Volumetric Assessment of Volume Stable Collagen Matrix in Soft Tissue Ridge Augmentation At Maxillary Single Implant Site
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- volumetric changes of soft tissue at implant sites with siebert class I
研究概览
简要总结
This proposal suggests the use of a collagen scaffold as a core material for GBR in the case of a missing tooth between two existing teeth, in situations where there is sufficient bone to place an implant but a horizontal defect is present in the ridge.
The tested question is whether a thick, reinforced, resorbable collagen scaffold can provide a stable basis for restoring the lost volume of a deficient ridge. As a secondary aim, a positive result could present an option to replace the connective tissue interpositional graft procedure.
详细描述
• Surgical procedure and clinical measurements:
Pre-surgical phase:
- Full Conventional non-surgical periodontal therapy involving supra, sub gingival scaling and root planning will be performed
- Oral hygiene instructions will be repeated until patients had achieved a proper degree of oral hygiene where plaque index (PI) ≤ 1.
- Four weeks later, patients will be re-evaluated in order to confirm the efficacy of cause related therapy phase.
- Clinical parameters and CBCT will be recorded prior to surgery.
- Full arch impressions will be recorded with high viscosity impression material. Baseline casts will be made to be used as a reference for volumetric measurements.
- Surgical protocol:
- Patients will undertake implant surgery under local anesthesia for the missing tooth using mid crestal incision at the edentulous area and sulcular incisions at the neighboring mesial and distal teeth.
- A combined full / partial thickness flap will be made followed by implant placement and healing screw is connected to the implant.
- For group 1 VCMX will be utilized to graft the buccal defect and primary closure will be achieved using simple interrupted sutures.
- For group 2 CTG will be utilized to graft the buccal defect and primary closure will be achieved using simple interrupted sutures.
- Postoperative medications will include (Augmentin 1g twice/day, Flagel 500 mg twice daily and 2 weeks of antiseptic mouth wash ).(Deeb et al , 2015)
- Patients will be given post-operative instruction and sutures will be removed after 2 weeks.
- The final abutment will be secured to the implant within 12 weeks after gingival healing for definitive crown placement.
Postoperative surgical evaluation and assessment:
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients in a healthy systemic condition.
- •Both genders with age ranging from 20 to 50 years old.
- •Patients should have single missing tooth in anterior or premolar area.
- •Seibert Class I ridge defect.
- •Sufficient bone height and width that doesn't necessitate bone grafting or any other ridge augmentation protocols.
- •Healing period of 3 months after extraction prior to surgical procedures.
- •Patients should approve to deliver a signature to a written consent after study nature explanation.
排除标准
- •Patients with any smoking habits.
- •Pregnant females, decisional impaired individuals, Prisoners and handicapped patients.
- •Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
- •Patients with infections either periodontally or periapically.
研究组 & 干预措施
Group I (VCMX)
includes 10 patients where implant placement will be performed followed by volume stable collagen matrix placement to augment the buccal defect.
干预措施: volume stable collagen matrix placement (Biological)
Group II (control)
Will include 10 patients where implant placement will be performed followed by connective tissue grafting to augment the buccal defect.
干预措施: connective tissue grafting (Procedure)
结局指标
主要结局
volumetric changes of soft tissue at implant sites with siebert class I
时间窗: 9 months
Is to evaluate the volumetric changes of soft tissues at implant sites with Siebert class I ridge defect after augmentation with volume stable collagen matrix in comparison with connective tissue grafting
次要结局
- patient satisfaction(9 months)
- esthetic outcome(9 months)
研究者
ahmed hamdy mahmoud
assistant lecturer of periodontology
British University In Egypt