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TMJ 关节镜下透明质酸治疗:一项 12 个月的随机临床试验。

TMJ arthroscopy with hyaluronic acid: A 12-month randomized clinical trial.

机构信息

Department of Conservative Dentistry and Bucofacial Prosthesis, Complutense University of Madrid, Madrid, Spain.

Department of Dental Clinical Specialties, Complutense University of Madrid, Madrid, Spain.

出版信息

Oral Dis. 2021 Mar;27(2):301-311. doi: 10.1111/odi.13524. Epub 2020 Jul 25.

Abstract

OBJECTIVES

To determine the effects of hyaluronic acid (HA) as an adjunct to temporomandibular joint (TMJ) arthroscopy, relative to standard TMJ arthroscopy, in Wilkes stage-III and stage-IV patients.

METHODS

A randomized clinical trial design was utilized (ClinicalTrials.gov NCT04110587). 51 patients were allocated to a TMJ arthroscopy (n = 25) or a TMJ arthroscopy plus HA (n = 26) group. Visual analog scale joint pain scores, maximum mouth opening (MMO), and muscle pain were measured at baseline, and at 3, 6, 9, and 12 months. Disk position on magnetic resonance imaging was evaluated at baseline and 12 months. Oral health-related quality of life (OHRQoL) was assessed at baseline, and at 6 and 12 months.

RESULTS

No group differences were observed in clinical or radiographic measurements (p ≥ .05). The results do not indicate any benefit of HA as an adjuvant therapy to arthroscopy during follow-up months 3-12. TMJ arthroscopy improved OHRQoL at 6 and 12 months (Oral Health Impact Profile-14 questionnaire scores of -14.59 and -14.27, 95% confidence intervals = -17.55 to -11.63 and -17.27 to -11.27) respectively, as well as pain and MMO, at all follow-up time points (p < .001).

CONCLUSIONS

A beneficial effect of HA injection during TMJ arthroscopy after the 3-month follow-up was not observed.

摘要

目的

确定透明质酸 (HA) 作为颞下颌关节 (TMJ) 关节镜检查的辅助手段,相对于标准 TMJ 关节镜检查,在 Wilkes Ⅲ期和Ⅳ期患者中的效果。

方法

采用随机临床试验设计(ClinicalTrials.gov NCT04110587)。将 51 例患者分配至 TMJ 关节镜检查组(n=25)或 TMJ 关节镜检查加 HA 组(n=26)。在基线时、3、6、9 和 12 个月时测量视觉模拟量表关节疼痛评分、最大张口度 (MMO) 和肌肉疼痛。在基线和 12 个月时评估磁共振成像上的盘位置。在基线时、6 个月和 12 个月时评估口腔健康相关生活质量 (OHRQoL)。

结果

在临床或影像学测量方面,两组间未观察到差异(p≥.05)。结果表明,在随访的 3-12 个月期间,HA 作为关节镜检查的辅助治疗没有任何益处。TMJ 关节镜检查在 6 个月和 12 个月时改善了 OHRQoL(Oral Health Impact Profile-14 问卷评分分别为-14.59 和-14.27,95%置信区间分别为-17.55 至-11.63 和-17.27 至-11.27),以及所有随访时间点的疼痛和 MMO(p<.001)。

结论

在 3 个月的随访后,在 TMJ 关节镜检查中注射 HA 并未观察到有益效果。

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