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临床试验/NCT02049008
NCT02049008已完成4 期

Clinical, Microbiological and Immunological Effects of Antimicrobial Photodynamic Therapy on Non-surgical Treatment of Aggressive Periodontitis: a Double-blind Split-mouth Randomized Controlled Clinical Trial.

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Change from Baseline in clinical attachment level at +90 days.

研究概览

简要总结

The treatment of aggressive periodontitis (AgP) represents a challenge for clinicians, because there are no standardized protocols for efficient control of the disease. The aim of this study is to evaluate the effect of multiple applications of antimicrobial photodynamic therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in patients diagnosed with AgP. Twenty patients with a clinical diagnosis of AgP will be treated in a split-mouth design study to either aPDT associated with scaling and root planning (SRP) or SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will occur in four episodes (days 0, 2, 7 and 14). All patients will be monitored for 90 days. Clinical assessment of plaque index, probing depth, clinical attachment level and bleeding on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the nsPT. Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Gingival crevicular fluid samples will be collected (at baseline and 14, 30 and 90 after the nsTP) for evaluation the volume of fluid (Periotron) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex). Data obtained will be statistically analyzed.

详细描述

Non-Surgical Periodontal Therapy

Seven days prior to the non-surgical periodontal therapy, periapical radiographs will be taken from the whole mouth of all patients. They will be set in an oral hygiene program (OHP) according to their specific needs. In this program, patients will be instructed about an effective self-performed plaque control, including information about the Bass Technique (Bass, 1954) and interproximal cleaning with dental floss and interdental brushes. They will be also motivated to brush the dorsal surface of the tongue once a day and will receive a dentifrice that shall be used throughout the experimental period (Colgate Total®, Anakol Ind. Com Ltda - Brazil's Kolynos - Colgate Palmolive Co., Sao Bernardo do Campo, SP, Brazil). After the OHP, subjects will undergo the assessment of clinical periodontal parameters previously described and the collection of subgingival plaque and GCF in selected sites (baseline) will be performed. Shortly, patients will receive supragingival scaling and coronal polishing with prophy cup on all the teeth present in the oral cavity. The non-surgical periodontal therapy will initiate 7 days after the OHP and initial supragingival scaling. Within 24 hours, a specialist in Periodontics will perform supra and subgingival scaling and root planing of all teeth with periodontal involvement, using hand (Gracey Curettes, Hu-Friedy, Chicago, IL, USA) and ultrasonic instruments. The instrumentation will be performed on each quadrant until achievement of an adequate cleaning and root planing, which will be verified with a dental explorer. Individuals will receive professional prophylaxis biweekly during three months after the end of the nonsurgical periodontal therapy. On biweekly follow-up visits, patient's cooperation will be monitored by verifying the status of oral hygiene.

Antimicrobial photodynamic Therapy

After a full-mouth scaling and root planning (SRP), the periodontal pockets of teeth selected to receive antimicrobial photodynamic therapy (aPDT) will be irrigated with distilled water. Shortly thereafter, the dye will be applied (phenothiazine hydrochloride- 10mg/mL) from the bottom of the pocket. After 1 minute, irrigation will be performed with distilled water to remove the excess of dye. The stained area will be irradiated with a diode laser (660 nm and a 60 mW/cm²). Six sites per tooth under treatment will be irradiated (10 seconds/ site). The applications of aPDT will be repeated in the same way until the second week (days: 2, 7,14). Before the application, the supragingival plaque will be removed.

Each patient will be impressed with alginate in order to obtain models of the dental arches and elaborate a guide plate made of acetate. This plate will present grooves that will be used as references to standardize the insertion and tilt of the automated periodontal probe (Florida Probe System, Florida Probe Corporation, Gainesville, FL, USA). The visible plaque index for each patient, rated dichotomously (O'Leary et al. 1972), will be determined by the percentage of tooth surfaces with deposits of plaque stained with disclosing solution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • subjects with <35 years old;
  • a minimum of 20 teeth present;
  • two pairs of single-rooted teeth in opposite sides with proximal sites showing probing depth and clinical attachment level ≥ 5 mm.

排除标准

  • Positive history of antibiotic-therapy in the last six months;
  • Positive history of basic periodontal treatment in the last six months;
  • Systemic disease that can interfere with the progression of disease or response to treatment (eg, diabetes, immune disorders);
  • Extensive prosthetic involvement;
  • Need for antibiotic prophylaxis for performing routine dental procedures;
  • Use of anti-inflammatory drugs for long periods of time;
  • Pregnancy.

结局指标

主要结局

Change from Baseline in clinical attachment level at +90 days.

时间窗: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +90 days after the non-surgical periodontal therapy.

次要结局

  • Change from baseline in counts of 40 subgingival bacterial species at +30 and +90 days(Microbiological monitoring (at baseline and +30 and +90 days after the non-surgical periodontal therapy) using the checkerboard DNA-DNA hybridization)
  • Change from baseline in levels of IL-1β, IL-10 and TNF-alpha at +14 and +30 and +90 days(Immunological monitoring (at baseline, +14 and +30 and +90 days after the non-surgical periodontal therapy) using Luminex.)
  • Numbers of patients requiring additional periodontal treatment at +90 days.(Considering each group separately, it will be evaluate the number of patients presenting at least a site with PPD≥5 mm and positiveBOP at 90 days post-therapy.)

研究者

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

Michel Reis Messora

Ph.D.

University of Sao Paulo

研究点 (2)

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