Comparative evaluation of bone density and peri implant tissues in implants placed in maxillary anterior segment using osseodensification with and without L-PRF: A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Self
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The aim of the present study is to evaluate and compare bone density and peri implant tissues in implants placed in partially edentulous maxillary anteror segment using osseodensification with and without L-PRF: A clinical and radiographic study.
研究概览
简要总结
| This randomized controlled trial will be conducted to evaluate bone density and peri implant tissues in implants placed in patients with partially edentulous maxillary anterior segment using osseodensification with and without L-PRF |
Total 42 sites will be included in the study which will be divided into following groups:
Group I (Control group): 21 sites for implant placement in maxillary anterior segment using osseodensification alone.
Group II (Test group):21 sites for implant placement in maxillary anterior segment using osseodensification with L-PRF.
All patients will go thorough clinical evaluations, and case histories will be recorded.Cone-beam computed tomography (CBCT) will be performed prior to the surgery to evaluate the quantity and quality of bone as well as to mark the important anatomical landmarks. Additionally, complete blood analyses, including, estimations of blood glucose levels, bleeding and clotting times, and viral screening for HIV, hepatitis B virus, and hepatitis C virus will be carried out.
L-PRF will be prepared according to the protocol.
Crestal and sulcular incisions will be perfomed and a full-thickness mucoperiosteal flap will be raised and reflected. The osteotomy site will be prepared using densah drills in sequential order.
In Group I (Control group) implant placement in maxillary anterior segment using osseodensification alone. In Group II (Test group) implant placement in maxillary anterior segment using osseodensification with L-PRF. The flap will be sutured with 3-0 nonabsorable silk suture.
Standard postoperative instructions will be given, along with antibiotics and analgesics. Suture removal will be done at 7th day. Follow-up visits will be scheduled at 3 and 9 months, postoperatively.
The following clinical parameters will be evaluated:
1. Mombelli’s modified Plaque index (mPI),
2. Mombelli’s modified sulcular bleeding index (mSBI)
3. Implant sulcus depth – will be measured using periodontol implant probe.
4. Ridge width measurement- It will be done using Bone Gauge at 2mm and 4mm from alveolar crest.
5. Gingival thickness- will be done using endodontic spreader with rubber stopper.
- Implant Stability will be evaluated with surgical rachet at the time of implant insertion.
Following radiographic parameters will be evaluated using CBCT at baseline and 9 months.
1. Bone density (BD)– Assessment of bone density will be done on Image J software.
2. Crestal bone height (CBH)
3. Buccal bone thickness (BT)- At the crest, 5mm from crest and 10 mm from crest will be assessed using CBCT.
4. Ridge width (RW) – Bucco-lingual dimension of osseous ridge will be assessed.
5. Vertical distance (VD) between 1st radiographic bone implant contact and 1st implant thread on mesial and distal sides and amount of bone loss on mesial and distal side.
Buccal and Palatal gingival thickness measurement will also be done.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy patients.
- •Patients having partially edentulous spaces in maxillary anterior segment.
- •Patient with healthy and stable soft tissue architecture Co-operative, motivated and hygiene conscious patients.
- •Patient aged above 18 years.
- •Patients who gave written consent for the procedure.
排除标准
- •General contraindications to implant surgery.
- •Patients with a history of irradiation in the head and neck area, within the last 6 months.
- •Patients under treatment with drugs which significantly impact periodontal inflammation and bone turnover Smokers or patients with poor oral hygiene.
- •Patients with severe clenching and grinding Pregnant or lactating females.
- •General bone or Blood disorders.
结局指标
主要结局
The aim of the present study is to evaluate and compare bone density and peri implant tissues in implants placed in partially edentulous maxillary anteror segment using osseodensification with and without L-PRF: A clinical and radiographic study.
时间窗: Baseline 3 months 6 months and 9 months post operatively
次要结局
- To evaluate and compare crestal bone height, implant stability, buccal bone thickness, ridge width and vertical distance in patients with dental implants placed in partially edentulous maxillary anterior segment using osseodensification with and without L-PRF, at baseline and 9 months post surgery using CBCT(To evaluate and compare modified plaque index, sulcular bleeding index, implant sulcus depth, gingival thickness and ridge width in patients with dental implants placed in partially edentulous maxillary anterior segment using osseodensification with and without L-PRF)
研究者
Dr Saurabh Loya
Ranjeet Deshmukh Dental College and Research Centre