To explore the synergistic influence of vitamin D and vitamin K and its supplementation on bone remodeling process in conventional dental implants – an interventional study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Radiographic parameter through 1. Orthopantomography (OPG)
研究概览
简要总结
The methodology of this interventional clinical study involves enrolling 34 patients aged 20 to 50 years who require dental implant rehabilitation, at the Department of Periodontology, Bangalore Institute of Dental Sciences. Participants will be divided into two groups based on their baseline serum vitamin D levels. Group A will include individuals with sufficient vitamin D levels (that is more than 30 nanograms per milli liters, sample size of 17), while Group B will consist of those with low vitamin D levels (less than 30 nanograms per milli liters with sample size of 17), who will receive a combination of vitamin D3 (60,000 IU per week) and vitamin K2 supplementation (100 micrograms) for four weeks before and after implant placement. All participants will receive a single-stage, coated, tapered root-form dental implant following standard surgical protocols guided by CBCT evaluation. Clinical parameters such as Plaque Index, Gingival Index, gingival phenotype, width of keratinized mucosa, and full-mouth periodontal probing depth will be recorded. Radiographic assessments including cone-beam computed tomography (CBCT) and orthopantomograms (OPG) will be used to evaluate bone type, bone mineral density, will be assessed before implant placement and 3 month after implant placement and crestal bone loss will be assessed 1 month and 3 month post implant placement. Biochemical analyses will include serum levels of 25-hydroxy vitamin D and vitamin K using liquid chromatography, as well as osteocalcin levels in peri-implant sulcular fluid (PISF) at baseline (7th day), 1 month, and 3 months post-implant placement using ELISA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who have edentulous areas in either the mandibular or maxillary region, or both, are suitable candidates for implant-based rehabilitation.
排除标准
- •Any systemic or debilitating illness that impacts bone health (e.g., uncontrolled diabetes mellitus, osteoporosis)
- •Pregnant, lactating, and post-menopausal females.
- •History of radiation to head and neck.
- •Patients requiring ridge augmentation procedures.
- •Individuals who regularly use anti-inflammatory medication and steroids.
- •Regular intake of any medication that impacts on bone metabolism.
- •(e.g., Anti-convulsants, opioids, anti-depressants).
结局指标
主要结局
Radiographic parameter through 1. Orthopantomography (OPG)
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
2.Cone – beam computed tomography (CBCT) – to assess
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
a. Type of the bone
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
b.Bone Mineral Density
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
c.Crestal bone loss
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
Biochemical analysis
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
1. Serum 25-hydroxy vitamin D levels
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
2. Serum vitamin K levels
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
3. Peri-implant sulcular fluid Osteocalcin level
时间窗: The study evaluated clinical, radiographic, and peri-implant sulcular fluid osteocalcin parameters at baseline (7 days post-implant), 1 month, and 3 months. Serum 25-hydroxyvitamin D and vitamin K levels were assessed prior to implant placement. In patients with vitamin D deficiency, serum levels were reassessed after supplementation before implant placement. Serum vitamin K levels were also reassessed at 3 months post-implant placement.
次要结局
- 1. Plaque Index -Turesky – Gilmore – Glickman modification of Quigley Hein Plaque Index 1970(2. Gingival index - Loe & Silness 1963)
- 1. Plaque Index - Turesky – Gilmore – Glickman modification of Quigley Hein Plaque Index 1970(2. Gingival index - Loe & Silness 1963)
研究者
DR BHOOMIKA T M
BANGALORE INSTITUTE OF DENTAL SCIENCES