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引导组织再生术联合应用透明质酸或釉基质衍生物单瓣法治疗骨内缺损的 24 个月随机对照临床试验。

Healing of intrabony defects following regenerative surgery by means of single-flap approach in conjunction with either hyaluronic acid or an enamel matrix derivative: a 24-month randomized controlled clinical trial.

机构信息

Section of Periodontology, Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, 6 Caserta Street, 00161, Rome, Italy.

Department of Periodontology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.

出版信息

Clin Oral Investig. 2021 Aug;25(8):5095-5107. doi: 10.1007/s00784-021-03822-x. Epub 2021 Feb 10.

Abstract

OBJECTIVES

The aim of this randomized controlled clinical trial was to compare the clinical outcomes obtained in intrabony defects following regenerative periodontal surgery using the single-flap approach (SFA) in conjunction with either hyaluronic acid (HA) or enamel matrix derivative (EMD).

MATERIALS AND METHODS

Thirty-two intrabony defects in 32 healthy subjects were randomly assigned: HA (test group) or EMD (control group). Clinical attachment level (CAL), probing depth (PD), gingival recession (REC), and bleeding on probing (BOP) were recorded at baseline,12, 18, and 24 months after surgery.

RESULTS

At 24 months, both treatments resulted in statistically significant clinical improvements evidenced by PD-reduction and CAL-gain (p<0.001). The mean CAL-gain was 2.19±1.11 mm in the test and 2.94±1.12 mm in the control sites (p=0.067). PD-reduction was statistically significantly higher for the control group (4.5±0.97 mm) than the test group (3.31±0.70 mm), (p=0.001). CAL-gain ≤ 3 mm was observed in 87.5% and in 62.5% of the test and control sites, respectively. Test sites showed slightly lower REC values than the control sites. No statistically significant differences were found for BOP between treatments.

CONCLUSIONS

The present findings indicate that both treatments led to statistically significant clinical improvements compared to baseline, although the application of EMD resulted in statistically significantly higher PD-reduction compared to the use of HA.

CLINICAL RELEVANCE

The use of HA in conjunction with a SFA resulted in significant PD-reduction and CAL-gain, pointing to the potential clinical relevance of this material in regenerative periodontal surgery.

摘要

目的

本随机对照临床试验旨在比较使用单瓣法(SFA)联合透明质酸(HA)或釉基质衍生物(EMD)进行再生牙周手术后获得的骨内缺损的临床效果。

材料和方法

将 32 名健康受试者的 32 个骨内缺损随机分为 HA(实验组)或 EMD(对照组)。在基线、术后 12、18 和 24 个月记录临床附着水平(CAL)、探诊深度(PD)、牙龈退缩(REC)和探诊出血(BOP)。

结果

在 24 个月时,两种治疗方法均导致 PD 减少和 CAL 增加,具有统计学意义的临床改善(p<0.001)。实验组的平均 CAL 增加为 2.19±1.11mm,对照组为 2.94±1.12mm(p=0.067)。对照组的 PD 减少明显高于实验组(4.5±0.97mm 对 3.31±0.70mm)(p=0.001)。CAL 增加≤3mm 的分别占实验组和对照组的 87.5%和 62.5%。实验组的 REC 值略低于对照组。两种治疗方法之间在 BOP 方面无统计学差异。

结论

与基线相比,两种治疗方法均导致了统计学上显著的临床改善,尽管与 HA 相比,EMD 的应用导致了统计学上更高的 PD 减少。

临床相关性

HA 与 SFA 联合使用可显著降低 PD 和增加 CAL,这表明该材料在再生牙周手术中具有潜在的临床相关性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5be0/8342388/cc68de715278/784_2021_3822_Fig1_HTML.jpg

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