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
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Radiographic parameter through 1. Orthopantomography (OPG)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who have edentulous areas in either the mandibular or maxillary region, or both, are suitable candidates for implant-based rehabilitation.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Radiographic parameter through 1. Orthopantomography (OPG)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
DR BHOOMIKA T M
BANGALORE INSTITUTE OF DENTAL SCIENCES