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评价窝洞制备后剩余牙本质龋的检测方法:一项随机临床试验。

Evaluation of residual carious dentin detection methods after cavity preparation: a randomized clinical trial.

机构信息

Department of Restorative Dentistry, University of Maiduguri of Maiduguri Teaching Hospital, Maiduguri, Borno State, Nigeria.

Department of Restorative Dentistry, Faculty of Dentistry, College of Medical Sciences, University of Maiduguri, Maiduguri, Nigeria.

出版信息

BMC Oral Health. 2024 Nov 29;24(1):1452. doi: 10.1186/s12903-024-05243-0.

Abstract

BACKGROUND

The treatment of caries in dentine poses the challenge of balancing adequate caries removal to prevent residual caries and excessive sound dentine removal. No diagnostic tool is available to define the caries removal limit clinically. This study aimed to determine the efficiency of visual-tactile, caries detector dye (CDD), and laser fluorescence (LF) device methods for diagnosing residual caries after cavity preparation.

METHOD

The study was conducted as a three-arm, double-blinded, parallel-group randomized trial at the Restorative Dentistryclinics of a teaching hospital in northeastern Nigeria. Individualized carious lesions in dentine were randomly allocated to three groups of residual caries diagnosis methods, A (visual-tactile), B (CDD), and C (LF). All carious lesions had caries excavation and cavity preparation using the visual-tactile method. Main outcome measures were based on the assessment of residual caries of prepared cavities in groups B and C with CDD and LF (DIAGNOdent Pen) respectively, and bacterial culture growth of dentine samples collected from all (A, B, and C) the preparedcavities.

DESIGN

Three-arm, double-blinded, parallel group randomized trial. A centralized randomization, into three groups A, B, and C, used opaque envelopes containing names of diagnostic methods allocated to teeth in the trail.

SETTING

Restorative Dentistry clinics of a teaching hospital in northeastern Nigeria.

PARTICIPANTS

Ninety patients with dental caries in dentine. All 90 patients met the requirements for the study.

INTERVENTION

Carious lesions were excavated, and cavity preparation was performed via the visual-tactile method. Prepared cavities in groups B and C were assessed for residual caries with CDD and LF (DIAGNOdent Pen), respectively, by a blinded independent investigator. Dentine samples were obtained from all the prepared cavities (A, B, and C) and subjected to bacterial culture. Teeth were restored and follow-up was not required.

MAIN OUTCOME MEASURES

The presence or absence of residual caries staining by CDD and fluorescence by DIAGNOdent in prepared cavities of groups B and C, respectively; the presence or absence of bacterial culture growth for all three groups.

RESULTS

Ninety participants (mean age 31.6 ± 7.480), each with one tooth with a deep carious lesion were randomized. The visual-tactile method had a specificity of 100%, CDD had 100% sensitivity and 92.9% specificity, and DIAGNOdent had 100% sensitivity and 100% specificity when measured against bacterial cultures. The positive predictive value for CDD (50%) was half that for DIAGNOdent (100%). The negative predictive value was the lowest (90%) for the visual-tactile method. The accuracy was highest (100%) for DIAGNOdent. There was perfect agreement between the DIAGNOdent and bacteriological tests (kappa = 1.00), whereas the CDD had an above-random level of agreement (kappa = 0.63).

CONCLUSIONS

All three residual caries evaluation methods were efficient, independently, in detecting residual caries in prepared cavities. DIAGNOdent was the most specific of the tested modalities and had the highest agreement with the bacteriological confirmatory test.

TRIAL REGISTRATION

PanAfrican Clinical Trial Registry (PACTR202309545839091), registered on 1st September 2023.

摘要

背景

牙本质龋的治疗面临着平衡充分的龋去除以防止残留龋和过度去除健康牙本质的挑战。目前还没有可用于临床定义龋去除界限的诊断工具。本研究旨在确定视觉触觉、龋探测染料(CDD)和激光荧光(LF)设备在窝沟制备后诊断残留龋的效率。

方法

本研究在尼日利亚东北部一所教学医院的修复牙科诊所进行了一项三臂、双盲、平行组随机试验。个体化的牙本质龋损随机分配到三组残留龋诊断方法,A(视觉触觉)、B(CDD)和 C(LF)。所有龋损均采用视觉触觉法进行龋蚀和窝沟制备。主要观察指标为分别用 CDD 和 LF(DIAGNOdent Pen)评估组 B 和 C 制备窝沟中的残留龋,以及从所有(A、B 和 C)制备窝沟中收集的牙本质样本的细菌培养生长情况。

设计

三臂、双盲、平行组随机试验。采用中央随机化,将牙齿随机分为三组 A、B 和 C,使用包含诊断方法名称的不透明信封进行分组。

设置

尼日利亚东北部一所教学医院的修复牙科诊所。

参与者

90 名患有牙本质龋的患者。所有 90 名患者均符合研究要求。

干预措施

用视觉触觉法挖掘龋损,并进行窝沟制备。用盲法独立观察者分别用 CDD 和 LF(DIAGNOdent Pen)评估组 B 和 C 中的制备窝沟是否存在残留龋。从所有制备窝沟(A、B 和 C)中获得牙本质样本,并进行细菌培养。牙齿被修复,不需要随访。

主要观察指标

CDD 检测制备窝沟中残留龋的存在或不存在,LF(DIAGNOdent Pen)检测制备窝沟中残留龋的存在或不存在;三组中所有样本的细菌培养生长情况。

结果

90 名参与者(平均年龄 31.6±7.480),每人有一颗深龋牙被随机分组。视觉触觉法的特异性为 100%,CDD 的敏感性为 100%,特异性为 92.9%,LF 的敏感性为 100%,特异性为 100%,与细菌培养相比。CDD 的阳性预测值(50%)仅为 LF(100%)的一半。视觉触觉法的阴性预测值最低(90%)。LF 的准确性最高(100%)。LF 与细菌学检测之间具有完美的一致性(kappa=1.00),而 CDD 则具有高于随机水平的一致性(kappa=0.63)。

结论

所有三种残留龋评估方法在检测制备窝沟中的残留龋方面均有效。LF 是测试方法中最具特异性的方法,与细菌学确认试验具有最高的一致性。

试验注册

泛非临床试验注册中心(PACTR202309545839091),于 2023 年 9 月 1 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4497/11607968/c388d033a9e8/12903_2024_5243_Fig1_HTML.jpg

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