Comparative evaluation of peri implant soft and hard tissue healing in dental implants with and without photofunctionalisation in maxillary arch: A randomized controlled trial. ________________________________________
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
This study is a randomized controlled clinical trial designed to comparatively evaluate peri-implant soft and hard tissue healing in dental implants placed with and without photofunctionalisation in the maxillary arch.
Photofunctionalisation is a surface activation technique in which titanium implants are exposed to ultraviolet light prior to placement. This process removes hydrocarbon contamination from the implant surface, restores hydrophilicity, enhances bioactivity, and promotes improved cellular attachment and osseointegration.
The primary aim of the study is to determine whether photofunctionalised implants show superior peri-implant soft tissue healing and hard tissue outcomes compared to non-photofunctionalised implants.
A total of 42 implant sites ,21 in the test group and 21 in the control group will be included. The test group implants will undergo UV photofunctionalisation for 15 minutes before placement, while the control group will receive conventional implants.
Soft tissue parameters will be evaluated using Landry’s Healing Index,Pink Esthetic Score,Plaque index and bleeding index,Probing depth and gingival thickness,Patient satisfaction i.e VAS questionnaire.
Hard tissue parameters will be assessed using Implant stability i.e ISQ values using RFA,Crestal bone height,Bone density,Bone-implant contact via CBCT.
Follow-up assessments will be conducted at baseline, 3 months, and 9 months with early healing index at 7 and 14 days. Statistical analysis will be performed using SPSS, with significance set at p less than 0.05.
The study duration is 18 months, and the results aim to provide clinical evidence regarding the effectiveness of photofunctionalisation in improving peri-implant tissue healing and overall implant success in the maxillary arch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •Patients presenting with edentulous sites in the maxillary arch requiring dental implant placement Systemically healthy patients Patients aged more than or equal to 18 year of age Adequate bone volume in the maxillary arch Good oral hygiene Patients willing to provide informed consent.
排除标准
- •Smokers Systemic diseases affecting bone metabolism Pregnant or lactating females Patients on long-term steroid or bisphosphonate therapy Poor oral hygiene.
研究者
Dr Harshal Lohe
Ranjeet Deshmukh Dental College and Research Centre , Nagpur