Evaluation of Soft and Hard Tissue Augmentation by Connective Tissue Graft or Leukocyte-Platelet Rich Fibrin in Immediate Implant Placement With Customized Healing Abutment: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Patient-reported pain experience
研究概览
简要总结
comparison between L-prf and connective tissue with dental implant
详细描述
comparison between L-PRF and Connective tissue with customized healing abutment regaring soft and hard tissue outcomes with immediate dental implants.
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
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intact labial/buccal bone plate
- •The presence of non-restorable single-rooted maxillary centrals, canines or premolars.
- •Sufficient bone volume.
- •Good oral hygiene.
- •Nonsmokers.
- •Sufficient bone width (≥ 1 mm) in the buccal plate of the remaining bone to place an implant confirmed by cone beam computer tomography (CBCT).
排除标准
- •Insufficient bone volume.
- •Active infection.
- •Patients on chemotherapy or radiotherapy.
- •Patients who have systemic disorders {uncontrolled diabetes mellitus, autoimmune disease, ...etc},
- •Pregnant patients,
- •Patients with bone diseases
- •Presence of periapical pathology.
结局指标
主要结局
Patient-reported pain experience
时间窗: first 7 days after surgery
Pain experience after surgery is daily measured by the patients using a visual analogue scale (VAS) in the first postoperative 7 days, with Day 0 being the day of the surgery. Before going to sleep, patients will be asked to mark the VAS that best represented the average pain they had experienced during the day.
Pink aesthetic score
时间窗: before surgery, 3 months and 6 months after surgery
Parameters are : 0,1 and 2. Mesial papilla : 0 ( Missing ) , 1 ( Incomplete ) and 2 ( Complete ). Distal Papilla : 0 ( Missing ) , 1 ( Incomplete ) and 2 ( Complete ). Tissue contour : 0 ( Unnatural) , 1 ( virtually natural ) and 2 ( natural). Gingival level : 0 ( \>2mm) , 1 ( 1-2mm ) and 2 ( 1 mm). Alveolar process : 0 ( clearly resorbed ) , 1 ( slightly resorbed ) and 2 ( no difference). Coloring : 0 ( clear difference ) , 1 ( slight difference ) and 2 ( no difference). Texture : 0 ( clear difference ) , 1 ( slight difference ) and 2 ( no difference).
crestal bone loss
时间窗: preoperative and 6 months post operative
distance from implant shoulder to marginal bone
次要结局
- Gingival thickness(pre opearative, 3 and 6 months post operative)
- probing pocket depth(preoperative , 3 and 6 months post operative)
- keratinized tissue width(preoperative , 3 and 6 months post operative)
- Gingival thickness(pre opearative, 3 and 6 months post operative)
- probing pocket depth(preoperative , 3 and 6 months post operative)
研究者
Ahmed Atef Salem
General dentist
Kafrelsheikh University