Evaluation Of Dehydrated Amniotic Membrane (Amnioguard®) On Root Coverage Of Lower Anteriors- A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of root coverage
研究概览
简要总结
Gingival recession, as described by the American Academy of Periodontology is the displacement of marginal periodontal tissues apical to the cementoenamel junction causing exposure of root.
Gingival recession is a very common finding in all the populations irrespective of age and ethnicity. It mostly occurs due to plaque accumulation resulting in inflammation of gingival tissues. Many other risk factors cause recession which include developmental defect such as bone dehiscence, chronic trauma due to impaction of foreign bodies against the gingiva, frictional injury to the gingiva, abnormal tooth brushing, malpositioning of teeth, gingival ablation, abnormal frenal attachment etc. The exposure of the root surface may lead to problems such as root caries, dentinal hypersensitivity and esthetic problem1.
Many treatment modalities such as pedicle grafts, free gingival grafts have been described that can be used in treating gingival recession. Pedicle graft requires an adjacent donor site with adequate attached gingiva, but it is associated with the disadvantage of formation of gingival recession or loss of gingival height at the donor site. Free gingival grafts and subepithelial connective tissue grafts are obtained from the palate. Although free gingival graft has a good predictability it has a disadvantage of unsatisfactory esthetic results. Subepithelial connective tissue graft is currently the gold standard procedure as it has favorable end results with regard to root coverage and esthetic results. Though it is a gold standard procedure, it has a disadvantage that it requires a second surgical site which causes discomfort and pain at the donor site many a times2.To overcome all these short comings the research has led to the finding of alternative treatments which can provide promising results and patient comfort at the same time.
Recently, allograft alternatives to autogenous tissue grafts have been introduced in the form of dermis tissue products eg. (Alloderm®, LifeCell Corporation, Branchburg, NJ, USA). It has significant advantages over the previous freeze dried skin allografts. It is free of all the cell components which are also potential mode of disease transmission. In addition, the integrity of the extracellular matrix is maintained, which was otherwise responsible for inflammatory response associated with the earlier available freeze-dried skin allografts. These unique characteristics make the acellular dermal matrix allograft completely biocompatible and safe. However, the unavailability of this material and cost factor had further made the researchers to look for newer materials which could be readily available3. An additional allograft of alternative origin was derived from human amnion tissue. Though it had been used since 1900’s for skin grafts, burn wounds and ulcers only recently it got recognized in dentistry. It is derived from the amniotic sac that encloses the developing fetus during the gestation and is composed of amnion and chorion tissue.
Amnion lines the inner most portion of the amniotic sac and consists of a single layer of epithelium cells, thin reticular fibers (basement membrane), a thick compact layer, and a fibroblast layer. The basement membrane contains collagen types III, IV, and V and cell-adhesion bioactive factors including fibronectin and laminins. The amniotic basement membrane closely mimics the basement membrane of human oral mucosa. A particular fact regarding it is that this amnion layer possesses several types of laminins with Laminin-5 being the most prevalent. Laminin-5 plays a role in the cellular adhesion of gingival cells and concentrations of this glycoprotein in amniotic allograft can be useful for periodontal grafting procedures. Amnion tissue also contains growth factors that may aid in the formation of granulation tissue by stimulating fibroblast growth and neovascularization. The cells found within this tissue exhibits characteristics associated with stem cells and they may enhance clinical outcomes of periodontal surgeries4.
As sparse literature is available regarding the dehydrated amniotic membrane in the field of reconstructive periodontal surgery and very few studies are there related to the treatment of recession in lower anteriors, the current study was aimed to evaluate the clinical efficacy of dehydrated amniotic membrane(Amnio-guard®) in the recession coverage of the mandibular anteriors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients who had signed an informed consent.
- •2.Patients who were systemically healthy patients, both males and females in the age range of 18-50 years.
- •3.Patients with recession in the mandibular anterior region with Miller’s class I or II gingival recessions.
- •4.Patients with recession depth of ≥3mm but less than 5mm.
- •5.Patients with well aligned teeth.
- •6.Patients who were able to and willing to follow study procedures and instructions.
- •7.Patients who were compliant and maintained good plaque control.
排除标准
- •1.Patients who did not provide consent for the study.
- •2.Patients who had gingival recession (class III and IV) with interdental bone loss.
- •3.Thin gingival biotype (<1.5mm gingival thickness) 4.Teeth with restored cervical abrasions.
- •5.Pregnant/lactating women.
- •6.Patients who were known smokers or who were using smokeless tobacco.
- •7.Patients who had root caries.
- •8.Patients with any immunologic disease and who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which would compromise wound healing and preclude periodontal surgery.
结局指标
主要结局
Percentage of root coverage
时间窗: At 1 week ,3months and 6 months
Gain in width of keratinized gingiva
时间窗: At 1 week ,3months and 6 months
To evaluate the regenerative potential of dehydrated amniotic membrane using the following clinical parameters:
时间窗: At 1 week ,3months and 6 months
Improvement in clinical attachment level
时间窗: At 1 week ,3months and 6 months
次要结局
- 2.To assess esthetic outcome following the use of dehydrated amniotic membrane.(6 months)
