Clinical and Optical Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Keratinized tissue width (KTW)
研究概览
简要总结
The present study is a human, prospective, single centre, single blind randomised controlled clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel expander (Osmed®) to gain keratinised tissue around the dentulous area. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
详细描述
Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients.
All the patients were implanted with self-inflating hydrogel expander (Osmed®) in subperiosteal positions using the pouch technique in the mandibular anterior region. The clinical parameters were recorded at baseline, two weeks post expander retrieval, three months and six months post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients willing to participate in the study
- •Patients above 18 years of age
- •Systemically healthy patients
- •Patients exhibiting keratinized tissue width < 2 mm
- •Patients manifesting Miller's Class I or Class II recession
- •Patients who demonstrate good plaque control ( PI < 10% ) and showing good compliance
- •Uncompromised adjacent teeth with healthy gingival conditions
排除标准
- •Untreated periodontal disease, caries
- •Insufficient oral hygiene
- •Thin biotype ( < 0.8 mm )
- •Use of tobacco
- •Previous radiation therapy
- •Patients with known systemic diseases and conditions as uncontrolled diabetes mellitus or haemorrhagic disorders
- •Pregnant and lactating women
- •Non-compliant patients
研究组 & 干预措施
Osmed® hydrogel expander implantation
Implantation of Osmed® hydrogel expander was done in subperiosteal positions using the pouch technique in the mandibular anterior region.
干预措施: Osmed® hydrogel expander implantation (Device)
结局指标
主要结局
Keratinized tissue width (KTW)
时间窗: 6 months
measured from the most apical gingival margin to the mucogingival junction (MGJ), with the MGJ location determined using the visual method (Schiller's potassium iodide solution).
Keratinized tissue thickness (KTT)
时间窗: 6 months
measured at the mid-buccal aspect of the study tooth just below the marginal gingiva using an endodontic file.
Optical scanning for analysis of tissue thickness
时间窗: 6 months
alginate impressions were made at the baseline prior to expander placement, immediately after the removal of expander and 6 months post-augmentation. The prepared casts were assessed for soft tissue changes by optical scan using 3D camera (Intellidenta AG, Basel, Switzerland). The obtained digital images of the casts reflecting the different treatment time were then superimposed and matched in one common coordinate system. The buccal surfaces of the study teeth were used as a reference point for the superimposition of different images. Subsequently, a defined area of interest at each site were measured and the difference in the linear distance between the time points were calculated.
次要结局
- Gingival recession depth (GRD)(6 months)
- Vestibular depth (VD)(6 months)
- Color and texture match to the surrounding tissue(6 months)