Comparison of Intrasinus and Extrasinus Approach for the Placement of Zygomatic Implants in Severely Resorbed Edentulous Maxillary Arch Using Zygomatic Success Code - An In-Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Zygomatic implant stability
研究概览
简要总结
Various approach has outlined in the literature but no clinical studies that have compared the intrasinus and extrasinus approach for the placement of zygomatic implants using zygomatic success code.
The present study is planned to compare the intrasinus and extrasinus approach for the placement of zygomatic implant in severely resorbed edentulous maxillary arch using zygomatic success code.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous maxilla.
- •Both gender without any systemic disease.
- •Patients with Misch-Type III edentulous maxillary arch and with Seibert's Class III ridge.
- •ZAGA-4 patients (pronounced buccal concavities of the maxilla).
排除标准
- •Any systemic illness/medications
- •Radiation therapy to the head and neck region 12 months prior to the proposed therapy.
- •Pregnant and lactating women
- •Drug allergy
- •Bisphosphonates medication
- •Alcohol/ drug addiction
- •Maxillary sinusitis
研究组 & 干预措施
INTRASINUS
PARAMETERS ASSESED:
- IMPLANT STABILITY
- SINUS PATHOLOGY
- SOFT TISSUE CONDITIONING
- PROSTHETIC OFFSET 18 SAMPLES INCLUDED
干预措施: ZYGOMATIC IMPLANT KIT (Procedure)
EXTRASINUS
PARAMETERS ASSESED:
- IMPLANT STABILITY
- SINUS PATHOLOGY
- SOFT TISSUE CONDITIONING
- PROSTHETIC OFFSET 18 SAMPLES INCLUDED
干预措施: ZYGOMATIC IMPLANT KIT (Procedure)
结局指标
主要结局
Zygomatic implant stability
时间窗: Implant stability was evaluated individually after 3 and 6 months of implant placement and prosthetic rehabilitation
When extra-sinus and intra-sinus placed implants are tested individually, slight mobility should be detected with no other associated pathological signs. Instrument used for checking the implant stability is periotest. Mobility of the implant comes from the elastic modulus of the anchoring zygomatic bone when they are bent by a remotely applied force. On the other hand, the movement must not be rotational, and it will disappear when implants are splinted together. A rotational movement should be considered as a sign of implant failure. Grade I- no mobility, no pain Grade II-light clinical mobility, no pain Grade III-clear clinical mobility, no pain (no evidence of disintegration of the apical part of the implant or rotation Grade IV- clear clinical mobility, rotation and pain evidence of disintegration of apical part of the implant)
次要结局
- Associated sinus pathology(Associated sinus pathologywas assessed at 3 and 6 months after implant placement)
- Peri-Implant Soft Tissue Condition(Soft tissue around the zygomatic implant was assessed at 3 and 6 months)
- Prosthetic Offset(Prosthetic Offset assessed at 3 and 6 months)