Comparative Evaluation Of Clinical Outcomes Between Dental Implants Coated With And Without Injectable Platelet Rich Fibrin In Posterior Mandibular Edentulous Region – A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To measure and compare Implant stability quotient
研究概览
简要总结
Dental implant success largely depends on rapid and stable osseointegration between the implant surface and surrounding bone. Various biological modifications have been explored to enhance early implant healing and implant stability. Injectable platelet-rich fibrin (i-PRF) is an autologous platelet concentrate rich in platelets, leukocytes, and growth factors that promote angiogenesis, osteogenesis, and tissue regeneration. The i-prf is prepared by drawing 10 ml of patient’s blood and centifuging at 700rpm for 3 minutes
Coating dental implants with i-PRF prior to placement may create a biologically active fibrin matrix on the implant surface that facilitates enhanced cellular adhesion, growth factor release, and early bone formation at the implant–bone interface. This may improve early implant stability and potentially enhance the osseointegration process.
The present study will be conducted as a randomized controlled clinical trial involving 20 participants requiring dental implant placement, who will be randomly allocated into two groups (10 participants in each group). The test group will receive implants coated with i-PRF prior to placement, while the control group will receive implants placed using the conventional protocol without i-PRF coating.
The primary outcome measure will be implant stability quotient (ISQ) assessed using resonance frequency analysis at baseline (week 0), week 1, week 6, and week 12 following implant placement. The secondary outcome measure will be the width of keratinized gingiva around the implant site, measured clinically by applying iodine solution and meausred in millimeters using a periodontal probe.
The inclusion criteria includes Patients with edentulous region in mandibular posterior posterior region.
Patient who want Implant processes in their edentulous region.
Patient with adequate height and width in posterior region for Implant placement .
systematically healthy patients .
patients with the ability to maintain oral hygiene .
patients who are willing for voluntary participation and have signed inform consent
the exclusion criteria includes Patients who have received periodontal flap or regenerative therapy within the past one year
Patients with para functional habits and Bruxism
Patients who demonstrate poor hygiene maintenance
Patients with known systemic diseases, metabolic disorders
Patients under medication known to affect the outcome of the periodontic therapy
Patients under any medication that alters bone morphology
Patients using any form of tobacco
Patients who are alcoholics
Pregnant and lactating women
Patient with known allergies
Patients undergoing radiation therapy or history of radiation within the last two years
The results of this study aim to evaluate whether i-PRF coating of implant surfaces can improve early implant stability and peri-implant soft tissue parameters, thereby contributing to improved clinical outcomes in implant therapy
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 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with edentulous region in mandibular posterior posterior region.
- •Patient who want Implant processes in their edentulous region.
- •Patient with adequate height and width in posterior region for Implant placement .
- •systematically healthy patients .
- •patients with the ability to maintain oral hygiene .
- •patients who are willing for voluntary participation and have signed inform consent.
排除标准
- •Patients who have received periodontal flap or regenerative therapy within the past one year Patients with para functional habits and Bruxism Patients who demonstrate poor hygiene maintenance Patients with known systemic diseases, metabolic disorders Patients under medication known to affect the outcome of the periodontic therapy Patients under any medication that alters bone morphology Patients using any form of tobacco Patients who are alcoholics Pregnant and lactating women Patient with known allergies Patients undergoing radiation therapy or history of radiation within the last two years.
结局指标
主要结局
To measure and compare Implant stability quotient
时间窗: week 0, week 1, week 6, week 12
次要结局
- to evaluate width of keratinised gingiva(12 weeks)
研究者
Mohamed Riyaz J
Tamil Nadu Government Dental College and Hospital
