Comparative Microbiome Analysis of Dental Biofilm on Two High-Density PTFE Membranes for Socket Preservation: A Molecular Evaluation of Streptococcus and Periodontopathogenic Species
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Scanning electron microscopy analaysis (SEM)
研究概览
简要总结
The goal of this clinical trial is to evaluate how different types of high-density polytetrafluoroethylene (d-PTFE) membranes impact dental biofilm accumulation and composition in patients undergoing socket preservation following tooth extraction. The main question it aims to answer are:
Does the type of d-PTFE membrane influence the diversity and composition of the dental biofilm in vivo? Therefore, the investigators will compare two types of d-PTFE membranes (Permamem® and Cytoplast™) to examine their respective effects on microbial colonization.
Participants will:
- Undergo tooth extraction followed by socket preservation with either the Permamem® or Cytoplast™ membrane, randomly assigned.
- Have biofilm samples collected from the membranes after 4 weeks for analysis through SEM, RT-PCR, and NGS methods.
- Return for follow-up visits, including a six-month check to evaluate healing progress and to continue with implant-prosthetics rehabilitation.
详细描述
This study was organized as a randomized controlled clinical trial, recruiting patients from a general population of oral surgery office. Participant are indicated for at least one tooth extraction and subsequent implant placement due to the failure of conventional therapies to preserve affected teeth. Before entering the study, all participants must provid informed consent after reviewing study details.
Out of 56 participants initially screened, 39 participants met the inclusion criteria and were randomly allocated to one of two study groups via a web-based randomization tool (https://www.randomizer.org/). In both groups, a socket grafting procedure will be performed immediately following tooth extraction, using a composite bone graft comprising 50% autogenous bone and 50% bovine xenograft (cerabone®, botiss biomaterials GmbH, Zossen, Germany), after the participants were randomly assigned to the following groups:
- M1: In the group M1, the grafted site was covered with a d-PTFE membrane (Permamem®, botiss biomaterials GmbH, Zossen, Germany), and
- M2: In the group M2 the grafted site was covered with an alternative d-PTFE membrane (Cytoplast™, Osteogenics Biomedical, Texas, USA).
No non-intervention control group was included in this study, as previous research studies have demonstrated that the absence of socket preservation leads to significantly greater volume loss compared to when preservation techniques are applied.
After tooth extraction and curettage, the integrity of the buccal bone wall will be assessed. Then, the base and central portion of the socket will be filled with autologous bone, while the remaining upper portion (up to the level of the buccal wall) will be filled with a 50:50 mixture of bovine bone biomaterial and autologous bone. A d-PTFE membrane will be positioned beneath the buccal and lingual soft tissue flaps, covering 3-5 mm of the upper bone wall. The central portion of the membrane will remain exposed, with no attempt to achive primary wound closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients indicated for tooth extraction due to:
- •Deep caries lesions with chronic periapical periodontitis
- •Fractures of the tooth crown and/or root
- •Other conditions preventing conventional therapy
- •Age between 18 and 60 years
- •Physically and mentally healthy
- •Patients who understand the study protocol and provide informed consent
排除标准
- •Patients with any absolute contraindications for implant-prosthetic therapy (e.g., uncontrolled systemic diseases)
- •Systemic conditions including:
- •Uncontrolled diabetes
- •Osteoporosis or osteopenia
- •Vitamin D deficiency
- •Patients on bisphosphonate or long-term glucocorticoid therapy
- •Hypothyroidism
- •Uncontrolled cardiovascular diseases (e.g., hypertension, coronary artery disease, congestive heart failure)
- •Pregnant and lactating women
- •Local factors:
- •Tobacco users (more than 10 cigarettes per day)
- •Poor oral hygiene
- •Patients with untreated periodontal disease
- •History of radiation in the head and neck area
研究组 & 干预措施
M2 - Cytoplast + bonegrafting
• M2: In the group M2 the site was covered with an alternative d-PTFE membrane (Cytoplast™, Osteogenics Biomedical, Texas, USA)
干预措施: Socket preservation with M2 (Procedure)
M1 - permamem + bone grafting
M1: In the group M1, the grafted site was covered with a d-PTFE membrane (Permamem®, botiss biomaterials GmbH, Zossen, Germany)
干预措施: Socket preservation with M1 (Procedure)
结局指标
主要结局
Scanning electron microscopy analaysis (SEM)
时间窗: Up to 6 months
Description: High-resolution imaging to visualize biofilm morphology and bacterial distribution on the membrane surfaces. Unit of Measure: Qualitative (e.g., bacterial morphology, density). Time Frame: Up to 6 months. This provides an observational outcome focused on the visual and qualitative analysis of biofilm structure.
RT-PCR
时间窗: Up to 8 months
Description: Quantitative analysis of specific bacterial species' presence and relative abundance associated with dental biofilm on d-PTFE membranes. Unit of Measure: Relative abundance (%) of targeted bacterial species. Time Frame: Up to 8 months. This measure captures the presence and amount of particular bacteria in biofilm samples.
Next Generation Sequencing (NGS)
时间窗: Up to 10 months
Description: Assessment of microbial diversity, richness, and specific bacterial composition on two types of d-PTFE membranes after a four-week healing period. Unit of Measure: Diversity indices (e.g., Shannon Index, species richness). Time Frame: Up to 10 months. This measure assesses the overall microbial community composition and diversity on each type of membrane.
次要结局
未报告次要终点
研究者
Marija Čandrlić
Faculty of Dental Medicine and Health
Josip Juraj Strossmayer University of Osijek