Comparative evaluation of bone density in posterior maxilla in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF- A clinico-radiographic study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effects on bone density in posterior maxilla in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF
研究概览
简要总结
This randomized controlled trial will be conducted to evaluate bone density in posterior maxilla in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with concentrated growth factors (CGF).
Total 42 sites will be included in the study which will be divided into following groups:
Group I (Control Group): Delayed implant placement without any coating in posterior maxilla. (n= 14 Sites)
Group II (Test Group 1): Delayed implant placement with 1% metformin gel coating in posterior maxilla. (n= 14 Sites)
Group III (Test Group 2): Delayed implant placement with 1% metformin gel coating along with CGF in posterior maxilla. (n= 14 Sites)
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.
Metformin gel preparation will be done using appropriate methods.
Crestal and sulcular incisions will be performed and a full-thickness mucoperiosteal flap will be raised and reflected. The osteotomy site will be prepared using drills in sequential order.
In the Group I (Control group), implants will be inserted without any coating in the prepared osteotomy while in Group II (Test group 1) implants will be inserted along with a thin layer of 1% MF gel coating and in Group III (Test group 2) implants will be inserted along with a thin layer of 1% MF gel coating along with CGF. The flaps will be sutured with 3-0 nonabsorbable silk sutures.
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 periodontal 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.
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
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient aged between 20 and 55 years Patient having edentulous space in maxillary posterior region Patients having good general and systemic health Co-operative, motivated and hygiene conscious patients.
排除标准
- •Patients requiring direct or indirect sinus lift procedures Patients with active infection or severe inflammation at planned implant site Patients under treatment with drugs which significantly impact periodontal inflammation and bone turnover Alcoholics, Smokers and patients with poor oral hygiene Patients with severe clenching and grinding Pregnant or lactating females.
结局指标
主要结局
To evaluate and compare the effects on bone density in posterior maxilla in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF
时间窗: baseline, 3 , 6 and 9 months
次要结局
- To evaluate and compare crestal bone height, buccal bone thickness, ridge width and vertical distance in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF(baseline and 9 months)
- To evaluate and compare modified plaque index, sulcular bleeding index, implant sulcus depth, gingival thickness and ridge width in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF(baseline, 3 ,6 and 9 months)
研究者
Tushar Mohata
Ranjeet Deshmukh Dental college and Research Center