Comparative Study Of Perforated Versus Non Perforated Collagen Membrane Combined With Nanohydroxyapatite In The Management Of Intrabony Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- CAL
研究概览
简要总结
The ultimate goal of periodontal therapy is the regeneration of periodontal tissues which have been destroyed due to periodontal disease. Different modalities have been proposed to obtain regeneration of periodontal tissues employing various bone grafts, bone substitute materials, guided tissue regeneration (GTR), combination of bone grafts or bone substitutes with GTR, and growth factors.
So, a new, fully synthetic, nanocrystalline, unsintered, phase-pure hydroxyapatite (nano-HA) has been suggested as a potential material for enhancing periodontal and bone regeneration since its chemical composition and crystalline structure correspond to the calcium phosphate component of natural bone and may have greater potential for resorption compared with sintered hydroxyapatite.
A study performed in 2012, on 14 patients with paired intrabony periodontal defects of ≥4 mm participated in split mouth design study. The defects in each subject were randomly selected to receive nano-HA paste in conjunction with papilla preservation flaps or papilla preservation flaps alone. Probing bone levels from a customized acrylic stent and probing pocket depths were measured at baseline and again 6 months following surgery. No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. Both treatments resulted in significant improvements between baseline and 6 months in all clinical and radio-graphic parameters. In conclusion, they found that the nano crystalline hydroxyapatite bone graft in combination with collagen membrane demonstrated clinical advantages beyond that achieved by open flap debridement alone.
The concept of porous guided tissue membrane has been tested recently as a modality that could stimulate bone formation of critical sized bone defects. Kim and co-workers claimed that asymmetrically porous GBR membranes with dual BMP-2 and ultrasound stimulation may be promising for the clinical treatment of delayed and insufficient bone healing. For guided tissue regeneration in periodontal therapy, membrane perforations could allow for gingival stem cells and periosteal cells to take part in supracrestal regeneration. The perforated section of the membranes would stabilize supracrestal fibrin clot through mechanical interlocking of fibrin strands with the membrane pores providing more membrane and clot stability. It has been suggested that regenerative failures may result when the tensile strength of the fibrin clot is exceeded, resulting in a tear and a long junctional epithelium type attachment.
详细描述
The study will be conducted on 12 individuals. The research esthetics committee of Faculty of Dentistry, Ain Shams University will review the proposal.
All patients will be informed about the nature of the study and will fine an informed consent.
I - Selection of the patients:
The patients will be selected from the outpatient clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Ain Shams University.
All the selected patients will be selected according to following criteria:
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)
入排标准
- 年龄范围
- 25 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients free from any systemic diseases as evidenced by health using Burket's Oral Medicine health history questionnaire. (Glick, 2008)
- •Patients' age range from 25 to 50 years old.
- •Each patient should have at least two contralateral intrabony defects which fulfill the following criteria: ** Probing depth ≥ 5 mm.
- •Clinical attachment loss ≥ 5 mm.
- •Radiographic evidence of vertical bone loss using periapical radiographs.
- •Patients are should be willing to participate in the study and should be able to return for the follow up visits.
排除标准
- •Patients with history of periodontal surgery or medications including antibiotics and non-steroidal anti-inflammatory drugs for at least 3 months prior to the initiation of the study.
- •Pregnant females as well as breast feeding mothers.
- •Vulnerable groups as prisoners, mentally disabled, etc...
研究组 & 干预措施
Open flap debridement & perforated&Nano
Perforated collagen membrane and nano-hydroxyapatite and open flap debridement
干预措施: Open flap debridment (Procedure)
Open flap debridement & perforated&Nano
Perforated collagen membrane and nano-hydroxyapatite and open flap debridement
干预措施: Perforated collagen membrane (Other)
Open flap debridement & perforated&Nano
Perforated collagen membrane and nano-hydroxyapatite and open flap debridement
干预措施: Nanohydroxyapetite (Other)
Open flap debridment &Occlusive&Nano
Occlusive membrane and nano-hydroxyapatite and open flap debridement
干预措施: Open flap debridment (Procedure)
Open flap debridment &Occlusive&Nano
Occlusive membrane and nano-hydroxyapatite and open flap debridement
干预措施: Occlusive membrane (Other)
Open flap debridment &Occlusive&Nano
Occlusive membrane and nano-hydroxyapatite and open flap debridement
干预措施: Nanohydroxyapetite (Other)
结局指标
主要结局
CAL
时间窗: Change from base line to 3 months and 6 months
Clinical attachment level
次要结局
- DOD(Change from base line to 6 months)
研究者
Hesham Mohammed Abdallah
Dr.
Ain Shams University
