Clinical trials in periodontal therapy

The success of periodontal therapy is evaluated not only after the termination of the comparatively short active treatment phase, but also at regular intervals during the extended maintenance phase. The main objectives of the active treatment include: (1) elimination of the inflammatory lesions present in the periodontium (2) reduction of probing pocket depth and (3) improvement of attachment levels, while the aim of the maintenance phase of therapy is the prevention of disease recurrence. Elimination of the inflammatory lesions in the periodontium is accomplished by meticulous plaque and calculus removal performed either as a single measure or combined with one of several different surgical treatment modalities. Findings from clinical trials have demonstrated that it is not the technique - nonsurgical-surgical - used during basic therapy, but the degree of root debridement accomplished that seems to be the determining factor for success in terms of resolution of periodontitis. Furcation involved premolars/molars constitute a problem with respect to effectiveness of therapy. Reliable research data describing treatment effects in the furcation regions of multirooted teeth are scarce. As a result of the elimination of the inflammatory lesions the periodontal tissues will offer more resistance to probing. This is clinically identified as probing pocket depth reduction, attachment level imrpovements and recession of the marginal gingiva. Research findings reveal that surgical and nonsurgical methods are almost equally effective in these respects. The concept that surgical methods which include resective measures will cause more gingival recession than non-resective measures should be questioned. Long-term clinical trials have demonstrated that patients who, following active treatment, are enrolled in carefully supervised plaque control programs only occasionally show signs of disease recurrence, while in this respect non-monitored patients frequently display signs of recurrent disease. It is suggested that the long-term effect of periodontal therapy is more related to the quality of the maintenance care program than the techniques utilized during active therapy.     

Selective outcome reporting bias is highly prevalent in randomized clinical trials of nonsurgical periodontal therapy

Selective outcome reporting (SOR) is a type of bias that can compromise the validity of results and affect evidence-based practice. SOR can overestimate the effect of an intervention and lead to conclusions that a treatment is effective when it is not. This study aimed to investigate the prevalence of SOR in publications of RCTs on nonsurgical periodontal therapy (NSPT) and to verify associated factors. The protocols were searched and selected on the www.clinicaltrials.gov platform up to January 16, 2022. Corresponding publications were identified, and data extraction and discrepancy analysis were performed. The risk of bias was assessed according to the RoB2 tool. One hundred forty-five studies (174 publications) were included. The prevalence of SOR was 49.7% and was unclear in nearly one third of studies (27.6%). Only 31.7% of the primary outcomes were completely described in the publications. The overall risk of bias was high in 60% of the included studies. SOR was associated with statistical significance (p < .001), and multiple publications of the same study (p = .005). Our study demonstrated the high prevalence of SOR, highlighting the need to improve the quality of reporting of RCTs on NSPT studies.     

Vector超声系统对牙周炎维护期患者的疗效观察和疼痛感受评价

目的本研究应用Vector超声系统、手工刮治和常规超声系统对慢性牙周炎患者维护期的牙周袋进行治疗,以比较不同治疗方法的临床疗效和患者的疼痛程度。方法选择26例慢性牙周炎维护期的患者,其全口四个象限每个象限至少各有2颗牙齿,其邻面至少有一位点探诊深度≥4mm,有探诊出血,根据随机表将四个象限随机分入手工刮治组、传统超声治疗组（赛特力组）、Vector摩擦剂组和Vector抛光剂组进行龈下刮治。记录基线和治疗后3个月时,入选位点的菌斑指数、牙周探诊深度、临床附着丧失、出血指数及刮治当时的疼痛程度VAS值。结果对于牙周炎维护期患者,Vector摩擦剂组、Vector抛光剂组的治疗效果和手工刮治组、赛特力组相同,牙周探诊深度、临床附着丧失和出血指数在治疗后都有明显改善,同时患者在治疗中的疼痛程度明显小于常规的手工刮治和超声刮治。结论Vector超声系统为牙周炎维护期患者的复查复治提供了一个新的有效手段,有利于增加患者的依从性。     

两种治疗仪在牙周基础治疗中的临床疗效和患者疼痛感受的比较

目的 比较牙周炎患者对两种超声治疗仪在牙周基础治疗中的临床疗效及患者疼痛感受的差异,以期为临床提供参与.方法 选择38例轻、中度牙周炎患者,对患者口内一、四象限用奇数、偶数随机法选择A(Vector治疗仪,德国D(U)RR齿科公司)或B(Suprasson P5 Newtron(R)超声多功能牙科治疗仪,法国赛特力公司)超声治疗仪进行治疗,第2天对二、三象限使用另一系统进行治疗.治疗结束后即刻用视觉模拟评分法(visual analogue scale,VAS)对患者行疼痛评估.治疗前及治疗后1个月检测菌斑指数(plaque index,PLI)、探诊出血(bleeding on probing,BOP)和探诊深度(probing depth,PD)等各项临床指标.结果 用两种超声系统行牙周基础治疗后,患者PLI、BOP和PD均较术前明显改善(P<0.01);两者BOP和PD的改变差异无统计学意义(P>0.05),与B治疗仪相比,A治疗仪治疗区域的PLI明显改善(P<0.05).A、B治疗仪在牙周基础治疗中患者主观感受疼痛VAS值分别为(22.5±7.5)mm和(37.2±11.3)mm,前者约为后者疼痛值的60%,两者差异有统计学意义(P<0.01).结论 在轻、中度牙周炎牙周基础治疗过程中,A、B两种超声治疗仪均疗效确切,A治疗仪能明显减轻患者在牙周治疗过程中的疼痛感.     

Controlled clinical trials in periodontal disease by general practitioners.

The general practitioner with loyal and regular patients is in a good position to undertake long-term clinical trials of periodontal treatment. Ethically, these should be comparisons of agents or procedures acknowledged to be beneficial but lacking confirmation of the long-term effects. Standardized bite-wing radiographs can represent a valuable record in this type of study.     

A clinical study to assess the breath protection efficacy of denture adhesive

This randomized and controlled, examiner-blind, 3-period, crossover clinical trial was designed to determine the effect of an experimental denture adhesive, a marketed denture adhesive (European Fixodent( Fresh), or no denture adhesive on the breath odor of 37 adults wearing full maxillary and mandibular dentures. Breath quality was measured at baseline and at 3 and 6 hours after the start of each treatment period via monitoring of volatile sulfur compounds (VSCs) using a halimeter and second-person organoleptic grading. A 48-hour washout phase separated treatment periods. There were no statistically significant differences in VSCs between any of the treatment regimens over 6 hours. Both the denture adhesive treatments were superior in breath quality improvement in organoleptic scores compared to no denture adhesive at 3 and 6 hours (p=0.0001). This research demonstrates the ability of both an experimental and marketed denture adhesive to deliver superior second-person breath benefits relative to no adhesive. The results indicate that Fixodent denture adhesives provide the denture wearer with a noticeable improvement in breath.     

Ineffectiveness of ozone therapy in nonsurgical periodontal treatment: a systematic review and metaanalysis of randomized clinical trials

Clinical Oral Investigations - This systematic review (SR) aimed at assessing the adjunctive clinical effect of ozone therapy (OT) on nonsurgical periodontal treatment. Articles published prior to...     

The efficacy of clinical indices in determining periodontal status]

The accuracy and reproducibility of a number of clinical indices used in assessment of the status of periodontal tissues was evaluated in clinical examinations of 240 students. The Green-Vermillion index and the CDL periodontal index were found the most accurate and reproducible, their efficacies ranging within 86-97%.     

可摘式牙周夹板修复治疗牙周炎的临床效果分析

目的：评价可摘式牙周夹板对牙周炎伴牙列缺损患者的修复效果。方法：选取40例,随机分为2组,每组20例。两组患者行牙周基础治疗后,分别采用可摘式牙周夹板修复和可摘局部义齿修复,观察并记录不同时段各相关牙周指数。结果：可摘式牙周夹板组修复后24个月时菌斑指数（ plaque index,PLI）和出血指数（ bleeding in-dex,BI）较修复前增加（P＜0.05）;但修复后12个月和24个月时牙周探诊深度（periodontal probing depth,PD）较修复前下降,差异均有统计学意义（P＜0.05）。可摘局部义齿修复组修复后12个月和24个月时均出现PLI、BI和PD较修复前明显增加（P＜0.05）。结论：可摘式牙周夹板可改善牙周炎伴有牙列缺损患者的牙周状况,其修复疗效优于可摘局部义齿。     

Toward strategies for the analysis of periodontal disease clinical trials

We consider design, analysis and regulatory issues relating to clinical trials in periodontal disease and identify complications commonly associated with such studies. Alternative statistical procedures that can be used for the analyses of data from periodontal research are reviewed and a case study of the analysis of a Phase II periodontal disease clinical trial is provided to illustrate the use of one of these procedures.     

Clinical versus statistical significance as they relate to the efficacy of periodontal therapy

BACKGROUND: The author discusses the shortcomings of using statistical significance testing as a method to infer that results of periodontal clinical trials are clinically meaningful. To compensate for these deficiencies, he also identifies criteria and periodontal parameters that can be used to reflect clinically significant outcomes. TYPES OF STUDIES REVIEWED: The author searched the medical and dental literature to identify commentaries that addressed the problems associated with interpreting statistical significance testing, or hypothesis testing, and defining clinical significance. RESULTS: The limitations of statistical significance testing related to identifying clinically significant changes include failure to indicate if the detected differences between variables in test and control groups are large or important. After reviewing various definitions of the term "clinical significance," the author reviews and proposes a comprehensive working definition of it. Regarding the efficacy of periodontal therapy, he delineates the advantages and limitations of specific criteria (such as absolute values, cut points) that can be used to define clinical significance. CLINICAL IMPLICATIONS: The author suggests that clinically significant results should be defined before initiating a study and statistical significance testing should be used to validate that findings did not occur by chance. This would help place the importance of clinical data into perspective, and it would enhance clinicians' ability to select the most appropriate therapies for particular sites in periodontal patients.