives showed similar success rates (%100) across all FDI evaluation parameters after 12 months (p > 0.05). The chlorhexidine-containing adhesive demonstrated significantly higher microtensile bond strength than the standard adhesive in both immediate and aged samples (p < 0.05).

CONCLUSIONS

The chlorhexidine-containing adhesive showed promising clinical success and improved bond strength compared to the standard adhesive. Longer follow-ups are needed to confirm its long-term durability."Incorporating chlorhexidine simplifies restorative procedures without compromising performance.

CLINICAL RELEVANCE

Chlorhexidine-containing adhesives may improve bond durability and procedural efficiency in pediatric dentistry, offering a practical and effective alternative for restoring primary molars.

TRIAL REGISTRATION

Invivo part of the study was registered in a public trial registry, www.

CLINICALTRIALS

gov (#NCT06257108). Registration Date 2nd. May 2024 (Retrospectively registered).

摘要

目的

本研究旨在评估含氯己定的牙本质粘结剂与标准粘结剂相比的微拉伸粘结强度,并通过12个月的随访,研究其在乳牙II类洞修复中的临床成功率。

材料与方法

本研究包括两部分:一项前瞻性、单盲、半口随机对照临床试验和一项体外实验室评估。研究的两个部分均获得了伦理批准。40名需要对乳磨牙进行II类修复的儿科患者(年龄5-9岁)被纳入临床试验,其中使用含氯己定的粘结剂和标准粘结剂进行的大块充填修复,根据FDI标准,每3个月评估一次,共评估12个月。体外研究检测了使用含或不含氯己定的大块充填复合材料和粘结剂制备的即刻和热老化标本的微拉伸粘结强度(µTBS)。体内数据采用Mann Whitney U检验进行分析,体外研究数据采用方差分析,随后进行Tukey事后检验和卡方检验(p = 0.05)。

结果

临床上,12个月后,两种粘结剂在所有FDI评估参数上的成功率均相似(100%)(p > 0.05)。含氯己定的粘结剂在即刻和老化样本中的微拉伸粘结强度均显著高于标准粘结剂(p < 0.05)。

结论

与标准粘结剂相比,含氯己定的粘结剂显示出良好的临床成功率和更高的粘结强度。需要更长时间的随访来确认其长期耐久性。“加入氯己定简化了修复程序,且不影响性能。

临床意义

含氯己定的粘结剂可能提高儿童牙科的粘结耐久性和操作效率,为修复乳磨牙提供一种实用且有效的替代方法。

试验注册

该研究的体内部分已在公共试验注册库www.CLINICALTRIALS.gov(#NCT06257108)中注册。注册日期为2024年5月2日(追溯注册)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da2b/11995613/d0e716df1933/12903_2025_5960_Figa_HTML.jpg

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