''Erythropoietin Gel as an Adjunct to Split-Thickness Apically Positioned Flap in Augmentation of Attached Gingiva'' (A Randomized Controlled Clinical Study)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
This study will be carried out to evaluate the effect of topical application of erythropoietin gel as an adjunct to split-thickness apically positioned flap regarding Wound Healing and the Effect on post-surgical symptoms [ Patient Satisfaction] (1ry objective) and Clinical gain in width of attached gingiva. (2ry objective).
详细描述
The gingiva is divided into three parts anatomically: marginal, attached, and interdental. Attached gingiva, as defined by Orban, is the part of the gingiva that is firmly attached to the underlying tooth and bone and is stippled on the surface.
From the base of the gingival crevice to the mucogingival junction, lays the attached gingiva which is the firm resilient component of the gingiva. Through connective tissue, it is closely adhered to the underlying periosteal tissues of alveolar bone. To stabilize the marginal gingiva and resist external harm, an adequate zone of attached gingiva is required.
Lang proposed in 1972 that periodontal tissues require at least 2 mm of attached gingiva to maintain their health and survive the functional pressures of mastication and tooth cleaning. Gingival recession can be exacerbated by insufficient width or thickness of attached gingiva.
Many surgical procedures, such as apically positioned flaps, connective tissue grafts, and free gingival grafts, have been described to enhance the width of attached gingiva.
The apically positioned flap was one of the strategies that allowed surgeons to preserve and extend the width of attached gingiva. Two vertical incisions are made to release a complete full-thickness flap of gingiva and alveolar mucosa. The gingiva, alveolar mucosa, periosteum, and all structures within this flap are all shifted apically and sutured into place so that the flap's margin just covers the alveolar crests. With this surgical procedure, there was a risk of crestal bone resorption and additional attachment loss.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females within age range of 20-40 years.
- •Patients free of systemic diseases according to Burket's oral health history questionnaire .
- •Patients who can follow and maintain oral hygiene instructions.
- •Patients having insufficient width of attached gingiva (<2mm) in labial aspect of lower anterior or premolar teeth and Miller Class I recession .
- •Thick gingival phenotype.
排除标准
- •Pregnant and lactating females
- •Unwillingness or inability to return for follow-up appointments
- •High frenum attachment
- •Crowding of test site teeth
- •Vulnerable patients (those with mental or physical impairments).
研究组 & 干预措施
Test Group
Split-thickness Apically Positioned Flap with topical Erythropoietin (Test group):
A split thickness horizontal incision will be done at the mucogingival junction of the targeted area to be augmented with a scalpel with blade number 15C. Around the teeth, the gingiva stays intact coronal to the horizontal incision. The horizontal incision will extend mesio-distally in accordance with the area to be augmented.(Mandibular anterior or premolar teeth).
A split-thickness flap is elevated, and the dissection is extended as far as necessary in the apical direction. The flap is secured to the periosteum with simple interrupted bio absorbable sutures.
A Chitosan based Erythropoietin gel will be prepared. 1 mL of EPO-loaded with chitosan 5% and β-glycerophosphate disodium salt (GP) 20% gel will be used. The patient will be instructed to use the gel on the surgical site two times daily for 14 days.
干预措施: Split thickness Apically positioned flap with Chitosan based Erythropoietin Gel application (Drug)
Control Group
Split-thickness Apically Positioned Flap without Erythropoietin :
Local anesthesia is administered by infiltration technique. The same surgical procedure is performed with the application of Chitosan gel without being loaded with erythropoietin.
干预措施: Split thickness Apically positioned flap without Erythropoietin application (Drug)
结局指标
主要结局
Patient Satisfaction
时间窗: 1 month
By using a 10 cm horizontal visual analogue scale. The patients will be asked to rate the degree of pain Zero represents the least amount of pain and ten represents the most amount of pain.
Wound healing
时间窗: 21 days
Using toluidine blue epithelialization test to asses the wound healing. The surgical site will be stained with toluidine blue stain. The darkly stained bluish patches will be interpreted as wound sites that are still healing and have insufficient surface epithelialization. The darkly stained areas will be photographed and then uploaded to a picture editing software to determine their surface area using digital tracing.
次要结局
- Width of Attached Gingiva(1 month)