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临床试验/NCT03316937
NCT03316937已完成不适用

Comparison of the Effect of Teflon vs Non-Teflon Hand Scalers in the Maintenance of Peri-Implant Tissue: A Randomized Clinical Trial

University of Manitoba2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Degree of surface roughness

研究概览

简要总结

The buccal and lingual surface of the 23 participants' crowns will be randomly assigned to receive scaling and root planing with either Teflon scalers, or non-Teflon scalers after implant crown delivery. Each patient will act as their own control.

Patients will receive scaling and root planing at 3, 6, 9 and 12 months by a calibrated dental hygienist. All surfaces of the implant will be debrided for 1 minute using a transversal movement. Each patient will receive oral hygiene instructions by the hygienist at the end of each maintenance therapy appointment. The participants will be instructed to use a Modified Stillman brushing technique twice per day and cross shoe shine flossing motion once per day. Each patient will be provided with a three-month home care kit with dental aids. These aids will consist of toothpaste, a toothbrush and implant floss.

Measurements will be taken at 0, 3, 6, 9 and 12 months by a calibrated periodontal resident. The parameters assessed at the implant site and patient level will be modified plaque index (IPI) by Mombelli, modified gingival index (IBOP) by Mombelli, implant probing depths (PD) at six sites, presence of keratinized gingiva (KT), recession (REC), Full mouth plaque index (FPI) and Full mouth bleeding on probing (FBOP).

The Peri-implant Crevicular Fluid will be collected at 0, 3, and 12 months by isolating the implant site from saliva and introducing Periopaper strips into the buccal, mesial, distal and lingual sites of the implant sulcus for 30 seconds. The strips will be placed in a sealed Eppendorf tubes and transported by portable freezer to the laboratory where they will be stored at -86 degrees Celsius. The Periopaper samples will be treated for the detection and quantification of the following cytokines: Interleukin-2, Interleukin-4, Interleukin-6, Interleukin-8, Interleukin-10, Tumor Necrosis Factor alpha and Interferon gamma.

Periapicals will be taken at baseline and 12 months. All radiographs will be standardized.

After 12 months, the implant crown will be removed and the implant crown's surface alterations will be evaluated using atomic force microscopy (AFM) using the RA, or average roughness, and the RZ, or mean roughness depth, scores. The implant crown surface will then be repolished/reglazed and delivered back to the patient's mouth. Crowns will be evaluated before delivery to determine adequate level of smoothness.

Based on the presence of cytokines in the Peri-implant Crevicular Fluid, the degree of surface alterations, the modified plaque index, implant probing depths, full mouth plaque index, and full mouth bleeding on probing, we can determine if scratching affects the inflammation around the screw retained dental implant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • 未提供

排除标准

  • patients on corticosteroids
  • patients who have used antibiotics within the preceding 3 months
  • patients with uncontrolled diabetes mellitus
  • patients on daily nonsteroidal anti-inflammatory drugs
  • patients who are smokers.

研究组 & 干预措施

Teflon Scaler

Experimental

The buccal and lingual surface of the 23 participants' crowns will be randomly assigned to receive scaling and root planing with either Teflon scalers, or non-Teflon scalers after implant crown delivery. Each patient will act as their own control.

干预措施: Types of scalers (Procedure)

Non Teflon Scaler

Experimental

The buccal and lingual surface of the 23 participants' crowns will be randomly assigned to receive scaling and root planing with either Teflon scalers, or non-Teflon scalers after implant crown delivery. Each patient will act as their own control.

干预措施: Types of scalers (Procedure)

结局指标

主要结局

Degree of surface roughness

时间窗: 12 months

The implant crown's surface alterations will be evaluated using atomic force microscopy (AFM) using the average roughness (Ra) and the mean roughness depth (Rz), scores. Crowns will be evaluated before delivery to determine adequate level of smoothness. For our study, Ra and Rz should range from 0.1µm to 0.5µm. Higher values represent more scratching.

次要结局

未报告次要终点

研究者

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

Dr. Dayna Roemermann

Principal Investigator - Periodontics Resident

University of Manitoba

研究点 (2)

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