Effect of Guided probiotic colonization of dental implants on clinical outcomes, early healing dynamics and long-term success through immune-regulation: a randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Early Wound Healing Dynamics by measuring following clinical parameters
研究概览
简要总结
Purpose: This Randomized controlled trial will be conducted to evaluate the effectiveness of Bio-modification of dental implant surface through guided probiotic colonization (GPC) on clinical and radiographical outcomes, early wound healing dynamics, and osseointegration by modulating the M1 and M2 immune response in the periodontal extraction sites.
Methods: 50 participants will be selected according to inclusion and exclusion criteria. Informed consent will be taken and they will be divided into 2 groups. for the test group, GPC-modified implants will be placed immediately post-extraction and for the control group normal unaltered implants will be placed immediately post-extraction. Then clinical, radiographical, patient-related, and immunological parameters will be measured and recorded on time for both groups for final analysis.
Results: Analysis of 2 groups will be done by unpaired t test, for more than 2 groups ANOVA followed by Turkey’s post-hoc test and Newmann keuls post-hoc test by graph pad prism will be performed. Spearmann rank correlation test will be done to find a correlation between immune expressions and clinical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 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
- •good general health non smokers or former smokers(not smoked within 6 months of study initiation) no chronic systemic diseases presence of hopeless teeth requiring extraction more than 3mm of bone beyond the root apex presence of four bony walls of the socket with or without dehiscence.
排除标准
- •presence of chronic systemic diseases bruxism habit uncontrolled diabetes coagulation disorders alcohol or drug abuse reduced compliance after oral hygiene sessions complete edentulism mucosal diseases pregnancy or lactation patients withholding consent for participation in the study.
结局指标
主要结局
Early Wound Healing Dynamics by measuring following clinical parameters
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
Modified plaque index Mobelli et al 1987
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
Wound healing index by Wachtel et al 2003 and patient related outcomes by 5 point Likert type scale
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
Modified sulcus bleeding index Muhlemann and son 1971
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
Probing pocket depth by UNC 15 probe
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
Mucosa level
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
Resonance frequency analysis by Osstell instrument
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
Osseointegration by crestal bone loss by long cone parallel technique
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
Immune-regulation by M1 M2 cytokine profiling by ProcartaPlex
时间窗: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
次要结局
- Study the long-term effect of GPC integrated implant in maintaining peri-implant disease free status compared to control group(Supportive implant maintenance protocol and would be evaluated for clinical and radiographical parameters at an interval of every 06 months after study completion. The long term-evaluation of implant survival, MBL and biological complications for at least 5 years after study completion)