Comparative evaluation of immediate versus delayed loading on peri-implant bone levels and tgf-alpha levels in peri-implant crevicular fluid - A clinico-biochemical study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- To evaluate and compare levels of TGF –alpha in PICF around immediate and delayed loaded implants at 15 days, 1 month and at 3 months and to evaluate and compare the marginal bone loss at baseline to 3 months
Study Overview
Brief Summary
Introduction - According to Albrektsson (1993), a successful implant should sustain less than 1.5 mm of bone loss during the first year and less than 0.2mm annually thereafter. The assessment of marginal bone loss around implants is carried out by means of periapical radiographs and more recent advances like cbct. Another important aspect is primary and secondary implant stability. Primary implant stability directly dependents on bone quality. A promising tool for assessing peri-implant bone formation is the detection of specific biomarkers in peri-implant crevicular fluid. Tgf-alpha is an important biomarker during the first stages of osseointegration, a fibrin-rich vascularized matrix populated by fibroblast-like cells is created providing a template for future bone.
Aim - the aim of this present study is to evaluate and compare the peri-implant bone loss between immediate and delayed loaded implants.
Materials & methods - For group a, 8 sites indicated for replacement of missing tooth with more than 6mm width and 10mm height of bone will be taken for implant placement with immediate loading followed by placement of healing abutment. Acrylic crown will be placed within 72hrs. For group b, 8 sites indicated for replacement of missing tooth with sufficient height of bone will be taken for implant placement with delayed loading followed by placement of healing abutment. Picf samples will be collected at 15 days, 30 days and 90 days. Isq and crestal bone levels will be measured at baseline and 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects aged above 18 years requiring Implant placement.
- •Patients with adequate oral hygiene status
- •No active periodontal disease
- •Sufficient bone quality (D1, D2 and D3) and quantity
- •Proper inter-occlusal space in missing tooth region
- •Patients who are willing to comply with the treatment protocol
- •Extraction must be done at least 3 months prior to treatment.
Exclusion Criteria
- •Patients with uncontrolled diabetes.
- •Patients with autoimmune diseases, psychiatric disorders, osteoporosis
- •Patients undergoing or who underwent radiation therapy and chemotherapy to the head and neck region during the last 12 months
- •Patients with poor oral hygiene
- •Alcoholic, drug abusers and heavy smokers
- •Pregnant and lactating women
- •Sites with acute infection.
Outcomes
Primary Outcomes
To evaluate and compare levels of TGF –alpha in PICF around immediate and delayed loaded implants at 15 days, 1 month and at 3 months and to evaluate and compare the marginal bone loss at baseline to 3 months
Time Frame: Baseline- 3 months
Secondary Outcomes
- Comparision of bleeding on probing and ISQ measurements between immediate and delayed loaded implants at baseline and 3 months.(Baseline- 3 months)
Investigators
SHREYA MISHRA
ITS DENTAL COLLEGE