Effectiveness Of Zygomatic and Tilted Implants In All-On-6 Full Arch Rehabilitation For Completely Edentulous Maxilla : A Non-Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Implant stability
研究概览
简要总结
Edentulism compromises chewing efficiency, nutrition, appearance, and quality of life. Full-arch rehabilitation in the maxilla is often challenging due to bone resorption and sinus pneumatization. Traditionally, bone grafting was required; however, tilted and zygomatic implants now provide graftless alternatives. Tilted implants reduce cantilever length and increase prosthetic support, while zygomatic implants engage the zygomatic bone, bypassing the maxillary sinus in cases of severe posterior atrophy.
This non-randomized clinical trial compares the effectiveness of zygomatic implants versus tilted implants in an All-on-6 protocol for completely edentulous maxilla (Beddrosian Zone 1).
Primary Objectives:
- Compare implant stability between zygomatic and tilted implants.
- Assess crestal bone level changes radiographically.
Secondary Objectives:
- Compare ease of surgery and intraoperative time.
- Compare ease of prosthesis fabrication.
- Assess quality of life outcomes (OHIP-14).
Study Design: Non-randomized clinical trial, two groups:
- Group A: Zygomatic implants (n=7)
- Group B: Tilted implants (n=7) Total sample: 14 patients (convenience sampling).
Inclusion Criteria: Patients aged 30–70 years, edentulous maxilla (Beddrosian Zone 1), ASA I/II, consenting and compliant. Exclusion Criteria: Systemic contraindications (e.g., uncontrolled diabetes, blood disorders, irradiation), smoking, poor oral hygiene, pregnancy/lactation.
Intervention: All-on-6 protocol using either zygomatic or tilted posterior implants. Delayed loading (3–6 months). Follow-up: Baseline, 1 week, 3 months, 6 months, and 12 months with radiographic and clinical assessment.
Outcome Measures:
- Implant stability (Resonant Frequency Analysis, manual test).
- Crestal bone level changes (OPG, CBCT).
- Surgical ease & time (VAS, operative time).
- Quality of life (OHIP-14).
- Prosthesis fabrication ease (VAS).
Expected Result: Zygomatic implants may provide superior anchorage and clinical outcomes compared to tilted implants in All-on-6 rehabilitation for severely atrophic maxilla.
Ethics Approval: Obtained from IEC, GDCH Nagpur (Ref: IEC/GDCHN/35/2025, dated 03/03/2025).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
入选标准
- •Patients with Age 30-70 years of all Gender Maxilla with Zone 1 cases according to Beddrosian classification Patients fit for surgical procedures ASA-1 AND ASA-2 Willingness to Provide Informed Consent Patients must be willing to comply with the study’s follow-up protocol and attend required appointments for assessment, including post-surgical visits and radiographic evaluations.
排除标准
- •Blood disorders autoimmune diseases uncontrolled diabetes mellitus metabolic diseases affecting bone Irradiation of the head or neck region Inadequate oral hygiene performance Smoking habit Pregnancy or breast feeding.
结局指标
主要结局
Implant stability
时间窗: Baseline 1 week 3 months 6 months 12 months
Crestal bone level
时间窗: Baseline 1 week 3 months 6 months 12 months
次要结局
- Ease of surgery & intraoperative time(Quality of life)
研究者
dr neha ganpat pawar
Government Dental College and Hospital Nagpur