Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy. A Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Vertical Clinical Attachment (PAL-V) Gain 6 Months After Surgery
研究概览
简要总结
Study Hypothesis: The administration of 200 mg doxycycline once a day for 7 days after regenerative periodontal therapy of infrabony defects improves the results of therapy (clinical vertical attachment gains [CAL-V], bony fill) and reduces postoperative flap dehiscence and defect exposure.
In each of 90 patients one infrabony defect shall be treated by regenerative techniques (guided tissue regeneration [GTR], enamel matrix derivative [EMD]). Prior to , 6, 12, and 24 months after surgery clinical measurements (Plaque Index [PlI], probing depth [PD], vertical clinical attachment level [CAL-V], Gingival Index [GI]) and standardized radiographs are obtained.
详细描述
Patients From April 2007 until February 2009 all patients undergoing periodontal treatment at the Department of Periodontology, Center of Dental, Oral, and Maxillofacial Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt/Main and the Section of Periodontology, Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, University Hospital Heidelberg are screened for this study. Patients and methods of this study have been described in detail before. Thus only a brief description is provided.
The trial is approved by the Institutional Review Boards for Human Studies of the Medical Faculties of the Johann Wolfgang Goethe-University Frankfurt/Main (159/06) and the University of Heidelberg (ABmu-179/2006) as well as the German Federal Drug Authority (Bundesamt für Arzneimittel und Medizinprodukte). All participating individuals are informed on risks, benefit and the procedures of the study. All give written informed consent. The study is registered under the EudraCT-Nr. 2006-001367-36 and under the number NCT01030666.
Clinical measurements The following clinical parameters are assessed at six sites per tooth (mesiobuccal, midbuccal, distobuccal, distolingual, midlingual, mesiolingual) at baseline, 12, and 24 months after surgery: Gingival Index (GI), Plaque Index (PI), PD and CAL-V to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the CAL-V measurements, the cemento-enamel junction (CEJ) is used. If the CEJ is destroyed by a restoration the restoration margin (RM) serves as reference.
Radiographic examination Standardized radiographs are obtained of test teeth by modified film holders (VIP 2 Positioning, UpRad Corp., Fort Lauderdale, FL, USA). These are done routinely in the clinical setting, after antiinfective and immediately before surgical treatment. Intraoral size 0 and 2 dental films (Insight, Eastman Kodak Co., Rochester, NY, USA) are exposed using an x-ray source (Heliodent DS, Sirona, Bensheim, Germany) with 7 mA and 60 kVp and developed under standardized conditions (XR24pro, Dürr Dental GmbH, Bietigheim-Bissingen, Germany).
Radiographic evaluation All radiographs are evaluated by one examiner (LR) who is blinded to the clinical results and to the time point the particular radiographs had been taken. All radiographs are digitalized using a computer program (SIDEXIS nextGeneration 1.51, Sirona, Bensheim, Germany) and a flatbed scanner (Microtek ScanMaker 4, Microtek, Hsinchu, Taiwan) with 600 dpi resolution and 8 bit grey values. The image files are stored as TIFF files and analyzed using the above mentioned computer program (SIDEXIS nextGeneration 1.51, Sirona, Bensheim, Germany) and a 19' flat Screen (Totoku CCL 192 plus, Totoku Electric, Ueda, Japan).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (at least 18 years of age) with moderate to severe periodontal disease (chronic and aggressive periodontitis) to be recruited from the Dept. of Periodontology, Centre for Dental, Oral, and Maxillofacial Medicine, Hospital of the Johann Wolfgang Goethe-University Frankfurt/Main and from the Section of Periodontology, Dept. of Conservative Dentistry, Clinic for Oral, Dental, and Maxillofacial Diseases, University Hospital Heidelberg
- •completed initial periodontal treatment consisting of oral hygiene instruction, scaling and root planing under local anesthesia according the concept of full-mouth disinfection and re evaluation of the tissue response and the patient's plaque control 3 months later. Sites with infrabony defects and persisting pockets (PD > 5 mm and bleeding on probing, BOP) that occur at re evaluation or supportive periodontal treatment (SPT) are subjected to surgical therapy.
- •at least one radiographically detectable infrabony lesion
- •good physical health and with effective individual plaque control (Full-mouth-plaque score PCR </= 30% [O'Leary et al. 1972])
- •interproximal angular defects on single-rooted teeth or multi-rooted teeth without furcation involvement, radiographic infrabony component >/= 4 mm, vertical clinical attachment loss (CAL-V) > 6 mm and PPD >/= 6 mm
- •Only women in childbearing age (< 45 years) who provide contraception from screening to U2
- •informed written consent
排除标准
- •known allergies to tetracyclines or any components of the active drug or placebo
- •severe liver dysfunction
- •local or systemic antibiotic treatment during the last 3 months before surgery
- •ineffective individual plaque control (PCR > 30%)
- •kidney dysfunction
- •medication with barbiturate, carbamazepin, diphenyhydantoine, sulfonyl-urea, methoxyflurane, ciclosporin A, theophylline, isotretionin
- •chronic alcohol abuse
- •anticoagulative therapy
- •need for antibiotic endocarditis prophylaxis
- •pregnancy
- •lactation
研究组 & 干预措施
doxycycline
The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: Doxycycline (Drug)
doxycycline
The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: modified/simplified papilla preservation flap; scaling (Procedure)
doxycycline
The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: Prefgel/Emdogain (Biological)
doxycycline
The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: 0.12% chlorhexidine gluconate solution (Drug)
doxycycline
The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: Ibuprofen 400 mg (if necessary) (Drug)
doxycycline
The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: 1% chlorhexidine gluconate gel (if necessary) (Drug)
placebo
The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: Placebo (Drug)
placebo
The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: modified/simplified papilla preservation flap; scaling (Procedure)
placebo
The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: Prefgel/Emdogain (Biological)
placebo
The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: 0.12% chlorhexidine gluconate solution (Drug)
placebo
The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: Ibuprofen 400 mg (if necessary) (Drug)
placebo
The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
- modified/simplified papilla preservation flap; scaling
- Prefgel/Emdogain
- 0.12% chlorhexidine gluconate solution
- Ibuprofen 400 mg (if necessary)
- 1% chlorhexidine gluconate gel (if necessary)
干预措施: 1% chlorhexidine gluconate gel (if necessary) (Drug)
结局指标
主要结局
Vertical Clinical Attachment (PAL-V) Gain 6 Months After Surgery
时间窗: Baseline to 6 months after surgery
Difference of PAL-V measurement at baseline and 6 months. PAL-V were measured to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the PAL-V measurements, the cemento-enamel junction (CEJ) was used. If the CEJ is destroyed by a restoration (filling, crown) the margin of this restoration served as reference.
次要结局
- Radiographic Bony Fill 12 Months After Surgery (Reduction of Distance Cemento-enamel Junction [CEJ] to Bony Defect [BD])(Baseline to 12 months after surgery)
研究者
Peter Eickholz
Prof. Dr. med. dent.
Goethe University