Comparative assessment of hard and soft tissue changes in flap and minimally invasive flapless approach in bone-level single-stage implant: A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- 1) Width of Keratinized Mucosa.
研究概览
简要总结
To evaluate clinical and radiographic outcomes in flaps and a minimally invasive flapless approach using a single-stage bone-level implant.
To examine hard and soft tissue changes in the form of marginal bone loss and the width of keratinized mucosa after 1-month, 3-month, and 6-month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Periodontally healthy subjects.
- •Nonsmokers.
- •Age over 18 years.
- •Agreed to follow-up visits for 6 months.
- •Presence of a minimum of 2 mm of Keratinized Mucosa at the labial/Buccal aspects in the implant zone.
- •Minimum crestal bone width 5-6mm (buccolingually).
- •Bone architecture without undercuts and presence of 1 mm of bone buccolingual to the planned position in a favorable prosthetic situation from pre-operative CBCT.
排除标准
- •Subjects with systemic diseases affecting the healing process.
- •Uncontrolled or poorly controlled diabetes.
- •Pregnant and lactating women.
- •Radiation to the head and neck.
- •Subjects requiring guided bone regeneration.
- •Previous implant installation or bone grafting at the Surgical site.
结局指标
主要结局
1) Width of Keratinized Mucosa.
时间窗: 1) The width of Keratinized Mucosa will be evaluated at baseline, 3 months, and 6 months postoperatively. | 2) Marginal bone loss to be assessed: Baseline, 3-month and 6-month post-operatively using RadioVisioGraphy (RVG).
2) Marginal bone loss
时间窗: 1) The width of Keratinized Mucosa will be evaluated at baseline, 3 months, and 6 months postoperatively. | 2) Marginal bone loss to be assessed: Baseline, 3-month and 6-month post-operatively using RadioVisioGraphy (RVG).
次要结局
- Modified plaque index (mPI).(and Modified Sulcus bleeding index)
- Wound healing index.