Comparative evaluation of efficacy of DFDBA and DFDBA enriched with Vitamin D3 in alveolar socket preservation A Clinical Radiographic and Histologic study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
Tooth extraction is frequently followed by significant bone loss, resulting in reduced alveolar ridge height and width that can compromise subsequent implant placement and aesthetics. Alveolar ridge preservation techniques aim to minimize this bone resorption using bone grafts and adjunctive agents. Demineralized Freeze-Dried Bone Allograft also known as DFDBA is a well documented allograft material for socket preservation due to its osteoinductive potential.
Vitamin D3 plays a crucial role in calcium metabolism and bone remodeling by promoting osteoblastic activity and mineralization. Its topical incorporation into bone grafts may enhance graft integration and new bone formation.
This randomized controlled clinical trial aims to compare the efficacy of DFDBA alone and DFDBA enriched with Vitamin D3 gel in post-extraction alveolar socket preservation. Sixty patients requiring extraction of a single tooth preferably premolar or molar and subsequent implant placement will be recruited and randomly assigned into two groups:
Group I: Socket preservation using DFDBA alone
Group II: Socket preservation using DFDBA enriched with Vitamin D3 gel
Clinical evaluation for assessing soft tissue healing, radiographic assessment for ridge height and width using RVG and CBCT, and histologic analysis for vital bone formation, residual graft, connective tissue content will be performed at baseline and after 6 months.
The study is expected to determine whether Vitamin D3 supplementation enhances the regenerative potential of DFDBA, resulting in improved bone quality and quantity for future implant placement.
Study Design: Double-blinded, randomized controlled clinical trial Study Duration: 18 months Sample Size: 60 participants Study Site: Ranjeet Deshmukh Dental College and Research Centre, Nagpur
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 58.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients above the age of 18 years, Patients with no medical history that contraindicates the surgical procedure, adequate space for a satisfactory implant restoration.
- •Only maxillary and mandibular premolars or molars indicated for extraction, and replacement with dental implant.
Exclusion Criteria
- •Patients with a history of any systemic diseases that might impair bone metabolism, Patients that exhibited poor oral hygiene, Patients demonstrating a buccal dehiscence of more than 25% of the length of the tooth, Edentulous spaces adjacent to the tooth indicated for extraction, Patients who are smokers, Patients on antiresorptive therapy (as bisphosphonates), and Pregnancy and nursing period, psychiatric conditions, and oncologically relevant diseases.
Investigators
Dr Prachi Rathi
Ranjeet Deshmukh Dental College and Research Centre Nagpur