Evaluation of Antimicrobial Photodynamic Therapy in Multiple Applications as a Coadjuvant in the Surgical Therapy of Access to Scaling in Patients With Advanced Chronic Periodontitis
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
- to evaluate clinical attachment level
研究概览
简要总结
Chronic periodontitis is an infectious disease resulting in inflammation of the teeth support structures, progressive periodontal attachment loss and bone loss. The aim of this study is to evaluate the effects of antimicrobial photodynamic therapy (TFDA) in multiple applications as an adjunct to surgical periodontal therapy in patients with generalized severe chronic periodontitis. A total of twenty patients will be submitted to this split-mouth trial, receiving initial periodontal basic nonsurgical treatment that is scaling and root planing. After the sites are indicated for surgical therapy, they receive surgical access therapy associated with scaling and root planing and TfdA using the treatment protocol during periods of 0, 7, 14 and 30 postoperative days, or only surgical access therapy associated with scaling and root planing. As protocol, TfdA will be used laser light source 660nm wavelength in combination with phenothiazine, a photosensitizer with 10 seconds of exposure per site during surgery and 60 seconds in other applications. All patients will be oral hygiene care and follow-up for 90 days. In the baseline period, basic post-therapy, 30 and 90 days after surgical therapy will be performed the clinical evaluation of plaque index, depth of probing pocket, level of clinical insertion relative and bleeding on probing, beyond the collection plate samples subgingival 40 for counting microbial species using the method of DNA-DNA hybridization checkerboard. For the same periods are also collected samples of gingival crevicular fluid for evaluating fluid volume (Periotron) and the levels of Interleukin 1 beta, Interleukin 10, MMP-8, tumor necrosis factor alpha, RANK-L and Osteoprotegerin (OPG). The data are statistically analyzed with the tests to the sample.
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.
Surgical Periodontal Therapy
The flap operations are performed 8 weeks after the start of the basic preparation. Patients will be monitored clinically and sites that present PS ≥ 5mm and SS presence will undergo surgical therapy scraping retail. Surgical procedures will be performed by a specialist in Periodontics. Initially patients will be subjected to extra-oral antisepsis with chlorhexidine 2% and intraoral through mouthwash with chlorhexidine 0.12%. The region to be operated infiltrative receive local anesthesia with lidocaine 2% solution, and 1: 100,000 epinephrine. The following will be performed intra-sulcular incision with a scalpel blade at 15C covering the site with PS ≥ 5mm and the adjacent teeth. A mucoperiosteal flap will be performed until the exposure of the bone crest and subgingival deposits of calculation and / or granulation tissue are removed by conventional Gracey curettes with RAR and Mini Five, numbers 5/6, 7/8, and 11/12 13/14 (Hu-Friedy, Chicago, IL, USA) and ultrasonic devices. Shortly after completion of the RAR starts to tfdA the operated region in the selected adjuvant therapy for this group. Completed therapy, the flap will be positioned in the same place of origin and stabilized with simple sutures through wire Vicryl 5-0. In order to avoid painful symptoms will be prescribed analgesics (Paracetamol 750mg, 01 tablet every 6 hours for 48 hours). They will also be prescribed soft oral rinses with 0.12% chlorhexidine digluconate, 2 times a day for 14 days. The sutures are removed after 7 days. Being performed weekly supragingival plaque control in the first month and monthly until completing 3 after surgical intervention months.
Antimicrobial photodynamic Therapy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with >35 years old
- •A minimum of 15 teeth present
- •One pair of posterior 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
研究组 & 干预措施
Photodynamic Therapy and SRP
Procedure/Surgery: Photodynamic Therapy After a surgical access, 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). Teeth with furcation lesion will increase over 60 seconds into the lesion. Before the application, the supragingival plaque will be removed.
Treatment with TFDa in the Test Group maintained the protocol of applications in the periods of 2, 7 and 14 days post-surgical intervention.
干预措施: Photodynamic Therapy (Radiation)
SRP and Sham Photodynamic Therapy
Procedure/Surgery: Sham Photodynamic Therapy After a surgical access, the periodontal pockets of teeth selected will receive a simulation of antimicrobial photodynamic therapy (aPDT): irrigation with distilled water and simulated laser application. Before the application, the supragingival plaque will be removed.
干预措施: scaling and root planing (Other)
结局指标
主要结局
to evaluate clinical attachment level
时间窗: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +120 days after the surgical periodontal therapy.
Change from Baseline in clinical attachment level at +120 days
次要结局
- counts of 40 subgingival bacterial species(Microbiological monitoring (at baseline and +30 and +120 days after the surgical periodontal therapy) using the checkerboard DNA-DNA hybridization)
- patients requiring additional periodontal treatment(Considering each group separately, it will be evaluate the number of patients presenting at least a site with PPD≥5 mm and positiveBOP at 120 days post-therapy)
研究者
Sergio Luis Scombatti de Souza
Dr
University of Sao Paulo
