Clinical Effect Of UV Irradiated Sandblasted Large Grit And Acid Etched Surface Implant On Implant Stability And Marginal Bone Loss In The Maxillary Posterior Region A Parallel Randomised Double Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the clinical effect of photofunctionalization on implant stability in the maxillary posterior region.
研究概览
简要总结
This randomized double-blinded clinical trial aims to evaluate the effect of ultraviolet (UV) photofunctionalization of sandblasted large-grit acid-etched (SLA) surface implants on implant stability and marginal bone loss in the posterior maxillary region. Biological aging of titanium implants due to hydrocarbon contamination reduces surface wettability and cellular response, which may compromise early osseointegration. UV photofunctionalization reverses this aging by increasing surface hydrophilicity and biological activity.
Seventy systemically healthy patients with healed edentulous posterior maxillary sites will be randomly allocated into two groups: a test group receiving UV-irradiated implants and a control group receiving non-irradiated implants. Implant stability will be assessed using resonance frequency analysis at placement, 4 weeks, and 4 months postoperatively. Marginal bone loss will be evaluated using standardized periapical radiographs at baseline, 4 months, and 1 year.
The study is designed to determine whether UV photofunctionalization enhances early implant stability and reduces marginal bone loss compared to conventional implants, thereby supporting its clinical relevance in improving osseointegration outcomes in the posterior maxilla.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Good oral hygiene and suitability for implant placement.
- •3.Edentulous area in the maxillary posterior region.
- •4.Healed extraction sockets with a history of extraction minimum 6 months ago.
- •5.Systemically healthy patient.
- •6.Patients willing to and fully capable of complying with the study protocol.
排除标准
- •1.Patients who are not cooperating and with systemic co-morbidities that are likely to affect the study outcome (uncontrolled diabetes mellitus, immunocompromised patients, psychological problems, radiotherapy of head and neck region within the past 24 months).
- •2.Severe periodontal problems.
- •3.Conditions requiring bone graft.
- •4.Chronic alcoholism, and smoking.
- •5.When bone or soft tissue regeneration was needed to enhance implant stability or esthetics.
- •6.Patients under medication which are likely to affect the treatment outcome.
- •7.Presence of any parafunctional habits.
- •8.Pregnant or lactating females.
结局指标
主要结局
To evaluate the clinical effect of photofunctionalization on implant stability in the maxillary posterior region.
时间窗: baseline,4 weeks and 4 months
次要结局
- To evaluate the radiographic effect of UV irradiated SLA surface implant on marginal bone loss in the maxillary posterior region(baseline,4 months and 1 year)
研究者
Darshan Khairnar
S. C. B. Dental College And Hospital, Cuttack , Orissa , India