Clinical and Radiographic Evaluation of the Role of Concentrated Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) in Enhancing the Wound Healing and Stability of Delayed Short Dental Implants With Immediate Loading: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Bleeding On Probing Index (BOP):
研究概览
简要总结
> Evaluation of the wound healing in immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF.
> Detection of the primary and secondary implant stability of immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF.
> Evaluation of the hard and soft tissue thickness after immediate occlusal loading of endosseous delayed short dental implant with or without CGF or A-PRF.
详细描述
The term 'short implant' is subjective. In most publications this is defined as an implant length between 5 mm and 10 mm. The first implants of this type and length of 7 mm were introduced in 1979 by the Bränemark system. Today, most implantology companies offer implants shorter than 8 mm, which has led to their common use in clinically substantiated cases. The use of shorter implants is indicated in the lateral parts of the maxilla and the mandible. These regions are the most predisposed to atrophy because first molars are the first teeth lost in most cases. After their extraction, the atrophy of bone surface develops in 30-90% of cases. The extraction of first molars can also be the cause of further negative processes such as the mesial inclination of second molars towards the hole, which generates improper occlusal loading, leading to local bone atrophy.
The placement of short implants in treating edentulous patients eliminates the need for complicated surgeries to place conventional implants. Patient satisfaction will be increased as it avoids augmentation procedures, which result in short, inexpensive treatment options. Applying short implants in extremely resorbed mandibles (less than 10 mm bone height) might reduce the risk of mandibular fracture during penetration in the symphysis region, preserving the integrity of the lower mandibular cortex. Several studies concluded that many factors directly influence the success rates of short implants: implant diameter, length, number, stress distribution around the implant, marginal bone loss, implant thread design, and loading strategy for the prosthesis.
It was suggested that a short implant provides low-cost, acceptable, time-saving treatment instead of a long implant placed in the augmented bone while rehabilitating a completely edentulous atrophic maxilla. Significant failures occur with long implants in different augmented sites. Also, conventional dental implants had a triple increase in the chance of complications during insertion compared to short implants. A 5mm × 5mm implant gives the same results as a standard long implant placed in augmented bone after three years of loading. The short implant may be the first choice compared to bone augmentation.
Immediate occlusal loading refers to full functional occlusal loading of an implant within 2 weeks of placement. The authors gave guidelines for successful immediate implant loading with implants have good primary stabilization (placement torque of more than 40 Ncm) can be immediately loaded.
Immediate loading protocols are best in situations where the patient cannot tolerate two-stage surgeries or multiple visits; also, improve esthetics, enhance function, and comfort are expected. Concerning marginal bone loss and implant survival rate, the loading protocol is thought to be not relevant in the clinical success. A review suggested no significant difference between conventional and immediate loading protocols for conventional (normal-sized) implants, and this study also confirmed it about short implants. However, another review suggested that clinicians should be cautious about using immediate loading protocols for dental implants in the single-tooth restorations in the anterior maxilla because of probable marginal bone remodeling and gingival changes.
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
- 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
- •Patient aged 18 - 45 years old.
- •Patients maintaining excellent oral hygiene standards.
- •Systemically healthy patient.
- •Single or multiple missing teeth in premolar and molar region.
- •Patients should have adequate bone width volume (>4 mm) and bone density with sufficient mesiodistal and interocclusal space. Bone height (≤10mm).
- •The patient should physically and psychologically be able to tolerate short implant surgical procedure.
- •Patient with a sufficient platelet count (>200,000/mm3) for CGF and A-PRF preparation.
- •Patients who provided informed consent.
排除标准
- •> Presence of active periodontal disease.
- •Patients with a significant medical history which contradicts placement of dental implants such as:
- •Diabetes.
- •Diseases affecting bone metabolism.
- •Patients currently on antibiotics, steroids, hormonal therapy, or medications known to affect bone metabolism.
- •Patients with a history of radiotherapy or chemotherapy, coagulation defects, or currently on anticoagulant treatment.
- •Pregnant or lactating women.
- •Patients with poor oral hygiene.
- •Habits such as khat chewing, smoking and alcohol intake.
- •Insufficient vertical interarch space.
- •Temporomandibular joint disorder.
- •Parafunctional habits.
结局指标
主要结局
Bleeding On Probing Index (BOP):
时间窗: at baseline, after 6 months, and after 12 months.
BOP was regarded as an indicator of inflammation of the periodontal and peri-implant tissues. Gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds a positive finding is recorded.
Peri- implant mucosal tissue index (MTI):
时间窗: at baseline, after 6 months, and after 12 months.
This index was proposed as part of the Toronto study in light of the significance of mucosal inflammation on peri-implant conditions during monitoring. It is based on the appearance, consistency, and texture of the peri- implant mucosa. The scores are listed below: Score 0: Normal mucosa. Score 1: Mild inflammation with slight color change and edema. Score 2: Moderate inflammation with redness, edema, and glazing. Score 3: Severe inflammation, redness, edema, and ulceration.
Jemt papilla index:
时间窗: at baseline, after 6 months, and after 12 months.
Index 0: No interproximal papilla is present. Index 1: Less than half of the height of the papilla is present (less than half of the distance between the imaginary cervical line and the interdental contact point). Index 2: At least half of the height of the papilla is present (half or more than half of the distance between the imaginary cervical line and the interdental contact point, however without filling up all interdental space). Index 3: The papilla is present and fills up the entire interdental space. Index 4: The gingival papilla is hyperplastic and covers part of the crown of the adjacent tooth or denture.
Probing Pocket Depth (PPD)
时间窗: at baseline, after 6 months, and after 12 months.
The distance recorded in mm from the mucosal margin to the base of the pocket. According to the peri- implant condition, the PPD is often deeper (≥6 mm) in disease or shallower (\< 6 mm) in health. It should be emphasized, however, that deep PPD may be identified in the absence of disease in scenarios exhibiting thick crestal mucosa.
Modified plaque index (mPI):
时间窗: at baseline, after 6 months, and after 12 months.
Score 0: No plaque. Score 1: Plaque disclosed by running a probe around the smooth marginal surface. Score 2: Plaque can be seen by the naked eye. Score 3: Abundance of soft matter.
Mucosal recession (MR)
时间窗: at baseline, after 6 months, and after 12 months.
The distance in mm from the implant- abutment connection as a steady mark and the mucosal margin. If the mucosal margin exceeds coronally the implant- abutment connection due to swelling, the MR is positive , while if it is due to implant malposition or loss of support, the margin is apical to the implant- abutment connection and the value is negative.
Keratinized mucosa (KM)
时间窗: at baseline, after 6 months, and after 12 months.
The distance measured from the free mucosal margin to the mucogingival junction at the buccal position line angles and recorded to the nearest mm. Arbitrarily, a 2 mm height was set as a threshold to define sufficient/presence or insufficient/lack.
Gingival thickness Measurement
时间窗: at baseline, after 6 months, and after 12 months.
Before transgingival measurements, a xylocaine spray (10% lidocaine) is applied topically to reduce pain. It is measured by transgingival method from the buccal region using a #20 endodontic file (20 K-files). The measurement is made by transgingival method after determining the point corresponding to the base of the gingival sulcus with a periodontal probe. Then, the transgingival method measurement is made 1 mm apical to this point. An endodontic file with an attached plastic stopper was inserted perpendicularly into the gingiva until it reached the tooth or the bone. The distance between the stopper and the tip of the caliper is measured using a periodontal probe or digital caliper.
次要结局
- Implant stability(at baseline, after 6 months, and after 12 months.)
- Marginal bone loss(at baseline, after 6 months, and after 12 months)
- Bone density Recording(at baseline, after 6 months, and after 12 months)
研究者
Ebrahim Esmail Mohammed Al-Mutawakel
Lecturer in Department of Periodontology-College of Dentistry-Sana'a University
Sana'a University