Comparative Evaluation of Resorbable (Pericardium) Versus Non Resorbable (Polytetrafluoroethylene) Membrane for Horizontal Bone Augmentation of Posterior Atrophic Mandible
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Osstell Implant Stability Quotient (ISQ)
研究概览
简要总结
the purpose of this study is to compare the efficiency of non-resorbable membrane versus resorbable membrane in guided bone regeneration in atrophic posterior mandible.
详细描述
Lack of adequate bone for implant placement due to a previous history of periodontal disease, traumatic tooth extraction, or bone loss from prolonged use of a removable prothesis, is a common challenge in implant dentistry . Bone loss after tooth extraction has been reported to range between 40% and 60% during the first 3 years, and thereafter it is estimated to range between 0.25% and 0.5% annually .
Alveolar atrophy refers to the pathological condition where there is moderate to severe resorption of alveolar bone due to tooth loss . When teeth are lost, the functional stimulus for the alveolar bone is also lost, leading to predictable bone resorption The pattern of resorption varies based on location, where in the mandible, alveolar bone resorption is primarily horizontal, while in the interforaminal regions, it tends to be centripetal and in retroforaminal areas, the resorption is vertical and centrifugal. The presence of the inferior alveolar nerve (IAN) further complicates treatment in the posterior regions of the mandible when using Osseo integrated implants. These challenges necessitate careful planning and consideration during implant placement to achieve successful outcomes.
Various methods are employed to regenerate bone in areas with deficiencies, including using autogenous or allogeneic block grafts (cortical, cancellous, or cortico-cancellous), ridge splitting techniques, distraction osteogenesis, orthodontic tooth movement, and guided bone regeneration (GBR) with or without additional filler materials.
Numerous materials have been utilized for bone regeneration, with ongoing research in this field to address bone defects. Particularly in the context of widespread implant usage, various options such as autogenous bone, allogeneic bone, and synthetic bone have been employed to treat oral and maxillofacial bone defects . Although fresh autogenous bone yields optimal regeneration results due to its osteoinductive and osteoconductive properties, it comes with drawbacks like pain and edema from donor site injury, limited harvest volume, and high graft resorption rates. Consequently, allogeneic bone graft materials, lacking inherent bone regenerative capacity but obviating the need for an additional donor site, have gained significant use. However, due to their source from other individuals, these tissues may provoke an immune response in recipient tissues, posing a potential antigenic challenge.
Barrier membranes play a crucial role in guided bone regeneration (GBR), with various types being utilized resorbable (pericardium collagen …) and non-resorbable membrane. (e-PTFE,d-PTFE….).
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
- Double (Participant, Outcomes Assessor)
盲法说明
oral pathologist
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mandibular posterior atrophic alveolar ridge Required horizontal bone augmentation procedures prior to implant placement.
- •Alveolar bone height suitable for implant placement.
- •Free of any local or systemic condition that may contraindicate ridge expansion procedure
- •The capacity to understand and accept the conditions of the study.
- •Continuing participation over at least 1 year of follow-up.
排除标准
- •Heavy smokers (i.e., 2 or more packs of cigarettes per day);
- •Insufficient oral hygiene
- •Acute local or systemic infection
- •Patients with any systemic disease that may affect bone healing;
- •Pregnancy or the possibility of becoming pregnant during the study; and
- •Addiction to drugs or alcohol
研究组 & 干预措施
guided bone regeneration using Resorbable membrane pericardium
A resorbable pericardium membrane will be fixed with titanium pins on the lingual bone plate (2-3mm from the bone crest) and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Overfilling of the graft will be respected to compensate for future resorption. The membrane will be stretched over the graft ensuring maximum immobilization of the graft.
干预措施: guided bone regeneration using Resorbable membrane pericardium (Procedure)
guided bone regeneration using non resorbable membrane polytetrafluoroethylene PTFE
A non-resorbable polytetrafluoroethylene (PTFE) membrane will be fixed with titanium tacks on the lingual bone plate (2-3mm from the bone crest) and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Overfilling of the graft will be respected to compensate for future resorption.
干预措施: guided bone regeneration using non resorbable ptfe membrane (Procedure)
结局指标
主要结局
Osstell Implant Stability Quotient (ISQ)
时间窗: 6 months after the surgery at the time of implant placement
measure the implant stability in both group using osstell machine ,The ISQ scale ranges from 1 to 99, with higher values indicating greater stability
change from baseline in pain as measured by the visual analogue scale VAS
时间窗: baseline,12 weeks
pain sensation measured by VAS visual analogue scale score of both group the VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain. scores are measured on a 100 mm VAS
次要结局
- Horizontal bone gain measured using CBCT in mm(6 months)
- Qualitative bone assessment using histological and histomorphometric analysis to measure the % of bone(6 months)
