Effect of Emdogain On Dental Implant Osseointegration: A Clinico-Radiographic Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
The study aims to compare the clinical, radiographic, and osseointegration outcomes between Emdogain coated implants and conventional titanium implants over a 6-month follow-up period, thereby evaluating the potential role of Emdogain in enhancing peri-implant tissue healing and implant integration. This randomized, controlled clinical study is designed to evaluate the effect of Enamel Matrix Derivative (Emdogain) applied to dental implant surfaces on peri-implant soft and hard tissue outcomes, as well as on early osseointegration. The study will be conducted on 20 systemically healthy subjects (18–65 years) reporting to the OPD of the Department of Periodontics & Oral Implantology, KIDS, KIIT Deemed to be University, Bhubaneswar, who are indicated for dental implant placement.
A total of 26 implant sites will be randomly allocated into two equal groups: Group A, receiving implants placed by the conventional protocol, and Group B, receiving implants coated with Emdogain prior to placement. Standardized pre-surgical periodontal evaluation, oral prophylaxis, and CBCT assessment will be performed for all participants. Implants will be placed under local anesthesia following manufacturer-recommended drilling protocols. In Group B, Emdogain will be topically applied to the implant surface before insertion.
Clinical parameters including periodontal probing depth, gingival biotype, and wound healing index will be assessed, while radiographic evaluation of bone density and crestal bone levels will be performed. Assessments will be recorded at baseline (immediate post-implant placement), 3 months, and 6 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients after PSR screening code 0, 1,
- •Patients without any systemic disease.
- •Patients with enough mesiodistal and interocclusal space or crown height space of 8-12mm.
- •Patients with D2-D3 bone density.
排除标准
- •Patients with medical history that can contradict dental treatment placement including uncontrolled diabetes.
- •Patients with recent history of heart surgery, heart attack or stroke within 6months, history of radiotherapy/ chemotherapy for malignancy over past 5 years.
- •Patients on long-term steroid, anticoagulant or bisphosphonate therapy.
- •Pregnant, lactating women.
- •Patients with history of allergy.
- •Patients with inadequate oral history with plaque score more than 3 Chronic smokers.
- •Patient with parafunctional habits, temporomandibular joint disease.
- •Presence or sign of active infection and pus formation in implant site.
- •Patients undergoing orthodontic treatment.
- •Patient who is not willing to participate will be excluded.
研究者
Sushrima Dey
Kalinga Institute of Dental Sciences