Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Keratinized tissue width
研究概览
简要总结
Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement & simultaneous FGG or the conventional FGG protocol prior to implant placement.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults at or above the age of
- •Lower Posterior missing tooth/ teeth with minimal KT < 2mm
- •Sufficient alveolar ridge length minimum 13-15 mm to IAN
- •. Sufficient alveolar ridge width minimum of 6 mm
- •Patients able to tolerate surgical periodontal procedures.
- •Patients who provided an informed consent and accepted the one-year follow-up period.
排除标准
- •Patients diagnosed with periodontal diseases (Caton et al., 2018).
- •Current or previous smokers.
- •Pregnant and lactating females.
- •Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
- •Patients with active infection related to the site of implant.
- •Patients with parafunctional habits.
- •Patients with shallow vestibule
研究组 & 干预措施
One Step Protocol
FGG simultaneous with delayed implant placement
干预措施: One Step Protocol (Procedure)
Two Steps protocol
Conventional FGG protocol, prior to implant placement
干预措施: Two Steps Protocol (Procedure)
结局指标
主要结局
Keratinized tissue width
时间窗: 12 months
Optical scans using intraoral scanner (Runyes® Model V5) were obtained at baseline, 3, 6 and 12 months post-operative for each patient. All the optical scans in standard tessellation language (STL) format, were imported to the digital software (Exocad). The best-fit algorithm was used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. KTW (mm) was measured from the preoperative MGJ to the new MGJ using distance measurement tool in the software. KTW measurements were taken at mesial, mid-buccal and distal sites on the buccal side of the implant, values at the three sites were then averaged. Difference between KTW baseline and KTW follow-up was then analyzed to present the changes in KTW
次要结局
- Survival Rate(12 Months)
- Bucco-lingual width bone changes(12 Months)
- Total volume Changes(12 months)
研究者
Ahmed Abo El Futtouh
CEO and Clinical Director
International Dental Contiuing Education