Erythritol Air-polishing Versus Curette/Ultrasonic Debridement of Mandibular Furcation Lesions in Supportive Periodontal Therapy A 12-Month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- In 20 patients with grade II mandibular molar furcation defects, probing depth (PD) will be measured.
研究概览
简要总结
Background: To effectively disrupt microbial biofilm and remove dental calculus with minimal damage to the root surface and soft tissues with limited patient discomfort constitute a significant tenet of periodontal therapy. The aim of the present prospective 12-month study was to compare clinical and microbiological effects following an erythritol air-polishing vs. conventional mechanical debridement of furcation defects in a cohort of periodontal maintenance patients.
Methods: Twenty patients with grade II mandibular molar furcation defects volunteered to enroll in this study. In a split-mouth design, two furcation sites in each patient were randomly assigned to either receive subgingival debridement using erythritol air-polishing (test) or conventional ultrasonic/curette debridement (control) at baseline, and at 3, 6, 9 and 12 months. Probing depth, clinical attachment level and bleeding on probing were recorded at 3-month intervals. Subgingival microbiological samples obtained at baseline, 6 and 12 months were analyzed using checkerboard DNA-DNA hybridization. Discomfort from treatment was scored at 12 months using a visual analogue scale.
详细描述
INTRODUCTION.Traditionally, periodontal debridement is accomplished using curettes, sonic or ultrasonic scalers, all presenting comparable outcomes.1,2 However, periodic root instrumentation may lead to dental hard tissue3-6 and soft tissue damage,7 and sensitivity due to exposure of dentinal tubules.8-10 Air-polishing using low abrasive glycine or trehalose powder has been shown to reach similar clinical outcomes as hand and ultrasonic instrumentation, but with less hard tissue loss.11-16 Moreover, air-polishing provides superior outcomes relative to patient comfort and time efficiency.7,11,12,14 Recently, a low abrasive erythritol powder with comparable physical properties to glycine air-polishing powder was introduced for subgingival air-polishing.17 Erythritol, a non-toxic, chemically neutral and completely water-soluble polyol is widely used in food industry as an artificial sweetener. Two studies comparing conventional mechanical debridement with erythritol air-polishing, reported similar results in supportive periodontal therapy (SPT) relative to clinical and microbiological outcomes.18,19 Such observations are also reflected in a systematic review concluding that air-polishing systems as a monotherapy are comparable to conventional therapy in patients undergoing SPT in single- and multi-rooted teeth without furcations.20 Moreover, inhibitory effects on pathogenic bacteria including Porphyromonas gingivalis have also been observed.21 To the investigator's knowledge, no prospective studies investigating the efficacy of a low abrasive erythritol air-polishing system in molar furcation defects during SPT have been reported. The objective of this 12-month prospective study was to compare clinical and microbiological effects following an erythritol air-polishing system vs. conventional mechanical debridement of furcation defects in a cohort of periodontal maintenance patients.
METHOD AND MATERIALS. The study protocol and informed consent following the Helsinki Declaration of 1975 (version 2008) was approved by the Medical Research Ethics Committee (2016/793), University of Bergen, Norway. Participating subjects read and signed the informed consent prior to enrolling in the study.
Prestudy calibration and training. Two operators performed the clinical aspects of this study. Author TS, masked to treatment assignments, performed all clinical recordings and sampling, author IU performed all treatments.
Sample size. The sample size estimation was based on change in PD. A difference of 0.5 mm was considered clinically relevant.22 Standard deviation of the difference between repeated PD measurements from the intra-calibration exercise was 0.5 mm. A power analysis based on 20 subjects and with the level of significance (α) set to 0.05, resulted in 98.9% power to detect a true difference of 0.5 mm.
Treatments. Following baseline examination, mandibular jaw quadrants were randomized (coin toss) to either receive debridement using the erythritol powder/air-polishing system (test) or conventional ultrasonic/curette instrumentation (control) using a split-mouth study design. Sequence of treatments was randomized in a similar fashion. Treatments were delivered at baseline, and repeated at 3, 6, 9 and 12 months. Test sites thus received root debridement using the low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland ) applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS, Nyon, Switzerland). The hand piece was fitted with a nozzle for subgingival delivery directing the power/air jet perpendicular to the root surface at the water exit at the tip of the nozzle. The nozzle was inserted to the apical aspect of furcation sites with PD≥ 4 mm using striking movements over the furcation area for 5 sec.12 Sites adjoining the test site with PD≥ 4 mm were similarly treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Two operators performed the clinical aspects of this study. Author TS, masked to treatment assignments, performed all clinical recordings and sampling, author IU performed all treatments. All analyses were performed by a statistician (SAL) who had not taken part in data collection or treatments.
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received supportive periodontal therapy (SPT) every 3-6 months for 2-3 years following periodontal therapy.
- •Having bilateral non-mobile, fully erupted mandibular first, second or third molars with degree II furcation defects.
- •PD≥4 mm with bleeding or pus on probing. -
排除标准
- •Mobile mandibular molars, molars with clinical or radiographic evidence of supra-/subgingival calculus or apical pathology.
- •Use of systemic antibiotics within 6 months or SPT within 3 months of study.
- •Any current medical condition affecting periodontal treatment or use of the abrasive air-polishing device.
- •Subjects with diabetes, cancer, HIV/aids, acute infections, disorders that may compromise wound healing, or pregnant women.
结局指标
主要结局
In 20 patients with grade II mandibular molar furcation defects, probing depth (PD) will be measured.
时间窗: 12 months.
PD: The vertical distance from the gingival margin to the probable base of the pocket in mm.
In 20 patients with grade II mandibular molar furcation defects clinical attachment level (CAL) will be measured.
时间窗: 12 months.
CAL: The vertical distance in mm from the cemento-enamel junction or the margin of a dental restoration to the probable base of the pocket.
次要结局
- Gingival crevicular fluid (GCF).(12 months.)
- Bleeding on probing (BoP).(12 months.)
- Visual analogue scale (VAS).(12 months.)
研究者
Knut N. Leknes
Professor
University of Bergen
