Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
Periodontal diseases are one of the most prevalent chronic diseases involving a spectrum of inflammatory conditions. Intrabony defects, also known "vertical defects," are specific osseous and morphological defects and one of the consequences and end result of periodontitis. Intrabony defects are particularly associated with periodontal progression however certain patient-related factors play important role in its management such as plaque management, smoking, medical history, tooth mobility and endodontic condition.
Periodontal repair is aimed to gain periodontal attachment using various modalities in severely compromised teeth, decrease pocket depth, and stabilize gingival recession. Different types of biomaterial substitutes and bone graft materials are available, but the choice of suitable "golden" type or technique is difficult and dependent on various factors particularly anatomical variations, cost effective, clinical situations, the systemic general condition, operation site, socioeconomic conditions and the surgeon choice.
The current therapeutic options mainly focus on minimize symptoms and prevent disease progression but are not able to fully restore damaged bone and periodontal supporting tissues. Many of these regenerative approaches, (e.g. bone grafts) provided variable and unpredictable clinical outcomes. Therefore, it is imperative to develop alternative regenerative strategies.
There is necessity to introduce novel and alternative materials of natural and synthetic origins for bone grafting use in dental field. This requires well performed clinical trials on humans to understand the effects of such materials (e.g the marine algae-based substitutes and biodegradable (absorbable) materials) either as a single or combined formula.
The aim of the current clinical study is to evaluate the clinical efficacy of an algae-based biphasic bone graft material (AlgOss 20/80) and collagen membrane in the treatment of patient with intrabony periodontal defects.
详细描述
Study population Recruited patients attending the dental clinic at the faculty of dentistry of the University of Cairo, Egypt will be included following the study eligibility criteria.
Population: Patients with periodontal intrabony defects (Stage III and IV periodontitis).
Intervention: Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.
Control: Conventional flap with collagen membrane.
Outcomes:
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age is between ≥ 20 to ≤ 65 years old.
- •Presence of intrabony defect
- •Systematically free.
- •The subjects understand the purpose of the study, adhere to the study protocol and given consent to be included in the study.
- •Adequate plaque control and stable periodontal status (full-mouth bleeding score on probing: <25%, and full- mouth plaque score: <25%)
排除标准
- •Any infection particularly at the intervention site.
- •Teeth mobility more than grade
- •Pregnant or lactating women.
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
The CAL will be measured from the cementoenamel junction (CEJ) to the base of the sulcus or pocket
次要结局
- Probing pocket depth (PPD)(From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.)
研究者
Rahma Omar B. Ahmed
Principal Investigator
Cairo University