Treatment of Non-contained Infrabony Defects With Enamel Matrix Derivative Alone or in Combination With HA/β-TCP Graft: a 12-month Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Clinical Attachment Gain
研究概览
简要总结
Background: The use of Enamel Matrix Derivative (EMD) when dealing with non-contained defects may be limited, as EMD does not maintain a space itself. It has been proposed the use of combined therapy, using a bone graft in combination with EMD to avoid the collapse of the flap into the bony defect during the healing time. Therefore the aim of this study is to evaluate the clinical and radiological healing response of non-contained infrabony defects following treatment with a combination of EMD and Biphasic calcium phosphate (BC) or EMD alone.
Methods: Fifty-two patients with at least 1 infrabony defect > 3mm in depth with a probing pocket depth ≥ 6mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic parameters were evaluated at baseline, 6 and 12 months after surgery. To standardize the procedure an acrylic stent and a millimetre radiographic grid were used. The primary outcome was the change in clinical attachment level (CAL).
Results: Analysis of the data demonstrated a statistically significant difference from baseline within each group (p<0.05), showing a difference in clinical and radiographic parameters at 6 and 12 months for both EMD/BC and EMD alone. However, there were no statistically significant differences between treatment groups.
Conclusions: It was concluded that the treatment of non-contained infrabony defects with EMD, with or without BC, resulted in statistically significant better results after 12 months when compared to baseline measurements. In contrast, the combined approach did not result in a statistically significant improvement.
详细描述
This is a prospective randomized double blind clinical controlled trial (RCT). Fifty-two systemically healthy adult patients (19 females and 33 males) ranging in age from 35 to 70 years of age, with moderate to advanced chronic periodontitis with at least 1 infrabony defect being >3mm in depth were included. Patients were recruited and treated at the Department of Periodontology dental clinic from the Universitat Internacional de Catalunya, Barcelona, Spain. The sample size calculation was based on a previous pilot study in 10 patients in which differences in between groups where set at 1mm in CAL gain as the primary outcome, with an alpha error of 0.05 and a beta error of 0.9. Thus, the sample size was established for 52 patients including dropouts. The Ethics Committee at the International University of Catalonia (UIC) approved the study design with the code PER-ECL-2011-04-CM. This RCT is registered and follows the CONSORT guidelines as well as the Helsinki declaration for human research. Prior to the initiation of this study, an informed consent was obtained from each patient after explaining the nature of the investigation.
Treatment procedures:
Initial periodontal therapy consisted in oral hygiene instructions until the patient achieved high standards of oral hygiene (modified O'Leary plaque score < 20%), scaling and root planning under local anesthesia and occlusal adjustment if necessary. Four weeks after the completion of phase I therapy, a re-evaluation was performed to confirm the inclusion of the subjects in this clinical research. Probing pocket depth, attachment level, mobility, bleeding on probing and plaque index were assessed. Teeth with mobility greater than class I (Miller 1950) were splinted to adjacent teeth with a twisted wire and light-cured resin.
Before proceeding with the surgical treatment, cast models were obtained from an alginate impression to fabricate an acrylic resin occlusal to standardize clinical measurement with the periodontal probe (Hui-fredy CP-8). The occlusal stent was fabricated using the technique described by Lekovic.
Photographs and standardized reproducible intraoral digital radiographs were obtained from each operated site. The film holder was modified by placing a registration material (Optosil®) on the bite blocks to index the dentition. A paralleling cone technique (7mA-60kV/20ms) was used. A radiopaque millimeter grid was positioned over the radiograph to assess the radiographic measurements. Both the occlusal stent and the radiographic bite blocks with the millimeter grid provided a well-defined and reproducible measurement at each defect and at each examination time point
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
- Triple (Participant, 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
- 是
入选标准
- •subjects in treatment for periodontal disease with no systemic diseases or conditions that could influence the therapy outcome
- •not taking any medication that would affect periodontal healing
- •high standards of oral hygiene (PI <20%)
- •compliance with the maintenance program
- •presence of at least 1 infrabony defect with a probing depth ≥6mm after reevaluation of the hygienic phase and an infrabony component of ≥3mm as detected on radiographs, with any angulation, and exhibiting a 1 or 2 wall intrabony defect
- •presence of at least 2mm of keratinized tissue on the buccal aspect of the selected tooth and
- •teeth have to be vital or properly treated endodontically.
排除标准
- •subjects with any debilitating systemic disease or medication that could affect the periodontium
- •heavy smokers (>10 cigarettes/day)
- •teeth with class II or III furcation involvement
- •mobility > class 2
- •strict or predominantly 3-wall defects
结局指标
主要结局
Clinical Attachment Gain
时间窗: Baseline to 12 months
Clinical attachment will be recorded in millimeters with a periodontal probe. Differences between baseline and 12 months will be calculated. Measurements will be performed by a masked and calibrated investigator with the aid of a positioning stent over teeth to obtain reproducible measurement in each time point.
次要结局
- Probing pocket depth reduction(Baseline to 12 months)
- Radiograph bone fill gain(Baseline to 12 months)
研究者
Meritxell Losada Martínez
DDS, MS, Associated Professor
Universitat Internacional de Catalunya