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临床试验/NCT06149585
NCT06149585招募中不适用

Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
2
主要终点
Oral microbiome composition changes in patients who are dentate, edentulous, and have dental implants

研究概览

简要总结

The objectives of this study are to analyze the oral microbiome modulations occurring during the transition from partial (with some residual teeth) to full edentulous (without remaining teeth) status and implant placement in subjects affected by severe periodontitis; to evaluate if microbiome changes in relation to the used of different implant material/surface; and to assess the variance of the changes to determine the sample size for future longitudinal prospective studies.

详细描述

The introduction of dental implants has significantly changed the treatment approach for prosthetic rehabilitation of partially and edentulous patients. In the last decades an increasing number of patients have received implants for the replacement of missing teeth. Although dental implants have proved to be a very predictable treatment option, in the long term they are susceptible to biologic complications that may lead to implant loss. In particular, two major peri-implants conditions have been described: peri-implant mucositis and peri-implantitis. Peri-implant mucositis is an inflammatory condition of the peri-implant tissue without bone loss and is considered reversible once the biofilm is removed; Peri-implantitis is an inflammatory condition that affect the bone support of the implant and if untreated may lead to implant loss. The major etiologic factors involved in Peri-implantitis are: history of periodontitis, poor plaque control, and poor patient compliance. The high susceptibility to biologic complication of implants placed in partially edentulous patients with history of periodontitis has been demonstrated in several studies. Multiple studies demonstrated periodontal pathogens can transfer from teeth to implants. However, it is unclear whether the same occurs on implants placed in edentulous subjects that have lost their dentition due to periodontitis. Previous investigations have shown a significant reduction but not the complete elimination of putative periodontal pathogens following full mouth extractions. Most of the studies on microbial population around teeth and implants are based on assessing the presence or absence of putative pathogens. Limited information is available regarding the whole microbiome shift from dentate to edentulous status and the changes occurring around the implant crevice after implants are placed. The use of 16S RNA pyrosequencing has been recently introduced to study the oral microbiome in health and disease. More recently shotgun metagenomic sequencing was introduced which allows evaluation of all the genes in a microbial community thereby revealing information on community composition and also community functional capacity. Shotgun sequencing also allows tracking of strains using single nucleotide variants or gene-content assessments, allowing assessment of longitudinal changes in colonization. The purpose of this investigation is to assess the oral microbiome changes in subjects with terminal dentition due to periodontitis over the entire treatment period, including the shift from dentate status to edentulous and finally post-implant.

Patients diagnosed with terminal dentition due to periodontitis with the intention to replace the dentition with implant-supported/retained restorations will be invited to participate.

Visit 1 - Screening visit to evaluate patient qualification for the study. Inclusion-Exclusion criteria. Qualifying patients will be enrolled and will receive a full mouth examination including an assessment of PD, clinical attachment level (CAL), BoP, and furcation involvement.

Visit 2 - Baseline microbial sampling and Full mouth extractions. Pool microbial sampling will be performed before teeth extractions. An immediate denture may be delivered at this time.

Visit 3 - Diagnostics for Implant Placement 3-4 months after teeth extraction. Diagnostic appointments may include multiple visits for diagnostics setup, Cone-beam computed tomography (CBCT), and provisional denture adjustments prior to implant placement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • At least 21 years of age
  • Diagnosis of Stage III or IV periodontitis based on full mouth probing and full mouth x-rays
  • Planned for full mouth extraction and replacement by dental implants.
  • Rehabilitation with Implant supported restorations either maxilla and/ or mandible.
  • At least 2 implants available for examination.
  • No bone augmentation required.

排除标准

  • Conditions requiring chronic routine prophylactic use of antibiotics.
  • Conditions requiring prolonged use of steroids.
  • History of leukocyte dysfunction and deficiencies
  • Bleeding disorders
  • History of neoplastic disease requiring use of radiation or chemotherapy
  • Metabolic bone disorders
  • Uncontrolled endocrine disorder
  • Use of any investigational drug or device within the 30 day period prior to implant surgery.
  • 10. Alcoholism or drug abuse
  • Patient infected with HIV
  • Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.
  • Local Exclusion Criteria
  • Local inflammation
  • Mucosal disease such as erosive lichen planus
  • History of local irradiation therapy
  • Osseous lesion.
  • Active infection with suppuration or fistula track.
  • Persistent intraoral infection different than periodontitis

结局指标

主要结局

Oral microbiome composition changes in patients who are dentate, edentulous, and have dental implants

时间窗: Through study completion, an average of 24 months

To analyze the oral microbiome modulations through DNA analysis of microbial samples occurring during the transition from partial (with some residual teeth) to full edentulous (without remaining teeth) status and implant placement in subjects affected by severe periodontitis

Oral microbiome changes in two different implant platform types

时间窗: Through study completion, an average of 24 months

To evaluate if microbiome changes through DNA analysis of microbial samples in relation to the use of different implant material/surface

次要结局

  • Sample size(Through study completion, an average of 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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