跳至主要内容
临床试验/NCT04178291
NCT04178291Unknown不适用

Erythritol Powder Air Polishing as an Adjunct in Non-surgical Periodontal Therapy in the Management of Periodontitis: a Randomised Clinical Trial

University of Malaya2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年1月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
Changes in probing pocket depth (PPD).

研究概览

简要总结

Periodontal disease is an infection that causes inflammation and destruction of the tooth supporting structures, and if untreated, will eventually lead to tooth loss. Periodontal disease has been identified as a significant contributor to the global burden of oral disease. This disease is reported to be the sixth most prevalent disease globally. Periodontal disease has an association with diabetes, cardiovascular diseases and preterm low birth weight babies. Therefore, treatment of this disease is necessary. Treatment of periodontal disease involves mechanical removal of oral biofilm. Biofilm removal is initially carried out via non-surgical periodontal therapy, with subgingival debridement being one of the most important steps. According to the first European Workshop on Periodontology, subgingival debridement comprises subgingival instrumentation to disrupt and remove the oral biofilm. Subgingival debridement involves various techniques including hand instrumentation and ultrasonic instrumentation. Recently, treatment modality such as air polishing is also gaining momentum. Air polishing was reported to be more comfortable than conventional periodontal therapy. Besides, a number of studies had portrayed similar clinical outcomes with the use of air polishing in comparison to conventional periodontal therapy. However, there is no study evaluating the health economic aspect of these treatment modalities. Health economic evaluation is a valuable evaluation in intervention studies. Such evaluations provide information on the best way of using available resources in health care settings. For instance, advances in health care technology have resulted in an array of alternative treatment options. Unfortunately, such options tend to cost more than the existing therapeutic approaches. Therefore, economic evaluations will identify the worth of the new treatment options in comparison to the gold standard, in this case, comparing the adjunctive use of air polishing with conventional periodontal therapy. Besides focusing at patient reported outcomes and cost effectiveness of air polishing, this prospective, parallel, single-blinded, randomised controlled clinical trial is also planned to investigate the clinical and biological responses after the adjunct use of Erythritol Powder Air Polishing (EPAP) in addition to root surface debridement (RSD).

详细描述

Periodontal disease is an infection that causes inflammation of the tooth supporting structures, which results in the destruction of the periodontal ligament and alveolar bone, and eventually, tooth loss. The aetiology of the disease is oral biofilm. Therefore, the regular mechanical removal of biofilm, among others, is necessary to prevent and stop the disease progression. Biofilm and biofilm retentive calculus are removed via periodontal debridement. Subgingival debridement is an important procedure that is initially performed in the non-surgical periodontal therapy phase. According to the first European Workshop on Periodontology, subgingival debridement involves gently instrumenting subgingivally to disrupt and/or remove the biofilm. Various techniques are involved in subgingival debridement, with hand instruments and ultrasonic or sonic instruments being the most common, while modalities like air polishing are gaining momentum.

Mechanical periodontal debridement using hand instruments like curettes, sickles, hoes or files, and power driven instruments such as sonic or ultrasonic scalers, is generally known as root surface debridement (RSD). This modality is considered to be the gold standard of periodontal therapy. The usage of hand instruments has been advocated for their efficiency and the fact that it allows tactile sensation and operator control. However, various drawbacks from these instruments have been noted. Hand instruments and scalers are both technique sensitive, time consuming, and may cause irreversible hard tissue damage when used regularly. Besides, anatomical variations such as grooves, concavities and enamel pearls as well as deep pockets and furcation involvement, can influence debridement quality. Since periodontal therapy is performed regularly, being time efficient, acceptable to patient, and causing minimal tissue damage are important determinants. As such, treatment that causes minimal abrasion to root surface while being highly effective in biofilm removal would be a preferable choice.

One such treatment is air polishing. Air polishing was introduced in 1945 for the purpose of cavity preparation. Over time, its use expanded to periodontal debridement. Stain and biofilm are removed by the abrasive "slurry" which is formed by mixing together pressurised air, a jet of water and a stream of small particles. Sodium bicarbonate was the only abrasive powder available from the late 1970s until 2004. It is non-toxic and water soluble, with a mean size of up to 250μm. It has been shown to be safe and efficient to be

used on intact enamel surfaces. However, due to its abrasiveness, it could not be used on demineralised enamel surfaces. A study showed that regardless of parameters such as working time, powder and water setting, working distance, and angulation of the handpiece, substantial damage to the root occurs from sodium bicarbonate, concluding that it is contraindicated for use in exposed root surfaces. In order to overcome this problem, glycine based powders were then produced. In the in vitro study showed that glycine powder proved to have low abrasiveness towards cementum and dentine, while being efficient at plaque removal. The powder had a mean particle size of 45μm - 60μm, and was 80% less abrasive compared to sodium bicarbonate. More recently, erythritol powders have been used in air polishing. Erythritol is a sugar alcohol that is non-toxic, chemically neutral, and water soluble, and has been widely used as an artificial sweetener and food additive. Due to comparable physical properties to glycine and chemical characteristics allowing binding of antiseptic substances, it has been suggested for subgingival biofilm removal. Moreover, a recent study has shown erythritol to have an inhibitory effect on some periodontal bacteria, including P. gingivalis.

Advancements in air polishing devices have also occurred, mainly involving a disposable nozzle design to access the periodontal pocket directly, thus allowing the abrasive slurry to be delivered into moderate-to-deep periodontal pockets. The nozzle has a thickness of 0.7mm, which is within the diameter range of most periodontal probes, thereby allowing it to be inserted to the base of the pocket with minimal force. Besides, the new design resulted in a drop of pressure of the jet spray by 1 bar, thus reducing the risk of emphysema and allowing the nozzle to be used subgingivally.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 30-65 years old
  • Healthy or well controlled systemic diseases, including diabetes (HbA1c<7%) and hypertension (BP<140/90 mm Hg)
  • Diagnosed with moderate to severe periodontitis (Stage II and III) regardless of grade (Caton et al. 2017)
  • >20 remaining teeth

排除标准

  • Systemic conditions requiring antibiotic prophylaxis
  • Pregnant or breast feeding women
  • Immunosuppressive therapy
  • Immunocompromised such as HIV/AIDS patients
  • Periodontal therapy in the last 6 months
  • Antibiotic or anti-inflammatory therapy in the last 4 months
  • Known hypersensitivity to sugar alcohol (polyol)
  • Physical limitations or restrictions that prevent normal oral hygiene procedures
  • Heavy smoker who smokes ≥ 1 pack of cigarettes per day
  • Plaque score > 30%
  • Probing pocket depth > 6mm

结局指标

主要结局

Changes in probing pocket depth (PPD).

时间窗: 6 months

Probing Pocket Depth (PPD) at 6 sites: Distance of margin of free gingiva to base of the pocket measured in millimetre using UNC-15 periodontal probe.

次要结局

  • Changes in clinical attachment level(6 month)
  • Changes in recession(6 month)
  • Changes in Periodontal inflamed surface area(6 months)
  • Changes in full mouth bleeding score(6 months)
  • Changes in full mouth plaque score(6 months)
  • The ratio value of incremental Cost Effectiveness(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nor Adinar Baharuddin

Associate Professor

University of Malaya

研究点 (2)

Loading locations...

相似试验